Vol. 150, No. 17 — August 24, 2016

Registration

SOR/2016-230 August 5, 2016

CONTROLLED DRUGS AND SUBSTANCES ACT

Access to Cannabis for Medical Purposes Regulations

P.C. 2016-743 August 5, 2016

Whereas a provision of the annexed Regulations provides for the communication of information obtained under the Regulations to certain classes of persons referred to in paragraph 55(1)(s) of the Controlled Drugs and Substances Act (see footnote a) and, in the opinion of the Governor in Council, it is necessary to communicate that information to those classes of persons for the proper administration or enforcement of the Act and the Regulations;

Therefore, His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 55(1) (see footnote b) of the Controlled Drugs and Substances Act (see footnote c), makes the annexed Access to Cannabis for Medical Purposes Regulations.

TABLE OF PROVISIONS

Access to Cannabis for Medical Purposes Regulations

Interpretation

1 Definitions

2 Equivalency in dried marihuana

Possession

3 Obtaining substance

4 Altering substance

5 Obtaining cannabis — Narcotic Control Regulations

6 Possession limit

Health Care Practitioners

7 Authorized activities

8 Medical document

9 Thirty-day limit

General Provisions

10 Application of Narcotic Control Regulations

11 Further information

12 Police enforcement

13 Alteration of documents

14 Providing assistance in administration of substance

15 Demonstrate authority to possess or produce

16 Prohibition — obtaining from more than one source

PART 1
Commercial Production

Interpretation

17 Definitions

General Provisions

18 Marihuana

19 Cannabis oil

20 Notice of refusal or revocation

21 Inspection of site

DIVISION 1
Licensed Producers

SUBDIVISION A
Authorized Activities and General Obligations

22 Activities

23 Dwelling place

24 Activities — indoors and at site

25 Indoor storage only

26 Identification of licensed producer

27 Responsible person in charge present

28 Safekeeping during transportation

29 Report of loss or theft

30 Destruction

SUBDIVISION B
Licensing

31 Eligible persons

32 Senior person in charge and responsible person in charge

33 Application for licence

34 Security clearance required

35 Issuance of licence

36 Grounds for refusal

37 Period of validity

38 Renewal application

39 Amendment application

40 Notice to Minister — change of personnel

41 Notice to Minister — various changes

42 Statement by signatory of notice

43 Suspension

44 Revocation following suspension

45 Revocation — lost or stolen licence

46 Revocation — other grounds

47 Notice of cessation of activities

48 Notice to local authorities – licence application

49 Notice to local authorities — amendment application

50 Notice to local authorities — various matters

51 Notice to licensing authorities

SUBDIVISION C
Security Measures

General

52 Compliance with security measures

53 Unauthorized access

Perimeter of Site

54 Visual monitoring

55 Intrusion detection system

56 Monitoring by personnel

Areas Within a Site Where Cannabis is Present

57 Restricted access

58 Physical barriers

59 Visual monitoring

60 Intrusion detection system

61 Filtration of air

62 Monitoring by personnel

SUBDIVISION D
Good Production Practices

63 Prohibition — sale, provision or export

64 Microbial and chemical contaminants

65 Disintegration of capsule

66 Pest control product

67 Maximum yield quantity — cannabis oil

68 Solvents

69 Analytical testing

70 Premises

71 Equipment

72 Sanitation program

73 Standard operating procedures

74 Recall

75 Quality assurance

76 Sample of lot or batch

77 Recall reporting

78 Adverse reactions

SUBDIVISION E
Dried Marihuana Equivalency Factor

79 Equivalency factor

SUBDIVISION F
Packaging, Labelling and Shipping

80 Packaging

81 Accuracy of weight

82 Accuracy — number of seeds

83 Accuracy — number of plants

84 Product label — marihuana or cannabis oil

85 Product label – marihuana seeds

86 Product label – marihuana plants

87 Client label

88 Combined label

89 Department of Health document

90 Presentation of information — label

91 Expiry date

92 Reference to Acts or regulations

93 Shipping

SUBDIVISION G
Import and Export

94 Application for import permit

95 Issuance of import permit

96 Refusal to issue import permit

97 Provision of copy of import permit

98 Declaration after release from customs

99 Transportation of imported substance

100 Suspension of import permit

101 Revocation of import permit

102 Application for export permit

103 Issuance of export permit

104 Refusal to issue export permit

105 Provision of copy of export permit

106 Declaration after export

107 Suspension of export permit

108 Revocation of export permit

SUBDIVISION H
Security Clearances

109 Eligibility

110 Application for security clearance

111 Checks

112 Minister’s decision

113 Outstanding criminal charge

114 Refusal to grant security clearance

115 Validity period

116 Security clearance no longer required

117 Suspension of security clearance

118 New applications

119 Sending of notices by Minister

120 False or misleading information

SUBDIVISION I
Communication of Information

121 Information concerning clients

122 Definition of health care practitioner

123 Information concerning health care practitioners

124 Quarterly reports to licensing authorities

125 Information concerning licensed producers

126 Information concerning import or export permit

127 Providing information to foreign organizations

128 Security clearance — Minister

DIVISION 2
Client Registration and Ordering

Registration

129 Eligibility

130 Registration application

131 Health care practitioner’s consent to receive substance

132 Verification of medical document

133 Registration of client

134 Expiry of registration

135 Refusal to register

136 Notice — refusal to register

137 Application to amend registration

138 Amendment

139 Cancellation of registration

140 Prohibition — transfer of document

New Medical Document or Registration Certificate

141 New application – new medical document

142 Applicable provisions

Processing an Order

143 Order required

144 Shipping

145 Refusal

146 Thirty-day limit

147 Return of marihuana plants or seeds

DIVISION 3
Clients and Other Authorized Users

148 Return

DIVISION 4
Sale or Provision by a Licensed Producer to a Person Other than a Client

149 Order required — cannabis

150 Shipping

151 Refusal

DIVISION 5
Record Keeping by Licensed Producers

Transactions

152 Cannabis received

153 Imported substances

154 Exported substances

155 Record of verbal order

156 Filling of order from client

157 Returned substance

158 Order from person other than client

Client Registrations

159 Information

Security, Production and Inventory

160 Security

161 Good production practices and packaging, labelling and shipping

162 Dried marihuana equivalency factor

163 Lot or batch — marihuana

164 Research and development

165 Destroyed cannabis

166 Inventory — marihuana

Notices to Local Authorities

167 Notices

Communications with Licensing Authorities

168 Documents

General Obligations

169 Manner of keeping records

170 Information required by Minister

171 Former licensed producers

PART 2
Production for Own Medical Purposes and Production by a Designated Person

Interpretation

172 Definition

General Provision

173 Signature and attestation

DIVISION 1
Registration with Minister

174 Eligibility – registered person

175 Eligibility — one registration only

176 Eligibility — designated person

177 Registration application

178 Registration

179 Renewal application

180 Renewal

181 Amendment application

182 Amendment

183 Grounds for refusal — registration

184 Grounds for refusal — production for own medical purposes

185 Grounds for refusal — designated person

186 Notice of refusal

DIVISION 2
Production

Authorized Activities

187 Registered person — production for own medical purposes

188 Registered person who has a designated person

189 Designated person

General Provisions

190 Maximum number of plants under production

191 Maximum quantity of dried marihuana in storage

192 Maximum quantity of cannabis in storage

193 Location and type of production

194 Storage at specified site

195 Inspection

DIVISION 3
General Obligations

196 Security

197 Cancellation of registration

198 Notice of cancellation

199 Destruction of cannabis — registered person

200 Destruction of cannabis — designated person

201 Destruction of cannabis — change in production area

202 Communication of information – police

203 Communication of information — licensing authorities

PART 3
Transitional Provisions

254 Definition of Licensed Producers Exemption

255 Licences and permits continued

256 Decisions by Minister

257 Packaging and labelling — dried marihuana

258 Packaging and labelling — fresh marihuana or cannabis oil

259 Sale or provision of marihuana plants or seeds

260 Licence and permit applications

PART 4
Consequential Amendments, Repeal, Application and Coming into Force

Consequential Amendments

261 Narcotic Control Regulations

280 New Classes of Practitioners Regulations

Repeal

281

Application Before Publication

282 Application

Coming into Force

283 August 24, 2016

Access to Cannabis for Medical Purposes Regulations

Interpretation

Definitions

1 (1) The following definitions apply in these Regulations.

Act means the Controlled Drugs and Substances Act. (Loi)

adult means a person who is 18 years of age or older. (adulte)

cannabis means the substance set out in item 1 of Schedule II to the Act. (cannabis ou chanvre indien)

cannabis oil means an oil, in liquid form at room temperature of 22 ± 2°C, that contains cannabis in its natural form. (huile de chanvre indien)

designated person means the individual who is authorized by a registration referred to in section 178 to produce cannabis for the medical purposes of the registered person. (personne désignée)

dried marihuana means harvested marihuana that has been subjected to any drying process, but does not include seeds. (marihuana séchée)

former Marihuana for Medical Purposes Regulations means the regulations made by Order in Council P.C. 2013-645 of June 6, 2013 and registered as SOR/2013-119. (ancien Règlement sur la marihuana à des fins médicales)

former Marihuana Medical Access Regulations means the regulations made by Order in Council P.C. 2001-1146 of June 14, 2001 and registered as SOR/2001-227. (ancien Règlement sur l’accès à la marihuana à des fins médicales)

fresh marihuana means freshly harvested marihuana buds and leaves, but does not include plant material that can be used to propagate marihuana. (marihuana fraîche)

health care practitioner means, except in sections 123, 124 and 203, a medical practitioner or a nurse practitioner. (praticien de la santé)

licensed dealer has the same meaning as in section 2 of the Narcotic Control Regulations. (distributeur autorisé)

licensed producer means the holder of a licence issued under section 35. (producteur autorisé)

marihuana means the substance referred to as “Cannabis (marihuana)” in subitem 1(2) of Schedule II to the Act. (marihuana)

medical document means a medical document referred to in section 8. (document médical)

medical practitioner means a person who

• (a) is registered and entitled under the laws of a province to practise medicine in that province; and
• (b) is not named in a notice issued under section 59 of the Narcotic Control Regulations that has not been retracted under section 60 of those Regulations. (médecin)

nurse practitioner means a nurse practitioner as defined in section 1 of the New Classes of Practitioners Regulations who

• (a) is permitted to prescribe dried marihuana in the province in which they practise; and
• (b) is not named in a notice issued under section 59 of the Narcotic Control Regulations that has not been retracted under section 60 of those Regulations. (infirmier praticien)

registered person means an individual who is registered with the Minister under Part 2. (personne inscrite)

security clearance means a security clearance granted by the Minister under section 112. (habilitation de sécurité)

transfer means, except in sections 140, 144 and 150, to transfer, whether directly or indirectly, without consideration. (transférer)

Destruction

(2) Cannabis is considered to be destroyed when it is altered or denatured to such an extent that its consumption and propagation is rendered impossible or improbable.

Drying

(3) The production of marihuana includes subjecting it to a drying process.

Equivalency in dried marihuana

2 (1) The provisions of this section apply for determining, for the purposes of these Regulations, the quantity of cannabis other than dried marihuana that is equivalent to a given quantity of dried marihuana.

Substances obtained from a licensed producer and products

(2) The quantity of any fresh marihuana or cannabis oil that is obtained from a licensed producer — and the quantity of any products referred to in paragraphs 4(1)(b) and (c) originating from those substances — that is equivalent to a given quantity of dried marihuana must be calculated by

• (a) taking into account the dried marihuana equivalency factor determined under section 79 that the licensed producer has indicated on the label of the fresh marihuana or cannabis oil; and
• (b) in the case of products referred to in paragraphs 4(1)(b) and (c), taking into account the weight of the fresh or dried marihuana — or the volume of the cannabis oil — that was used to make them.

Marihuana produced under Part 2 and products

(3) The quantity of any marihuana that is produced under Part 2 — and the quantity of any products referred to in paragraphs 4(1)(b) and (c) originating from that marihuana — that is equivalent to a given quantity of dried marihuana must be calculated by:

• (a) considering 5 g of fresh marihuana as equivalent to 1 g of dried marihuana; and
• (b) in the case of products referred to in paragraphs 4(1)(b) and (c), taking into account the weight of the fresh or dried marihuana that was used to make them.

Possession

Obtaining substance

3 (1) Subject to the other provisions of these Regulations, a person listed in subsection (2) may possess fresh or dried marihuana or cannabis oil and a person listed in subsection (3) may possess cannabis if the person has obtained it

• (a) in accordance with these Regulations;
• (b) in the course of activities performed in connection with the enforcement or administration of any Act or its regulations;
• (c) from a person who is exempt under section 56 of the Act from the application of subsection 5(1) of the Act with respect to that substance; or
• (d) in the case referred to in subparagraph (2)(a)(iii), under subsection 65(2.1) of the Narcotic Control Regulations.

Fresh or dried marihuana or cannabis oil

(2) The following persons may possess fresh or dried marihuana or cannabis oil:

• (a) a person who has obtained the substance for their own medical purposes or for those of another individual for whom they are responsible
  • (i) from a licensed producer,
  • (ii) from a health care practitioner in the course of treatment for a medical condition, or
  • (iii) from a hospital, under subsection 65(2.1) of the Narcotic Control Regulations;
• (b) a person who requires the substance for the practice of their profession as a health care practitioner in the province in which they have that possession; or
• (c) a hospital employee, if they possess the substance for the purposes of and in connection with their employment.

Cannabis

(3) The following persons may possess cannabis:

• (a) a person who has obtained cannabis for their own medical purposes by producing it as a registered person;
• (b) a person who has obtained cannabis — for their own medical purposes or for those of another individual for whom they are responsible — from a designated person;
• (c) a person who requires cannabis for their business as a licensed producer and who possesses it in accordance with section 22;
• (d) a person who requires cannabis for their business as a licensed dealer;
• (e) a person who is employed as an inspector, an analyst, a peace officer, a member of the Royal Canadian Mounted Police or a member of the technical or scientific staff of a department of the Government of Canada or of the government of a province and who possesses the cannabis for the purposes of and in connection with their employment; or
• (f) a person who is acting as the agent or mandatary of a person whom they have reasonable grounds to believe is a person referred to in paragraph (e) and who possesses the cannabis for the purpose of assisting that person in the administration or enforcement of any Act or its regulations.

Employee or agent or mandatary

(4) A person may possess fresh or dried marihuana or cannabis oil if the person is an employee of or is acting as the agent or mandatary for a person referred to in paragraph (2)(b) or (c), while acting in the course of their employment or their role as agent or mandatary.

Employee or agent or mandatary

(5) A person may possess cannabis if the person is an employee of or is acting as the agent or mandatary for a person referred to in paragraph (3)(c) or (d), while acting in the course of their employment or their role as agent or mandatary.

Altering substance

4 (1) An individual who, in accordance with these Regulations or subsection 65(2.1) of the Narcotic Control Regulations, obtains fresh or dried marihuana or cannabis oil for their own medical purposes or for those of another individual for whom they are responsible, and an individual who, in accordance with these Regulations, produces marihuana for their own medical purposes or those of another person for whom they are the designated person, may alter the chemical or physical properties of

• (a) the fresh or dried marihuana or cannabis oil;
• (b) a product resulting from an alteration of a substance referred to in paragraph (a); or
• (c) a product that is derived from a product referred to in paragraph (b).

No organic solvents

(2) The individual must not use organic solvents when doing those alterations. For the purposes of this subsection, organic solvent means any organic compound that is highly flammable, explosive or toxic, including petroleum naphtha and compressed liquid hydrocarbons such as butane, isobutane, propane and propylene.

Providing substance

(3) An individual who is responsible for another individual may provide a product referred to in subsection (1) only to that individual.

Possession

(4) An individual may possess a product referred to in subsection (1) if they produced it in accordance with this section or obtained it in accordance with these Regulations.

Obtaining cannabis — Narcotic Control Regulations

5 (1) A licensed producer may possess cannabis that they have obtained in accordance with the Narcotic Control Regulations if they require it for their business.

Employee or agent or mandatary

(2) A person may possess cannabis referred to in subsection (1) if the person is an employee of or is acting as the agent or mandatary of the licensed producer, while acting in the course of their employment or their role as agent or mandatary.

Possession limit

6 (1) An individual who possesses products referred to in paragraphs 4(1)(b) and (c), fresh or dried marihuana or cannabis oil — for their own medical purposes or for those of another individual for whom they are responsible — must not possess a total quantity of those products and substances that exceeds the equivalent of the least of the following amounts:

• (a) in the case of substances obtained from a licensed producer or products originating from those substances, 30 times the daily quantity of dried marihuana referred to in paragraph 8(1)(d),
• (b) in the case of marihuana produced in accordance with Part 2 or products originating from it, 30 times the daily quantity of dried marihuana referred to in paragraph 8(1)(d),
• (c) in the case of substances obtained from a hospital by or for an out-patient or products originating from those substances, 30 times the daily quantity of dried marihuana referred to in subparagraph 65.2(c)(iii) of the Narcotic Control Regulations, and
• (d) 150 g of dried marihuana.

Dried marihuana equivalency factor

(2) For the purposes of paragraph (1)(c), the quantity of any products referred to in paragraphs 4(1)(b) and (c), fresh marihuana and cannabis oil must be calculated taking into account the dried marihuana equivalency factor determined under section 79 that the licensed producer has indicated on the label of the fresh marihuana or cannabis oil and, in the case of products described in those paragraphs, also taking into account the weight of the fresh or dried marihuana – or the volume of the cannabis oil – that was used to make them.

Health Care Practitioners

Authorized activities

7 (1) In addition to being authorized to possess fresh or dried marihuana or cannabis oil in accordance with section 3, a health care practitioner may conduct the following activities in regard to a person who is under their professional treatment:

• (a) transfer or administer the substance; or
• (b) provide a medical document.

Transfer

(2) The health care practitioner may also transfer the substance to an individual who is responsible for the person under their professional treatment.

Medical document

8 (1) A medical document provided by a health care practitioner to a person who is under their professional treatment must indicate

• (a) the practitioner’s given name, surname, profession, business address and telephone number, the province in which they are authorized to practise their profession and the number assigned by the province to that authorization and, if applicable, their facsimile number and email address;
• (b) the person’s given name, surname and date of birth;
• (c) the address of the location at which the person consulted with the practitioner;
• (d) the daily quantity of dried marihuana, expressed in grams, that the practitioner authorizes for the person; and
• (e) the period of use.

Period of use

(2) The period of use referred to in paragraph (1)(e)

• (a) must be specified as a number of days, weeks or months, which must not exceed one year; and
• (b) begins on the day on which the medical document is signed by the practitioner.

Validity of medical document

(3) A medical document is valid for the period of use specified in it.

Attestation

(4) The medical document must be signed and dated by the practitioner providing it and must attest that the information in the document is correct and complete.

Thirty-day limit

9 (1) A health care practitioner must not transfer to a person under their professional treatment or an individual who is responsible for that person (both of whom are referred to in this section as the transferee) in a 30-day period a total quantity of fresh marihuana, dried marihuana and cannabis oil that, taking into account the dried marihuana equivalency factor determined under section 79, exceeds the equivalent of 30 times the daily quantity of dried marihuana referred to in paragraph 8(1)(d) that the practitioner has indicated in the medical document on the basis of which the transfer is made.

Definition of 30-day period

(2) In this section, 30-day period means

• (a) the 30-day period beginning on the day on which the practitioner first transfers a substance to the transferee; and
• (b) every 30-day period after the period referred to in paragraph (a).
  

First 30-day period

(3) For the purpose of applying subsection (2), the first 30-day period begins on the day on which the practitioner first transfers a substance to the transferee after the day on which that subsection comes into force, even if the practitioner previously transferred a substance to them.

Additional limit

(4) A health care practitioner must not, at any one time, transfer to the transferee a quantity of the substance that, taking into account the dried marihuana equivalency factor determined under section 79, exceeds the equivalent of 150 g of dried marihuana.

Exclusion

(5) A quantity of the substance that the health care practitioner transfers to the transferee to replace a quantity of the substance that the transferee has returned under section 148 is to be excluded for the purpose of calculating the total quantity referred to in subsection (1).

General Provisions

Application of Narcotic Control Regulations

10 For greater certainty, except in the case of inconsistency with these Regulations, the Narcotic Control Regulations also apply to cannabis referred to in these Regulations.

Further information

11 The Minister may, on receiving an application made under these Regulations, require the submission of any further information that pertains to the information contained in the application and that is necessary for the Minister to process the application.

Police enforcement

12 If, under the Controlled Drugs and Substances Act (Police Enforcement) Regulations, a member of a police force or a person acting under the direction and control of the member is, in respect of the conduct of the member or person, exempt from the application of subsection 4(2) or section 5, 6 or 7 of the Act, the member or person is, in respect of that conduct, exempt from the application of these Regulations.

Alteration of documents

13 It is prohibited to mark, alter or deface a medical document or other document issued under these Regulations.

Providing assistance in administration of substance

14 (1) While in the presence of a person who has obtained fresh or dried marihuana or cannabis oil — or who has produced or obtained a product referred to in paragraph 4(1)(b) or (c) — for their own medical purposes, another person may, for the purpose of providing assistance in the administration of the substance to that person, possess that substance.

Possession limit

(2) The person providing assistance must not possess a total quantity of substances that exceeds the equivalent of

• (a) in the case of fresh or dried marihuana or cannabis oil, the daily quantity of dried marihuana that the other person is authorized to possess, namely the quantity referred to in paragraph 8(1)(d) of these Regulations or subparagraph 65.2(c)(iii) of the Narcotic Control Regulations; or
• (b) in the case of a product referred to in paragraph 4(1)(b) or (c), 5 g of dried marihuana.

Demonstrate authority to possess or produce

15 An individual who, in accordance with these Regulations, possesses or produces fresh or dried marihuana, cannabis oil or marihuana plants or seeds or a product referred to in paragraph 4(1)(b) or (c) must, on demand, demonstrate to a police officer that the possession or production is authorized.

Prohibition — obtaining from more than one source

16 (1) It is prohibited to seek or obtain fresh or dried marihuana, cannabis oil or marihuana plants or seeds from more than one source at a time on the basis of the same medical document.

Exception

(2) However, a registration certificate issued by the Minister under Part 2 on the basis of a medical document may be used to

• (a) obtain an interim supply of fresh or dried marihuana or cannabis oil from a single licensed producer; and
• (b) obtain marihuana plants or seeds from one or more licensed producers.

PART 1

Commercial Production

Interpretation

Definitions

17 (1) The following definitions apply in this Part.

advertisement has the same meaning as in subsection 2(1) of the Narcotic Control Regulations. (annonce)

brand name means, with reference to cannabis, the name, in English or French,

• (a) that is assigned to it;
• (b) that is used to distinguish it; and
• (c) under which it is sold, provided or advertised. (marque nominative)

client means a person who is registered as a client with a licensed producer under section 133. (client)

competent authority has the same meaning as in subsection 2(1) of the Narcotic Control Regulations. (autorité compétente)

delta-9-tetrahydrocannabinol means Δ⁹-tetrahydrocannabinol ((6aR, 10aR)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo [b,d] pyran-1-ol). (delta-9-tétrahydrocannabinol)

hospital has the same meaning as in subsection 2(1) of the Narcotic Control Regulations. (hôpital)

immediate container means the container referred to in section 80. (contenant immédiat)

international obligation means an obligation in respect of cannabis set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres. (obligation internationale)

pest control product has the same meaning as in subsection 2(1) of the Pest Control Products Act. (produit antiparasitaire)

responsible person in charge means, for the purposes of Division 1 of this Part, the person designated under paragraph 32(1)(b). (personne responsable)

Security Directive means the Directive on Physical Security Requirements for Controlled Substances (Security Requirements for Licensed Dealers for the Storage of Controlled Substances) published by the Department of Health, as amended from time to time. (Directive en matière de sécurité)

senior person in charge means the person designated under paragraph 32(1)(a). (responsable principal)

site means

• (a) a building or a place in a building used by a licensed producer; or
• (b) an area occupied exclusively by buildings used by a licensed producer. (installation)

Producer’s site

(2) In this Part, a reference to the site of a licensed producer is a reference to the site specified in the producer’s licence.

General Provisions

Marihuana

18 (1) Marihuana must not be sold or provided under this Part

• (a) with any additives; or
• (b) in any dosage form, such as in a roll or capsule.
  

Definition of additive

(2) For the purposes of paragraph (1)(a), additive means anything other than marihuana but does not include any residue of a pest control product or its components or derivatives unless the amount of the residue exceeds any maximum residue limit specified for the product, component or derivative under section 9 or 10 of the Pest Control Products Act.

Cannabis oil

19 (1) Cannabis oil must not be sold or provided under this Part

• (a) with any additives other than those that are necessary to maintain the product’s quality and stability; or
• (b) in any dosage form other than a capsule or similar dosage form.
  

Definition of additive

(2) For the purposes of paragraph (1)(a), additive does not include any residue of a pest control product or its components or derivatives unless the amount of the residue exceeds any maximum residue limit specified for the product, component or derivative under section 9 or 10 of the Pest Control Products Act.

Notice of refusal or revocation

20 If the Minister proposes to refuse to issue, amend or renew a licence or permit or proposes to revoke a licence or permit, other than in the case of a revocation under section 45 or subsection 47(4), 101(1) or 108(1), the Minister must

• (a) send the applicant or the holder of the licence or permit a notice that sets out the reasons for the refusal or revocation; and
• (b) give the applicant or holder an opportunity to be heard in respect of the refusal or revocation.

Inspection of site

21 In order to confirm any information submitted in support of an application for a licence or an amendment or renewal of a licence, an inspector may, at a time during normal business hours and with the reasonable assistance of the applicant, inspect the site in respect of which the application was made.

DIVISION 1

Licensed Producers

SUBDIVISION A

Authorized Activities and General Obligations

Activities

22 (1) Subject to subsections (2) to (8) and to the other provisions of these Regulations, a licensed producer may

• (a) possess, produce, sell, provide, ship, deliver, transport and destroy marihuana or cannabis oil;
• (b) possess and produce cannabis in its natural form, other than marihuana or cannabis oil, for the purpose of producing cannabis oil, and sell, provide, ship, deliver, transport and destroy that cannabis if it was obtained or produced for that purpose; and
• (c) possess and produce cannabis, other than marihuana or cannabis oil, for the purpose of conducting in vitro testing that is necessary to determine the cannabinoid content of marihuana or cannabis oil, and sell, provide, ship, deliver, transport and destroy that cannabis if it was obtained or produced for that purpose.
  

Cannabis

(2) A licensed producer may sell or provide a substance referred to in subsection (3) to

• (a) another licensed producer;
• (b) a licensed dealer;
• (c) the Minister; or
• (d) a person to whom an exemption relating to the substance has been granted under section 56 of the Act.

Substances

(3) The substances that may be sold or provided under subsection (2) are

• (a) marihuana and cannabis oil;
• (b) cannabis in its natural form, other than marihuana or cannabis oil, that was obtained or produced for the purpose of producing cannabis oil; and
• (c) cannabis, other than marihuana or cannabis oil, that was obtained or produced for the purpose of conducting in vitro testing that is necessary to determine the cannabinoid content of marihuana or cannabis oil.
  

Fresh or dried marihuana or cannabis oil

(4) A licensed producer may

• (a) sell or provide fresh or dried marihuana or cannabis oil to
  • (i) a client of that producer or an individual who is responsible for the client,
  • (ii) a hospital employee, if the possession of the substance is for the purposes of and in connection with their employment, or
  • (iii) a person to whom an exemption relating to the substance has been granted under section 56 of the Act; and
• (b) ship fresh or dried marihuana or cannabis oil to a health care practitioner in the case referred to in subparagraph 130(1)(f)(iii).
  

Registered person

(5) A licensed producer may sell or provide marihuana plants or seeds to a client who is registered with them on the basis of a registration with the Minister made under Part 2 or to an individual who is responsible for the client.

Activities limited

(6) A licensed producer may conduct an activity referred to in subsection (1), (2), (4) or (5) if the producer

• (a) is licensed to conduct the activity; and
• (b) conducts the activity in accordance with their licence.
  

Import

(7) A licensed producer may import marihuana or a substance referred to in paragraph (3)(c) if they do so in accordance with an import permit issued under section 95.

Export

(8) A licensed producer may

• (a) possess marihuana or a substance referred to in paragraph (3)(c) for the purpose of export; and
• (b) export it if they do so in accordance with an export permit issued under section 103.
  

Dwelling place

23 A licensed producer must not conduct any activity referred to in section 22 at a dwelling place.

Activities — indoors and at site

24 A licensed producer must produce, package or label cannabis only indoors and at the producer’s site.

Indoor storage only

25 (1) A licensed producer must store cannabis only indoors and at the producer’s site.

Security Directive

(2) A licensed producer must store cannabis, other than marihuana plants, in accordance with the Security Directive.

Identification of licensed producer

26 A licensed producer must include their name, as set out in their licence, on all the means by which the producer identifies themself in relation to cannabis, including advertising, product labels, orders, shipping documents and invoices.

Responsible person in charge present

27 A licensed producer must not perform a transaction involving cannabis unless the responsible person in charge or, if applicable, the alternate responsible person in charge is physically present at the producer’s site.

Safekeeping during transportation

28 A licensed producer must take any steps that are necessary to ensure the safekeeping of

• (a) cannabis, when shipping, delivering or transporting it; and
• (b) marihuana, cannabis oil or a substance referred to in paragraph 22(3)(c), when transporting it to a port of exit from Canada and when transporting it between the port of entry into Canada and the producer’s site.

Report of loss or theft

29 If a licensed producer experiences a theft of cannabis or an unusual waste or disappearance of cannabis that cannot be explained on the basis of normally accepted business activities, the licensed producer must

• (a) report the occurrence to a member of a police force within 24 hours after becoming aware of it; and
• (b) provide a written report to the Minister within 10 days after becoming aware of the occurrence.

Destruction

30 (1) A licensed producer may destroy cannabis only if they do so

• (a) in accordance with a method that
  • (i) conforms with all federal, provincial and municipal environmental legislation applicable to the location at which it is to be destroyed, and
  • (ii) does not result in any person being exposed to cannabis smoke; and
• (b) in the presence of at least two persons who are qualified to witness the destruction, one of whom must be a person referred to in paragraph (2)(a).

Witness to destruction

(2) The following persons are qualified to witness the destruction of cannabis:

• (a) the senior person in charge, the responsible person in charge and, if applicable, the alternate responsible person in charge; and
• (b) a person who works for or provides services to the licensed producer and acts in a senior position.

Transportation of cannabis

(3) If the cannabis is to be destroyed at a location other than the licensed producer’s site, the senior person in charge, the responsible person in charge or, if applicable, the alternate responsible person in charge must accompany the cannabis to the location at which it is to be destroyed.

SUBDIVISION B

Licensing

Eligible persons

31 The following persons are eligible to apply for a producer’s licence:

• (a) an adult who ordinarily resides in Canada; and
• (b) a corporation that has its head office in Canada or operates a branch office in Canada and whose officers and directors are all adults.

Senior person in charge and responsible person in charge

32 (1) A licensed producer must designate

• (a) one senior person in charge to have overall responsibility for management of the activities conducted by the licensed producer under their licence at their site — who may, if appropriate, be the licensed producer; and
• (b) one responsible person in charge to work at the licensed producer’s site and have responsibility for supervising the activities with respect to cannabis conducted by the licensed producer under their licence at that site and for ensuring that the activities comply with the Act and its regulations and the Food and Drugs Act — who may, if appropriate, be the senior person in charge.
  

Alternate responsible person in charge

(2) A licensed producer may designate one or more alternate responsible persons in charge to work at the licensed producer’s site and have authority to replace the responsible person in charge when that person is absent.

Eligibility

(3) The senior person in charge, the responsible person in charge and, if applicable, the alternate responsible person in charge

• (a) must be adults; and
• (b) must be familiar with the provisions of the Act and its regulations and the Food and Drugs Act that apply to the licence held by the licensed producer by whom they are designated.

Application for licence

33 (1) To apply for a producer’s licence, a person must submit to the Minister an application that contains the following information:

• (a) if the applicant is
  • (i) an individual, the individual’s name, date of birth and gender and any other name registered with a province, under which the individual intends to identify themself or conduct the activities for which the licence is sought (referred to in this section as the proposed activities), or
  • (ii) a corporation, its corporate name and any other name registered with a province, under which it intends to identify itself or conduct the proposed activities, as well as the name, date of birth and gender of each of its officers and directors;
• (b) the address, telephone number and, if applicable, the facsimile number and email address for
  • (i) the site for which the licence is sought (referred to in this section as the proposed site), and
  • (ii) if applicable, each building within the site where the proposed activities are to be conducted;
• (c) the mailing address for the proposed site and, if applicable, for each building referred to in subparagraph (b)(ii), if different from the address provided under paragraph (b);
• (d) the name, date of birth and gender of each of the following persons:
  • (i) the proposed senior person in charge,
  • (ii) the proposed responsible person in charge, and
  • (iii) if applicable, the proposed alternate responsible person in charge;
• (e) the name and gender of each of the persons authorized to place an order for cannabis on behalf of the applicant;
• (f) the activities among those referred to in subsection 22(1) that are proposed to be conducted, the purposes for conducting those activities and the substances in respect of which each of the activities is to be conducted;
• (g) the proposed activities that are to be conducted at each building referred to in subparagraph (b)(ii) and the substances in respect of which each of those activities is to be conducted at each building;
• (h) a detailed description of the security measures at the proposed site, as determined in accordance with the Security Directive and Subdivision C;
• (i) a detailed description of the method that the applicant proposes to use for keeping records, which must permit
  • (i) compliance with the requirements of Division 5,
  • (ii) the Minister to audit the activities of the licensed producer with respect to cannabis, and
  • (iii) the reconciliation of orders for cannabis and shipments and inventories of cannabis;
• (j) if applicable, the maximum quantity (expressed as the net weight in kilograms) of fresh marihuana, dried marihuana, cannabis oil and the substance referred to in paragraph 22(3)(b) to be produced by the applicant under the licence and the production period;
• (k) if applicable, the maximum quantity (expressed as the net weight in kilograms) of fresh marihuana, dried marihuana, cannabis oil and marihuana seeds to be sold or provided by the applicant under the licence under subsections 22(2), (4) and (5) and the period in which that quantity is to be sold or provided; and
• (l) if applicable, the maximum number of marihuana plants to be sold or provided by the applicant under the licence under subsections 22(2) and (5) and the period in which that quantity is to be sold or provided.

Dried marihuana equivalency factor

(2) In the case of an application for a licence to sell or provide fresh marihuana or cannabis oil under subsection 22(4), the applicant must provide the Minister, before commencing to sell or provide the substance, with the dried marihuana equivalency factor determined under section 79 and the method that they used to determine it.

Multiple sites

(3) If the applicant intends to conduct an activity referred to in subsection 22(1) at more than one site, a separate application must be submitted for each proposed site.

Statement by signatory

(4) An application for a producer’s licence must

• (a) be signed and dated by the proposed senior person in charge; and
• (b) include a statement signed and dated by that person indicating that
  • (i) all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and
  • (ii) they have the authority to bind the applicant.
    

Accompanying documents

(5) An application for a producer’s licence must be accompanied by

• (a) a declaration, signed and dated by the proposed senior person in charge, stating that the proposed senior person in charge, the proposed responsible person in charge and, if applicable, the proposed alternate responsible person in charge are familiar with the provisions of the Act and its regulations and the Food and Drugs Act that will apply to the licence;
• (b) if applicable, a copy of any document filed with the province in which the proposed site is located that states the applicant’s name and any other name registered with the province under which the applicant intends to identify themself or conduct the proposed activities;
• (c) if the applicant is a corporation, a copy of the certificate of incorporation or other incorporating instrument;
• (d) a declaration signed and dated by the proposed senior person in charge indicating whether or not the applicant is the owner of the entire proposed site;
• (e) if the proposed site or any portion of it is not owned by the applicant, a declaration signed and dated by the owner of the site or each portion of the site consenting to the use of it by the applicant for the proposed activities;
• (f) a declaration signed and dated by the proposed senior person in charge stating that the proposed site is not a dwelling place;
• (g) a declaration signed and dated by the proposed senior person in charge stating that the notices to local authorities have been provided in accordance with section 48 and specifying the names, titles and addresses of the senior officials to whom they were addressed and the dates on which they were provided, together with a copy of each notice;
• (h) a document signed and dated by the quality assurance person referred to in section 75 that includes
  • (i) a description of the person’s qualifications in respect of the matters referred to in subparagraph 75(1)(a)(ii), and
  • (ii) a report establishing that the buildings, equipment and sanitation program to be used in conducting the proposed activities referred to in Subdivision D comply with the requirements of that Subdivision; and
• (i) floor plans for the proposed site.

Security clearance required

34 The following persons must hold a security clearance:

• (a) the senior person in charge;
• (b) the responsible person in charge;
• (c) if applicable, the alternate responsible person in charge;
• (d) if a producer’s licence is issued to an individual, that individual; and
• (e) if a producer’s licence is issued to a corporation, each officer and director of the corporation.
  

Issuance of licence

35 Subject to section 36, the Minister must, after examining the information and documents required under section 33 and, if applicable, section 11, and after all of the security clearances required by section 34 have been granted under section 112, issue to the applicant a producer’s licence that indicates

• (a) the licence number;
• (b) the name of the licence holder;
• (c) the list of authorized activities;
• (d) the address of the site and, if applicable, of each building within the site where the licensed producer may conduct the authorized activities;
• (e) in respect of each building, the authorized activities that may be conducted at that building and, in respect of each activity, the substances in respect of which the activity may be conducted;
• (f) the security level, determined in accordance with the Security Directive, of each location within the site where cannabis, other than marihuana plants, is stored;
• (g) the effective date of the licence;
• (h) the expiry date of the licence, which must not be later than three years after its effective date;
• (i) if applicable, the maximum quantity (expressed as the net weight in kilograms) of fresh marihuana, dried marihuana, cannabis oil and the substance referred to in paragraph 22(3)(b) that may be produced under the licence in a specified period;
• (j) if applicable, the maximum quantity (expressed as the net weight in kilograms) of fresh marihuana, dried marihuana, cannabis oil and marihuana seeds that may be sold or provided under the licence in a specified period in accordance with subsections 22(2), (4) and (5);
• (k) if applicable, the maximum number of marihuana plants that may be sold or provided under the licence in a specified period in accordance with subsections 22(2) and (5); and
• (l) if applicable, any conditions that the licence holder must meet in order to
  • (i) comply with an international obligation,
  • (ii) provide the security level referred to in paragraph (f),
  • (iii) put in place the security measures referred to in Subdivision C, or
  • (iv) reduce any potential public health, safety or security risk, including the risk of cannabis being diverted to an illicit market or use.
    

Grounds for refusal

36 (1) The Minister must refuse to issue, renew or amend a producer’s licence in the following circumstances:

• (a) the applicant is not eligible under section 31;
• (b) the requirements of section 48 or 49 have not been met;
• (c) an inspector, who has requested an inspection, has not been given the opportunity by the applicant to conduct an inspection under section 21;
• (d) the Minister has reasonable grounds to believe that false or misleading information was submitted in, or false or falsified documents were submitted with, the application;
• (e) information received from a peace officer, a competent authority or the United Nations raises reasonable grounds to believe that the applicant has been involved in the diversion of a controlled substance or precursor to an illicit market or use;
• (f) the applicant does not have in place the security measures set out in the Security Directive and Subdivision C in respect of an activity for which the licence is sought;
• (g) the applicant is in contravention of or has contravened in the past 10 years
  • (i) a provision of the Act or its regulations or the Food and Drugs Act, or
  • (ii) a term or condition of another licence or a permit issued to it under any of those regulations;
• (h) the issuance, renewal or amendment of the licence would likely create a risk to public health, safety or security, including the risk of cannabis being diverted to an illicit market or use;
• (i) any of the following persons does not hold a security clearance:
  • (i) the senior person in charge,
  • (ii) the responsible person in charge,
  • (iii) if applicable, the alternate responsible person in charge,
  • (iv) if the applicant is an individual, that individual, and
  • (v) if the applicant is a corporation, any of its officers or directors;
• (j) the proposed method of record keeping does not meet the requirements of paragraph 33(1)(i); or
• (k) if applicable, the information required under section 11 has not been provided or is insufficient to process the application.
  

Exception

(2) Unless it is necessary to do so to protect public health, safety or security, including preventing cannabis from being diverted to an illicit market or use, the Minister must not refuse to issue, renew or amend a licence under paragraph (1)(d) or (g) if the applicant has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and its regulations and the Food and Drugs Act.

Failure to comply with undertaking

(3) If an applicant fails to comply with an undertaking referred to in subsection (2), the Minister must refuse to issue, renew or amend the licence.

Period of validity

37 A producer’s licence is valid until the earlier of

• (a) the expiry date of the licence, and
• (b) the date on which the licence is revoked under any of sections 44 to 47.
  

Renewal application

38 (1) To apply to renew their licence, a licensed producer must submit to the Minister an application that contains the following:

• (a) the original of the licence; and
• (b) a declaration signed and dated by the senior person in charge stating that as of the date of the application
  • (i) that person has the authority to bind the applicant, and
  • (ii) to the best of that person’s knowledge,
    • (A) the information shown on the producer’s licence as specified in paragraphs 35(a) to (f ) and (i) to (l) is correct and complete, and
    • (B) if applicable, the requirements of sections 40 and 41 have been met.

Renewal

(2) Subject to section 36, the Minister must, after examining the information and documents required under subsection (1) and, if applicable, section 11, issue a renewed licence that contains the information set out in paragraphs 35(a) to (l).

Simultaneous processing of applications

(3) If a licensed producer submits an application under section 39 or paragraph 40(1)(a) together with an application under subsection (1), the Minister may process them together.

Amendment application

39 (1) A licensed producer proposing to amend the content of their licence must provide the Minister with the following documents:

• (a) an application in writing describing the proposed amendment, as well as any information or documents mentioned in section 33 that are relevant to the proposed amendment;
• (b) if applicable, a declaration signed and dated by the senior person in charge stating that the notices to local authorities have been provided in accordance with section 49 and specifying the names, titles and addresses of the senior officials to whom they were addressed and the dates on which they were provided, together with a copy of each notice; and
• (c) the original of the licence.

Statement by signatory

(2) The application must

• (a) be signed and dated by the senior person in charge; and
• (b) include a statement signed and dated by that person indicating that
  • (i) all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and
  • (ii) they have the authority to bind the applicant.

Issuance

(3) Subject to section 36, the Minister must, after examining the information and documents required under this section and, if applicable, section 11, amend the licence accordingly and may add any conditions that the licence holder must meet in order to

• (a) comply with an international obligation;
• (b) provide the security level referred to in paragraph 35(f) or the new level applicable as a result of the amendment of the licence;
• (c) put in place the security measures referred to in Subdivision C; or
• (d) reduce any potential public health, safety or security risk, including the risk of cannabis being diverted to an illicit market or use.
  

Notice to Minister — change of personnel

40 (1) A licensed producer must

• (a) apply for and obtain the Minister’s approval before making a change involving the replacement or the addition of
  • (i) the senior person in charge,
  • (ii) the responsible person in charge and, if applicable, the alternate responsible person in charge,
  • (iii) if applicable, an officer or director referred to in subparagraph 33(1)(a)(ii), or
  • (iv) an individual authorized to place an order for cannabis on behalf of the licensed producer;
• (b) except in the case referred to in subsection (3), notify the Minister, not later than five days after the event, when a person referred to in any of subparagraphs (a)(i), (ii) and (iv) ceases to carry out their duties; and
• (c) notify the Minister, not later than five days after the event, when a person referred to in subparagraph (a)(iii) ceases to be an officer or director.
  

Accompanying information

(2) The licensed producer must, with the application for approval referred to in paragraph (1)(a), provide the Minister with the following information and documents with respect to the new person:

• (a) in the case of the replacement of the senior person in charge or the responsible person in charge or the replacement or addition of an alternate responsible person in charge,
  • (i) the information specified in paragraph 33(1)(d), and
  • (ii) the declaration specified in paragraph 33(5)(a);
• (b) in the case of the replacement or addition of an officer or director, the information specified in subparagraph 33(1)(a)(ii) concerning that person; and
• (c) in the case of the replacement or addition of an individual who is authorized to place an order for cannabis on behalf of the licensed producer, the information specified in paragraph 33(1)(e).

Notice to Minister — responsible person in charge

(3) A licensed producer must notify the Minister not later than the next business day if the responsible person in charge ceases to carry out their duties and there is no person designated as an alternate responsible person in charge.

Notice to Minister — various changes

41 (1) A licensed producer must, within five days after the change, notify the Minister of any change to

• (a) the method used for keeping records;
• (b) the telephone number and, if applicable, the facsimile number and email address for
  • (i) their site; and
  • (ii) if applicable, each building within the site where the activities are conducted under the licence; or
• (c) the security of their site, other than a change that affects the security level of any location within the site where cannabis, other than marihuana plants, is stored.
  

Dried marihuana equivalency factor

(2) A licensed producer must provide the Minister with any new dried marihuana equivalency factor determined under section 79, and the method used to determine it, at least 10 days before selling or providing, under subsection 22(4), fresh marihuana or cannabis oil in respect of which the label referred to in section 84 or 88 indicates the new factor.

Statement by signatory of notice

42 An application or notification made under section 40 or 41, respectively, must

• (a) be signed and dated by the senior person in charge; and
• (b) include a statement signed and dated by that person indicating that
  • (i) all information and, if applicable, documents submitted in support of the application or notification are correct and complete to the best of their knowledge, and
  • (ii) they have the authority to bind the licensed producer.

Suspension

43 (1) The Minister must suspend a producer’s licence without prior notice in respect of any or all activities or substances set out in the licence if the Minister has reasonable grounds to believe that it is necessary to do so to protect public health, safety or security, including preventing cannabis from being diverted to an illicit market or use.

Notice of suspension

(2) The suspension takes effect as soon as the Minister notifies the licensed producer of the decision to suspend and provides a written report that sets out the reasons for the suspension.

Opportunity to be heard

(3) The licensed producer may, within 10 days after receipt of the notice, provide the Minister with reasons why the suspension is unfounded.

Ceasing of suspended activities

(4) If a licence is suspended in respect of any or all activities or substances set out in the licence, the licensed producer must cease conducting those activities with respect to those substances for the duration of the suspension.

Reinstatement of licence

(5) The Minister must, by notice to the licensed producer, reinstate a licence, in respect of any or all activities or substances affected by the suspension, if the licensed producer demonstrates to the Minister that

• (a) the failure that gave rise to the suspension has been rectified; or
• (b) the suspension was unfounded.

Revocation following suspension

44 The Minister must revoke a licence if the licensed producer fails to comply with the decision of the Minister to suspend the licence under section 43 or if the failure that gave rise to the suspension is not rectified.

Revocation — lost or stolen licence

45 The Minister must revoke a producer’s licence on being notified by the licensed producer that the licence has been lost or stolen.

Revocation — other grounds

46 (1) Subject to subsection (2), the Minister must revoke a producer’s licence in the following circumstances:

• (a) the Minister has reasonable grounds to believe that the licence was issued on the basis of false or misleading information submitted in, or false or falsified documents submitted with, the application;
• (b) the licensed producer has, since the issuance of the licence, contravened a provision of the Act or its regulations or the Food and Drugs Act or a condition of their licence or of an import or export permit issued under this Part;
• (c) the licensed producer is no longer eligible under section 31;
• (d) information received from a peace officer, a competent authority or the United Nations raises reasonable grounds to believe that the licensed producer has been involved in the diversion of a controlled substance or precursor to an illicit market or use; or
• (e) any of the persons referred to in section 34 does not hold a security clearance.
  

Exceptions

(2) Unless it is necessary to do so to protect public health, safety or security, including preventing cannabis from being diverted to an illicit market or use, the Minister must not revoke a producer’s licence in the circumstances described in paragraph (1)(a) or (b) if the licensed producer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and its regulations and the Food and Drugs Act.

Failure to comply with undertaking

(3) If the licensed producer fails to comply with an undertaking referred to in subsection (2), the Minister must revoke the licence.

Notice of cessation of activities

47 (1) A licensed producer who intends to cease conducting activities at their site — whether before or on the expiry of their licence — must submit to the Minister a written notice to that effect at least 30 days before ceasing those activities.

Content of notice

(2) The notice must be signed and dated by the senior person in charge and contain the following information:

• (a) the expected date of the cessation of activities at the site;
• (b) a description of the manner in which any cannabis remaining on the site as of the date referred to in paragraph (a) will be dealt with by the licensed producer, including
  • (i) if some or all of it will be sold or provided to another licensed producer who will be conducting activities at the same site, the name of that producer,
  • (ii) if some or all of it will be sold or provided to another licensed producer or a licensed dealer, the name of that producer and the address of their site or the name of that dealer and the address of their premises, and
  • (iii) if some or all of it will be destroyed, the date on which and the location at which the destruction is to take place;
• (c) the address of the location at which the licensed producer’s records, books, electronic data and other documents will be kept after activities have ceased; and
• (d) the name, address, telephone number and, if applicable, the facsimile number and email address of a person whom the Minister may contact for further information after activities have ceased.

Update

(3) After having ceased the activities, the licensed producer must submit to the Minister a detailed update of the information referred to in paragraphs (2)(a) to (d), if it differs from what was set out in the notice submitted under subsection (1). The update must be signed and dated by the senior person in charge.

Return and revocation of licence

(4) If the activities cease before the expiry of the licence, the licensed producer must return to the Minister the original of the licence. The Minister must then revoke the licence.

Notice to local authorities – licence application

48 (1) Before submitting an application for a producer’s licence to the Minister under section 33, the applicant must provide a written notice to the following authorities in the area in which the site referred to in paragraph 33(1)(b) is located:

• (a) the local government;
• (b) the local fire authority; and
• (c) the local police force or the Royal Canadian Mounted Police detachment that is responsible for providing policing services to that area.

Content of notice

(2) The notice must contain the following information:

• (a) the name of the applicant;
• (b) the date on which the applicant will submit the application to the Minister;
• (c) the activities referred to in subsection 22(1) for which the licence is to be sought, specifying that they are to be conducted in respect of cannabis; and
• (d) the address of the site and, if applicable, of each building within the site where the applicant proposes to conduct those activities.
  

Senior official

(3) The notice must be addressed to a senior official of the local authority to whom it is provided.

Definition — local government

(4) In this section, local government includes

• (a) an incorporated or unincorporated city, metropolitan area, town, village or municipality;
• (b) a band, as defined in subsection 2(1) of the Indian Act; and
• (c) a band that is a party to a comprehensive self-government agreement given effect by an Act of Parliament.
  

Notice to local authorities — amendment application

49 (1) Before submitting a licence amendment application to the Minister under section 39 concerning a change referred to in subsection (2), a licensed producer must provide a written notice to the authorities referred to in paragraphs 48(1)(a) to (c) in the area in which the site to be specified in the amended licence is located.

Applicable changes

(2) Subsection (1) applies in respect of an application to amend a licence to change

• (a) the name of the licensed producer;
• (b) the activities to be conducted by the producer under the licence; or
• (c) the address of the site and, if applicable, of each building within the site where those activities are to be conducted.

Content of notice

(3) The notice must contain the following information:

• (a) the name of the licensed producer and, if applicable, the proposed new name of the producer;
• (b) the date on which the producer will submit the application to the Minister;
• (c) the activities referred to in subsection 22(1) that are to be set out in the amended licence, specifying that they are to be conducted in respect of cannabis; and
• (d) the address of the site and, if applicable, of each building within the site that is to be set out in the amended licence.
  

Senior official

(4) The notice must be addressed to a senior official of the local authority to whom it is provided.

Notice to local authorities — various matters

50 (1) Within 30 days after the issuance, renewal, amendment, suspension, reinstatement or revocation of its licence, a licensed producer must provide a written notice to the local authorities referred to in paragraphs 48(1)(a) to (c) in the area in which the site specified in the licence is located and provide a copy of the notice to the Minister.

Content of notice

(2) The notice must contain the following information:

• (a) the name of the licensed producer and the address of their site; and
• (b) a description of the applicable event referred to in subsection (1) and its effective date and, in the case of an amendment to the licence, details of the amendment.

Senior official

(3) The notice must be addressed to a senior official of the local authority to whom it is provided.

Notice to licensing authorities

51 (1) Within 30 days after the issuance of its licence, a licensed producer must provide a written notice to each licensing authority that is responsible for the registration or authorization of persons to practise medicine or nursing in each province and provide a copy of the notice to the Minister.

Content of notice

(2) The notice must contain the following information:

• (a) the name of the licensed producer, the mailing address of their site and, if applicable, their email address; and
• (b) the effective date of the licence.

SUBDIVISION C

Security Measures

General

Compliance with security measures

52 A licensed producer must ensure that the security measures set out in this Subdivision are carried out.

Unauthorized access

53 The licensed producer’s site must be designed in a manner that prevents unauthorized access.

Perimeter of Site

Visual monitoring

54 (1) The perimeter of the licensed producer’s site must be visually monitored at all times by visual recording devices to detect any attempted or actual unauthorized access.

Visual recording devices

(2) The devices must, in the conditions under which they are used, be capable of making a visible recording of any attempted or actual unauthorized access.

Intrusion detection system

55 The perimeter of the licensed producer’s site must be secured by means of an intrusion detection system that operates at all times and that allows for the detection of any attempted or actual unauthorized access to or movement in the site or tampering with the system.

Monitoring by personnel

56 (1) The intrusion detection system must be monitored at all times by personnel who must determine the appropriate steps to be taken in response to the detection of any occurrence referred to in section 54 or 55.

Record of detected occurrences

(2) If any such occurrence is detected, the personnel must make a record of

• (a) the date and time of the occurrence; and
• (b) the measures taken in response to it and the date and time when they were taken.
  

Areas Within a Site Where Cannabis is Present

Restricted access

57 (1) Access to areas within a site where cannabis is present (referred to in this section and sections 58 to 61 as those areas) must be restricted to persons whose presence in those areas is required by their work responsibilities.

Responsible person in charge present

(2) The responsible person in charge or, if applicable, the alternate responsible person in charge must be physically present while other persons are in those areas.

Record

(3) A record must be made of the identity of every person entering or exiting those areas.

Physical barriers

58 Those areas must include physical barriers that prevent unauthorized access.

Visual monitoring

59 (1) Those areas must be visually monitored at all times by visual recording devices to detect illicit conduct.

Visual recording devices

(2) The devices must, in the conditions under which they are used, be capable of making a visible recording of illicit conduct.

Intrusion detection system

60 Those areas must be secured by means of an intrusion detection system that operates at all times and that allows for the detection of any attempted or actual unauthorized access to or movement in those areas or tampering with the system.

Filtration of air

61 Those areas must be equipped with a system that filters air to prevent the escape of odours and, if present, pollen.

Monitoring by personnel

62 (1) The intrusion detection system must be monitored at all times by personnel who must determine the appropriate steps to be taken in response to the detection of any occurrence referred to in section 59 or 60.

Record of detected occurrences

(2) If any such occurrence is detected, the personnel must make a record of

• (a) the date and time of the occurrence; and
• (b) the measures taken in response to it and the date and time when they were taken.
  

SUBDIVISION D

Good Production Practices

Prohibition — sale, provision or export

63 (1) A licensed producer must not sell or provide fresh or dried marihuana, cannabis oil or marihuana plants or seeds under subsection 22(4) or (5) or export them, if applicable, unless the applicable requirements of this Subdivision have been met.

Research and development activity

(2) A licensed producer must not sell or provide those substances under subsection 22(4) or (5) if they have been used in research and development activity.

Microbial and chemical contaminants

64 The microbial and chemical contaminants of fresh or dried marihuana or cannabis oil must be within generally accepted tolerance limits for herbal medicines for human consumption, as established in any publication referred to in Schedule B to the Food and Drugs Act.

Disintegration of capsule

65 A capsule or similar dosage form of cannabis oil that is intended to be swallowed whole or used as a suppository must meet the requirements of a disintegration test that is applicable to the formulation of the capsule or similar dosage form and that is set out in any publication referred to in Schedule B to the Food and Drugs Act.

Pest control product

66 Fresh or dried marihuana or marihuana plants or seeds must not be treated with a pest control product unless the product is registered for use on marihuana under the Pest Control Products Act or is otherwise authorized for use under that Act.

Maximum yield quantity — cannabis oil

67 (1) Cannabis oil must not exceed a maximum yield quantity of 30 mg of delta-9-tetrahydrocannabinol per millilitre of the oil in the immediate container, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol.

Capsule or other dosage form

(2) If cannabis oil is in a capsule or similar dosage form, each capsule or unit of the dosage form must not exceed a maximum yield quantity of 10 mg of delta-9-tetrahydrocannabinol, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol.

Solvents

68 (1) Cannabis oil must not contain residues of solvents other than Class 3 solvents listed in the Guidance Document — Impurities: Guideline for Residual Solvents, ICH Topic Q3C(R5), published by the Department of Health, as amended from time to time.

Residue limit

(2) Those residues must not exceed the limits established under that document.

Non-application of section 64

(3) Section 64 does not apply with respect to those residues.

Analytical testing

69 Analytical testing for the following must be conducted using validated methods:

• (a) the contaminants referred to in section 64;
• (b) the disintegration referred to in section 65;
• (c) the residues of solvents referred to in section 68; and
• (d) the content of delta-9-tetrahydrocannabinol, delta-9-tetrahydrocannabinolic acid, cannabidiol and cannabidiolic acid.

Premises

70 (1) Fresh or dried marihuana, cannabis oil or marihuana plants or seeds must be produced, packaged, labelled and stored in premises that are designed, constructed and maintained in a manner that permits those activities to be conducted under sanitary conditions, and in particular that

• (a) permits the premises to be kept clean and orderly;
• (b) permits the effective cleaning of all surfaces in the premises;
• (c) permits the substance to be stored or processed appropriately;
• (d) prevents the contamination of the substance; and
• (e) prevents the addition of an extraneous substance to the substance.
  

Storage

(2) Those substances must be stored under conditions that will maintain their quality.

Equipment

71 Fresh or dried marihuana, cannabis oil or marihuana plants or seeds must be produced, packaged, labelled and stored using equipment that is designed, constructed, maintained, operated and arranged in a manner that

• (a) permits the effective cleaning of its surfaces;
• (b) permits it to function in accordance with its intended use;
• (c) prevents the contamination of the substance; and
• (d) prevents the addition of an extraneous substance to the substance.

Sanitation program

72 Fresh or dried marihuana, cannabis oil or marihuana plants or seeds must be produced, packaged, labelled and stored in accordance with a sanitation program that sets out

• (a) procedures for effectively cleaning the premises in which those activities are conducted;
• (b) procedures for effectively cleaning the equipment used in those activities;
• (c) procedures for handling any substance used in those activities; and
• (d) all requirements, in respect of the health, hygienic behaviour and clothing of the personnel who are involved in those activities, that are necessary to ensure that those activities are conducted in sanitary conditions.

Standard operating procedures

73 Fresh or dried marihuana, cannabis oil or marihuana plants or seeds must be produced, packaged, labelled and stored in accordance with standard operating procedures that are designed to ensure that those activities are conducted in accordance with the requirements of this Subdivision.

Recall

74 A licensed producer must establish and maintain a system of control that permits the rapid and complete recall of every lot or batch of fresh or dried marihuana, cannabis oil or marihuana plants or seeds that has been made available for sale.

Quality assurance

75 (1) A licensed producer must

• (a) have a quality assurance person who
  • (i) is responsible for assuring the quality of the fresh or dried marihuana, cannabis oil or marihuana plants or seeds before they are made available for sale, and
  • (ii) has the training, experience and technical knowledge relating to the activity conducted and the requirements of this Subdivision; and
• (b) investigate every complaint received in respect of the quality of those substances and, if necessary, take corrective and preventative measures.
  

Methods and procedures

(2) Those substances must be produced, packaged, labelled and stored using methods and procedures that, prior to their implementation, have been approved by a quality assurance person.

Approval prior to sale

(3) Every lot or batch of those substances must be approved by a quality assurance person before it is made available for sale.

Returns

(4) Any of those substances that is sold or provided under subsection 22(4) or (5) and subsequently returned to the licensed producer must not be resold or provided again.

Sample of lot or batch

76 (1) Subject to subsection (3), if the Minister has reasonable grounds to believe that a lot or batch of fresh or dried marihuana, cannabis oil or marihuana plants or seeds made available for sale or provision by a licensed producer may — by reason of the manner in which the substance was produced, packaged, labelled or stored — pose a risk to the health of a person who obtains the substance for their own medical purposes, the Minister may require the licensed producer to provide the Minister with a sample of that lot or batch.

Quantity

(2) The sample must be of sufficient quantity to enable a determination of whether the lot or batch meets the requirements of sections 64 and 66 and, if applicable, sections 65, 67 and 68.

Period

(3) The Minister must not require a sample to be provided if more than one year has elapsed after the date of the last sale or provision of any portion of the lot or batch.

Recall reporting

77 Before commencing a recall of fresh or dried marihuana, cannabis oil or marihuana plants or seeds, a licensed producer must provide the Minister with the following information in respect of the substance to be recalled:

• (a) its brand name;
• (b) the number of each lot or batch to be recalled;
• (c) if known by the licensed producer, the name and address of each licensed producer who imported or produced any of it;
• (d) the reasons for commencing the recall;
• (e) the quantity that was produced or imported into Canada by the licensed producer;
• (f) the quantity that was sold or provided in Canada by the licensed producer;
• (g) the quantity remaining in the possession of the licensed producer;
• (h) the number of persons referred to in subsections 22(2), (4) and (5) to whom it was sold or provided by the licensed producer; and
• (i) a description of any other action that the licensed producer is taking in respect of the recall.

Adverse reactions

78 (1) A licensed producer who sells or provides fresh or dried marihuana or cannabis oil must provide the Minister with a case report for each serious adverse reaction to the substance, within 15 days after the day on which the producer becomes aware of the reaction.

Summary report

(2) A licensed producer who sells or provides fresh or dried marihuana or cannabis oil must prepare annually and maintain a summary report that contains a concise and critical analysis of all adverse reactions to the substance that have occurred during the previous 12 months.

Provide Minister with report on request

(3) If, after reviewing a case report provided under subsection (1) or after reviewing any other safety data relating to the fresh or dried marihuana or cannabis oil, the Minister has reasonable grounds to believe that it may — by reason of the manner in which it was produced, packaged, labelled or stored — pose a risk to the health of a person who in accordance with these Regulations obtains it for their own medical purposes, the Minister may request that, within 30 days after the day on which the request is received, the licensed producer

• (a) provide the Minister with a copy of any summary report prepared under subsection (2); or
• (b) prepare and provide the Minister with an interim summary report containing a concise and critical analysis of all adverse reactions to the substance that have occurred since the date of the most recent summary report prepared under subsection (2).

Definitions

(4) The following definitions apply in this section.

adverse reaction means a noxious and unintended response to fresh or dried marihuana or cannabis oil. (réaction indésirable)

case report means a detailed record of all relevant data associated with the use of fresh or dried marihuana or cannabis oil by a person. (fiche d’observation)

serious adverse reaction means a noxious and unintended response to fresh or dried marihuana or cannabis oil that requires in-patient hospitalization or a prolongation of existing hospitalization, that causes congenital malformation, that results in persistent or significant disability or incapacity, that is life threatening or that results in death. (réaction indésirable grave)

SUBDIVISION E

Dried Marihuana Equivalency Factor

Equivalency factor

79 (1) A licensed producer who sells or provides fresh marihuana or cannabis oil under subsection 22(4) must determine the quantity of the marihuana or oil that is equivalent to one gram of dried marihuana.

Information

(2) The information about the dried marihuana equivalency factor must be made available on the licensed producer’s website and be provided on request.

SUBDIVISION F

Packaging, Labelling and Shipping

Packaging

80 (1) A licensed producer who sells or provides fresh or dried marihuana or cannabis oil under subsection 22(4) must ensure that

• (a) the substance is packaged in an immediate container
  • (i) that is in direct contact with the substance or, in the case of a substance in a capsule or similar dosage form, that is in direct contact with the capsules or units of that dosage form,
  • (ii) that prevents the contamination of the substance and, in the case of dried marihuana, keeps it dry,
  • (iii) that has a security feature that provides reasonable assurance to consumers that the container has not been opened prior to receipt, and
  • (iv) that is a child resistant package that meets the requirements of subsections C.01.001(2) to (4) of the Food and Drug Regulations; and
• (b) not more than the equivalent of 30 g of dried marihuana is in the immediate container.
  

Marihuana seeds

(2) A licensed producer who sells or provides marihuana seeds under subsection 22(5) must ensure that they are packaged in an immediate container that

• (a) is in direct contact with the seeds;
• (b) keeps them dry and prevents their contamination; and
• (c) has a security feature that provides reasonable assurance to consumers that the container has not been opened prior to receipt.

Marihuana plants

(3) A licensed producer who sells or provides marihuana plants under subsection 22(5) must ensure that they are sold or provided in a package that has a security feature that provides reasonable assurance to consumers that the package has not been opened prior to receipt.

Accuracy of weight

81 (1) A licensed producer who sells or provides fresh or dried marihuana or cannabis oil under subsection 22(4) must ensure that the net weight of the substance in the immediate container is not less than 95% and not more than 105% of the net weight specified on the label in accordance with section 84.

Accuracy of volume

(2) A licensed producer who sells or provides cannabis oil under subsection 22(4) must ensure that the net volume of the oil in the immediate container is not less than 95% and not more than 105% of the net volume specified on the label in accordance with section 84.

Accuracy — number of capsules or units

(3) A licensed producer who sells or provides cannabis oil under subsection 22(4) in a capsule or similar dosage form must ensure that number of capsules or units in the container is the same as the number specified on the label in accordance with section 84.

Accuracy — number of seeds

82 A licensed producer who sells or provides marihuana seeds under subsection 22(5) must ensure that the number of seeds in the immediate container is the same as the number specified on the label in accordance with section 85.

Accuracy — number of plants

83 A licensed producer who sells or provides marihuana plants under subsection 22(5) must ensure that the exact number of plants in the package referred to in subsection 80(3) is indicated on the package.

Product label — marihuana or cannabis oil

84 (1) A licensed producer who sells or provides fresh or dried marihuana or cannabis oil under subsection 22(4) must ensure that a label that contains the following information and the information set out in subsection (2), (3) or (4), as applicable, is affixed to the immediate container:

• (a) the name, telephone number and email address of the licensed producer;
• (b) the words “Fresh marihuana / Marihuana fraîche”, “Dried marihuana / Marihuana séchée” or “Cannabis oil / Huile de chanvre indien” (or the equivalent term “Cannabis oil / Huile de cannabis”), as applicable;
• (c) in respect of the substance in the container,
  • (i) its brand name,
  • (ii) its lot number, preceded by one of the following designations:
    • (A) “Lot number”,
    • (B) “Lot no.”,
    • (C) “Lot”, or
    • (D) “(L)”,
  • (iii) its recommended storage conditions,
  • (iv) its packaging date, and
  • (v) either
    • (A) its expiry date established in accordance with section 91, or
    • (B) a statement that no expiry date has been determined;
• (d) the symbol “N” set out in the upper left quarter of the label in a colour contrasting with the rest of the label or in type not less than half the size of any other letters used on the label;
• (e) the warning “KEEP OUT OF REACH OF CHILDREN / TENIR HORS DE LA PORTÉE DES ENFANTS”; and
• (f) the statement “Important: Please read the Health Canada document provided with this package before using this product. / Important : Veuillez lire le document de Santé Canada qui accompagne ce colis avant d’utiliser ce produit.”.
  

Fresh or dried marihuana

(2) In the case of fresh or dried marihuana, the label must also contain the following information in respect of the marihuana in the container:

• (a) its net weight in grams;
• (b) the percentage of delta-9-tetrahydrocannabinol w/w, followed by the word “delta-9-tetrahydrocannabinol”;
• (c) the percentage of delta-9-tetrahydrocannabinol w/w that the marihuana could yield, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol;
• (d) the percentage of cannabidiol w/w, followed by the word “cannabidiol”;
• (e) the percentage of cannabidiol w/w that the marihuana could yield, taking into account the potential to convert cannabidiolic acid into cannabidiol; and
• (f) in the case of fresh marihuana, the dried marihuana equivalency factor determined under section 79.
  

Oil other than in dosage form

(3) In the case of cannabis oil that is not sold in a capsule or similar dosage form, the label must also contain the following information in respect of the oil in the container:

• (a) its net weight in grams;
• (b) its net volume in millilitres;
• (c) the quantity of delta-9-tetrahydrocannabinol, in milligrams per millilitre;
• (d) the quantity of delta-9-tetrahydrocannabinol, in milligrams per millilitre, that the oil could yield, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol;
• (e) the quantity of cannabidiol, in milligrams per millilitre;
• (f) the quantity of cannabidiol, in milligrams per millilitre, that the oil could yield, taking into account the potential to convert cannabidiolic acid into cannabidiol;
• (g) the dried marihuana equivalency factor determined under section 79;
• (h) the carrier oil used;
• (i) the name of any food allergen, within the meaning of subsection B.01.010.1(1) of the Food and Drug Regulations, that is contained in the oil; and
• (j) in the case of cannabis oil that is intended for topical use only, the warning “FOR TOPICAL USE ONLY. DO NOT INGEST. / POUR USAGE TOPIQUE SEULEMENT. NE PAS INGÉRER.”.

Oil in dosage form

(4) In the case of cannabis oil that is sold in a capsule or similar dosage form, the label must also contain the following information in respect of the oil in the container:

• (a) the number of capsules or units of that dosage form;
• (b) the net weight in grams as well as the net volume in millilitres of each capsule or unit;
• (c) the quantity of delta-9-tetrahydrocannabinol, in milligrams, in each capsule or unit;
• (d) the quantity of delta-9-tetrahydrocannabinol, in milligrams, that each capsule or unit could yield, taking into account the potential to convert delta-9-tetrahydrocannabinolic acid into delta-9-tetrahydrocannabinol;
• (e) the quantity of cannabidiol, in milligrams, in each capsule or unit;
• (f) the quantity of cannabidiol, in milligrams, that each capsule or unit could yield, taking into account the potential to convert cannabidiolic acid into cannabidiol;
• (g) the dried marihuana equivalency factor determined under section 79;
• (h) the carrier oil used;
• (i) the name of any food allergen, within the meaning of subsection B.01.010.1(1) of the Food and Drug Regulations, that is contained in the oil; and
• (j) in the case of cannabis oil that is intended for topical use only, the warning “FOR TOPICAL USE ONLY. DO NOT INGEST. / POUR USAGE TOPIQUE SEULEMENT. NE PAS INGÉRER.”.
  

Product label – marihuana seeds

85 A licensed producer who sells or provides marihuana seeds under subsection 22(5) must ensure that a label that contains the following information is affixed to the immediate container:

• (a) the name, telephone number and email address of the licensed producer;
• (b) the words “Marihuana seeds / Graines de marihuana”, “Cannabis seeds / Graines de chanvre indien” or “Cannabis seeds / Graines de cannabis”;
• (c) in respect of the seeds in the container,
  • (i) the number of seeds,
  • (ii) their brand name,
  • (iii) their lot number, preceded by one of the following designations:
    • (A) “Lot number”,
    • (B) “Lot no.”,
    • (C) “Lot”, or
    • (D) “(L)”,
  • (iv) their recommended storage conditions, and
  • (v) their packaging date; and
• (d) the information required by paragraphs 84(1)(d) to (f).

Product label – marihuana plants

86 A licensed producer who sells or provides marihuana plants under subsection 22(5) must ensure that each plant bears a label that contains the following information:

• (a) the name, telephone number and email address of the licensed producer;
• (b) the words “Marihuana plant / Plant de marihuana”, “Cannabis plant / Plant de chanvre indien” or “Cannabis plant / Plant de cannabis”;
• (c) in respect of the plant,
  • (i) its brand name,
  • (ii) its lot number, preceded by one of the following designations:
    • (A) “Lot number”,
    • (B) “Lot no.”,
    • (C) “Lot”, or
    • (D) “(L)”, and
  • (iii) its packaging date; and
• (d) the information required by paragraphs 84(1)(d) to (f).

Client label

87 (1) A licensed producer who sells or provides fresh or dried marihuana or cannabis oil under subsection 22(4) to a client or an individual who is responsible for the client must ensure that

• (a) a label that contains the following information is affixed to the immediate container:
  • (i) the client’s given name and surname,
  • (ii) the given name, surname and profession of the health care practitioner who provided the client’s medical document,
  • (iii) the name of the licensed producer,
  • (iv) the daily quantity of dried marihuana, in grams, indicated on the client’s medical document or in the client’s registration with the Minister made under Part 2,
  • (v) the expiry date of the client’s registration referred to in section 134,
  • (vi) the shipping date, and
  • (vii) the date referred to in subsection 146(2); and
• (b) a separate document containing the information referred to in paragraph (a) accompanies each shipment of the substance.

Marihuana seeds

(2) A licensed producer who sells or provides marihuana seeds under subsection 22(5) to a client or an individual who is responsible for the client must ensure that a label that contains the following information is affixed to the immediate container:

• (a) the client’s given name and surname;
• (b) the name of the licensed producer;
• (c) the expiry date of the client’s registration referred to in section 134; and
• (d) the shipping date.

Marihuana plants

(3) A licensed producer who sells or provides marihuana plants under subsection 22(5) to a client or an individual who is responsible for the client must ensure that the package referred to in subsection 80(3) or each plant bears a label that contains the following information:

• (a) the given name and surname of the client;
• (b) the name of the licensed producer;
• (c) the expiry date of the client’s registration referred to in section 134; and
• (d) the shipping date.

Combined label

88 In the case of fresh or dried marihuana, cannabis oil or marihuana plants or seeds to be sold or provided to a client or an individual who is responsible for the client, the information required under section 84 and under paragraph 87(1)(a) or subsection 87(2) or (3), as applicable, may be set out on one label.

Department of Health document

89 A licensed producer who sells or provides fresh or dried marihuana, cannabis oil or marihuana plants or seeds under subsection 22(4) or (5) must ensure that each shipment of the substance is accompanied by a copy of the current version of the document entitled Consumer Information — Cannabis (Marihuana, marijuana), published by the Department of Health.

Presentation of information — label

90 (1) All information that is required under section 84 and under paragraph 87(1)(a) or subsection 87(2) or (3), as applicable, to appear on a label must be

• (a) in English and in French;
• (b) clearly and prominently displayed on the label; and
• (c) readily discernible under the customary conditions of use.
  

Presentation of information — document

(2) All information in a document that is required under paragraph 87(1)(b) or section 89 must be in English and in French and readily discernible under the customary conditions of use.

Expiry date

91 (1) A licensed producer must not include an expiry date on a label referred to in section 84 unless

• (a) the licensed producer has submitted data to the Minister that establishes the stability period during which, after the fresh or dried marihuana or cannabis oil is packaged in accordance with section 80 and when it is stored under its recommended storage conditions referred to in subparagraph 84(1)(c)(iii),
  • (i) the substance maintains not less than 80% and not more than 120% of its delta-9-tetrahydrocannabinol content and cannabidiol content, and
  • (ii) the microbial and chemical contaminants of the substance remain within the limits referred to in section 64; and
• (b) in the Minister’s opinion the data submitted by the licensed producer meets the requirements of paragraph (a) and the Minister has notified the producer to that effect.

Definition of expiry date

(2) For the purposes of subsection (1) and subparagraph 84(1)(c)(v), expiry date means the date, expressed at minimum as a year and month, that is the end of the stability period.

Reference to Acts or regulations

92 It is prohibited to include a reference, direct or indirect, to the Act, the Food and Drugs Act or any regulations made under those Acts on a label of or in an advertisement for fresh or dried marihuana, cannabis oil or marihuana plants or seeds unless the reference is a specific requirement of either of those Acts or those regulations.

Shipping

93 (1) A licensed producer who ships fresh or dried marihuana or cannabis oil to a person referred to in subsection 22(2) or (4), or who ships a substance referred to in paragraph 22(3)(b) to a person referred to in subsection 22(2), must

• (a) ship the substance in only one shipment per order;
• (b) prepare the package in a manner that ensures the security of its contents, such that
  • (i) it will not open or permit the escape of its contents during handling and transportation,
  • (ii) it is sealed so that it cannot be opened without the seal being broken,
  • (iii) it prevents the escape of cannabis odour, and
  • (iv) it prevents its contents from being identified without it being opened;
• (c) use a shipping method that ensures the tracking and safekeeping of the package during transportation; and
• (d) ship it only to the following address:
  • (i) in the case of a client or an individual who is responsible for that client, the shipping address specified in the client’s registration document referred to in paragraph 133(2)(a), and
  • (ii) in the case of any other person referred to in subsection 22(2) or (4), the shipping address indicated in the order referred to in section 149; and
• (e) in the case of a client or an individual who is responsible for that client, ship the substance in a quantity that does not exceed the equivalent of 150 g of dried marihuana.

Marihuana seeds

(2) A licensed producer who ships marihuana seeds to a person referred to in subsection 22(2) or (5) must

• (a) comply with the requirements of paragraphs (1)(a) to (c); and
• (b) ship the package only to the following address:
  • (i) in the case of a person referred to in subsection 22(2), the shipping address indicated in the order referred to in section 149; and
  • (ii) in the case of a person referred to in subsection 22(5), the address of the site for the production of marihuana plants or the site for the storage of cannabis that is specified in the person’s registration with the Minister made under Part 2.
    

Marihuana plants

(3) A licensed producer who ships marihuana plants to a person referred to in subsection 22(2) or (5) must

• (a) prepare the package in a manner that ensures the security of its contents, such that
  • (i) it will not open or permit the escape of its contents during handling and transportation,
  • (ii) it is sealed so that it cannot be opened without the seal being broken, and
  • (iii) it prevents its contents from being identified without it being opened;
• (b) use a shipping method referred to in paragraph (1)(c); and
• (c) ship it to the address referred to in paragraph (2)(b).
  

Cannabis for in vitro testing

(4) A licensed producer who ships a substance that is referred to in paragraph 22(3)(c) to a person referred to in subsection 22(2) must

• (a) use a shipping method referred to in paragraph (1)(c); and
• (b) ship it only to the shipping address indicated in the order referred to in section 149.

SUBDIVISION G

Import and Export

Application for import permit

94 (1) To apply for a permit to import marihuana or a substance referred to in paragraph 22(3)(c), a licensed producer must submit the following information to the Minister:

• (a) their name, address and licence number;
• (b) in respect of the substance to be imported,
  • (i) its description and, in the case of marihuana, an indication of whether it is in the form of seeds, plants or dried marihuana,
  • (ii) its intended use,
  • (iii) if applicable, its brand name,
  • (iv) its quantity, and
  • (v) in the case of dried marihuana, its percentages of delta-9-tetrahydrocannabinol w/w and cannabidiol w/w;
• (c) the name and address of the exporter in the country of export;
• (d) the port of entry into Canada;
• (e) the address of the customs office, sufferance warehouse or bonded warehouse to which the substance is to be delivered; and
• (f) each mode of transportation used, the country of export and, if applicable, any country of transit or transhipment.

Statement by signatory

(2) An application for an import permit must

• (a) be signed and dated by the responsible person in charge or, if applicable, the alternate responsible person in charge at the licensed producer’s site; and
• (b) include a statement, signed and dated by that person, indicating that all information submitted in support of the application is correct and complete to the best of the signatory’s knowledge.

Issuance of import permit

95 (1) Subject to section 96, the Minister must, after examining the information and documents required under section 94 and, if applicable, section 11, issue to the licensed producer an import permit that indicates

• (a) the permit number;
• (b) the information referred to in paragraphs 94(1)(a) to (f);
• (c) the effective date of the permit;
• (d) its expiry date, which is the earlier of
  • (i) the 180th day after the effective date, and
  • (ii) December 31 of the year of the effective date; and
• (e) if applicable, any conditions that the permit holder must meet in order to
  • (i) comply with an international obligation, or
  • (ii) reduce any potential public health, safety or security risk, including the risk of the imported substance being diverted to an illicit market or use.
    

Duration of permit

(2) An import permit is valid until the earliest of

• (a) its expiry date or the date on which it is suspended or revoked under section 100 or 101, respectively,
• (b) the expiry date of the producer’s licence to which the permit pertains or the date on which that licence is suspended or revoked, and
• (c) the expiry date of the export permit that applies to the substance to be imported and that is issued by a competent authority in the country of export or the date on which that permit is suspended or revoked.
  

Validity

(3) A permit issued under this section is valid only for the importation in respect of which it is issued.

Refusal to issue import permit

96 The Minister must refuse to issue an import permit if

• (a) in respect of the application for the permit, there exists a circumstance described in paragraph 36(1)(d), (e), (f) or (h), with any modifications that the circumstances require;
• (b) the applicant does not hold a producer’s licence with respect to the substance that is to be imported;
• (c) the applicant has been notified that one of the following applications submitted by the applicant in respect of the producer’s licence to which the requested permit pertains is to be refused under section 36:
  • (i) an application under section 33 for a producer’s licence,
  • (ii) an application under section 38 for the renewal of a producer’s licence, or
  • (iii) an application under section 39 for the amendment of a producer’s licence; or
• (d) the Minister has reasonable grounds to believe that
  • (i) the shipment for which the permit is requested would contravene the laws of the country of export or any country of transit or transhipment, or
  • (ii) the importation is for the purpose of re-exporting the substance.

Provision of copy of import permit

97 On request of a customs officer, the holder of an import permit must provide a copy of the permit to the customs office, sufferance warehouse or bonded warehouse, as the case may be, at the port of entry into Canada at the time of importation.

Declaration after release from customs

98 The holder of an import permit must provide the Minister, within 15 days after the day of release, in accordance with the Customs Act, of a shipment that contains the imported substance, with a declaration that contains the following information:

• (a) the name of the licensed producer and the numbers of the producer’s licence and import permit in respect of the shipment;
• (b) the date of release of the shipment; and
• (c) in respect of the imported substance,
  • (i) its description and, in the case of marihuana, an indication of whether it is in the form of seeds, plants or dried marihuana,
  • (ii) its intended use,
  • (iii) if applicable, its brand name,
  • (iv) its quantity, and
  • (v) in the case of dried marihuana, its percentages of delta-9-tetrahydrocannabinol w/w and cannabidiol w/w.

Transportation of imported substance

99 The holder of an import permit must ensure that, after the imported substance is released, it is transported directly to the site specified in their producer’s licence.

Suspension of import permit

100 (1) The Minister must suspend an import permit without prior notice if

• (a) the Minister has reasonable grounds to believe that it is necessary to do so to protect public health, safety or security, including preventing the imported substance from being diverted to an illicit market or use; or
• (b) the importation would contravene the laws of any country of transit or transhipment.
  

Notice of suspension

(2) The suspension takes effect as soon as the Minister notifies the permit holder of the decision to suspend and provides a written report that sets out the reasons for the suspension.

Opportunity to be heard

(3) The permit holder may, within 10 days after receipt of the notice, provide the Minister with reasons why the suspension is unfounded.

Revocation of import permit

101 (1) The Minister must revoke an import permit

• (a) at the request of the holder;
• (b) if the holder informs the Minister that the permit has been lost or stolen; or
• (c) if the permit is being replaced by a new permit.
  

Revocation — other grounds

(2) Subject to subsection (3), the Minister must revoke an import permit in the following circumstances:

• (a) there exists a circumstance described in any of paragraphs 46(1)(a) to (e) in respect of the producer’s licence to which the permit pertains;
• (b) the Minister has reasonable grounds to believe that the import permit was issued on the basis of false or misleading information submitted in, or false or falsified documents submitted with, the application for the permit; or
• (c) the importation is for the purpose of re-exporting the imported substance.

Exceptions

(3) Unless it is necessary to do so to protect public health, safety or security, including preventing the imported substance from being diverted to an illicit market or use, the Minister must not revoke an import permit in the circumstances described in paragraph (2)(b) or 46(1)(a) or (b) if the permit holder has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and its regulations and the Food and Drugs Act.

Failure to comply with undertaking

(4) If the permit holder fails to comply with an undertaking mentioned in subsection (3), the Minister must revoke the permit.

Revocation following suspension

(5) The Minister must revoke a permit if the permit holder fails to comply with the suspension of the permit under section 100 or if the situation giving rise to the suspension is not rectified.

Application for export permit

102 (1) To apply for a permit to export marihuana or a substance referred to in paragraph 22(3)(c), a licensed producer must submit the following information and declaration to the Minister:

• (a) their name, address and licence number;
• (b) in respect of the substance to be exported,
  • (i) its description it and, in the case of marihuana, an indication of whether it is in the form of seeds, plants or dried marihuana,
  • (ii) its intended use,
  • (iii) if applicable, its brand name,
  • (iv) its quantity, and
  • (v) in the case of dried marihuana, its percentages of delta-9-tetrahydrocannabinol w/w and cannabidiol w/w;
• (c) the name and address of the importer in the country of final destination;
• (d) the port of exit from Canada and, if applicable, any country of transit or transhipment;
• (e) the address of the customs office, sufferance warehouse or bonded warehouse at which the shipment is to be presented for export;
• (f) each mode of transportation used; and
• (g) a declaration that, to the best of their knowledge, the shipment does not contravene the laws of the country of final destination or any country of transit or transhipment.

Accompanying document

(2) An application for an export permit must be accompanied by a copy of the import permit issued by a competent authority in the country of final destination that sets out the name and address of the site of the importer in the country of final destination.

Statement by signatory

(3) An application for an export permit must

• (a) be signed and dated by the responsible person in charge or, if applicable, the alternate responsible person in charge at the licensed producer’s site; and
• (b) include a statement, signed and dated by that person, indicating that all information submitted in support of the application is correct and complete to the best of the signatory’s knowledge.

Issuance of export permit

103 (1) Subject to section 104, the Minister must, after examining the information and documents required under section 102 and, if applicable, section 11, issue an export permit to the licensed producer that indicates

• (a) the permit number;
• (b) the information referred to in paragraphs 102(1)(a) to (f);
• (c) the effective date of the permit;
• (d) its expiry date, which is the earliest of
  • (i) the 120th day after the effective date,
  • (ii) December 31 of the year of the effective date, and
  • (iii) the expiry date of the import permit issued by a competent authority in the country of final destination; and
• (e) if applicable, any conditions that the permit holder must meet in order to
  • (i) comply with an international obligation, or
  • (ii) reduce any potential public health, safety or security risk, including the risk of the exported substance being diverted to an illicit market or use.
    

Duration of permit

(2) An export permit is valid until the earliest of

• (a) its expiry date or the date on which it is suspended or revoked under section 107 or 108, respectively,
• (b) the expiry date of the producer’s licence to which the permit pertains or the date on which the that licence is suspended or revoked, and
• (c) the expiry date of the import permit that applies to the substance to be exported and that is issued by a competent authority in the country of final destination or the date on which that permit is suspended or revoked.
  

Validity

(3) A permit issued under this section is valid only for the exportation in respect of which it is issued.

Refusal to issue export permit

104 The Minister must refuse to issue an export permit if

• (a) in respect of the application for the permit, there exists a circumstance described in paragraph 36(1)(d), (e) or (h), with any modifications that the circumstances require;
• (b) the applicant does not hold a producer’s licence in respect of the substance that is to be exported;
• (c) the applicant has been notified that one of the following applications submitted by the applicant in respect of the producer’s licence to which the requested permit pertains is to be refused under section 36:
  • (i) an application made under section 33 for a producer’s licence,
  • (ii) an application made under section 38 for the renewal of a producer’s licence, or
  • (iii) an application made under section 39 for the amendment of a producer’s licence;
• (d) the Minister has reasonable grounds to believe that the shipment for which the permit is requested would contravene the laws of the country of final destination or any country of transit or transhipment; or
• (e) the shipment would not be in conformity with the import permit issued by a competent authority of the country of final destination.

Provision of copy of export permit

105 On request of a customs officer, the holder of an export permit must provide a copy of the permit to the customs office, sufferance warehouse or bonded warehouse, as the case may be, at the port of exit from Canada at the time of exportation.

Declaration after export

106 The holder of an export permit must provide the Minister, within 15 days after the day on which a shipment of the substance is exported, with a declaration that contains the following information:

• (a) the name of the licensed producer and the numbers of the producer’s licence and export permit in respect of the shipment;
• (b) the date of export; and
• (c) in respect of the exported substance,
  • (i) its description and, in the case of marihuana, an indication as to whether it is in the form of seeds, plants or dried marihuana,
  • (ii) its intended use,
  • (iii) if applicable, its brand name,
  • (iv) its quantity, and
  • (v) in the case of dried marihuana, its percentages of delta-9-tetrahydrocannabinol w/w and cannabidiol w/w.

Suspension of export permit

107 (1) The Minister must suspend an export permit without prior notice if

• (a) the Minister has reasonable grounds to believe that it is necessary to do so to protect public health, safety or security, including preventing the exported substance from being diverted to an illicit market or use;
• (b) the exportation is not in conformity with an import permit issued by a competent authority of the country of final destination; or
• (c) the exportation would contravene the laws of the country of final destination or any country of transit or transhipment.
  

Notice of suspension

(2) The suspension takes effect as soon as the Minister notifies the permit holder of the decision to suspend and provides a written report that sets out the reasons for the suspension.

• 
  Opportunity to be heard
• (3) The permit holder may, within 10 days after receipt of the notice, provide the Minister with reasons why the suspension is unfounded.

Revocation of export permit

108 (1) The Minister must revoke an export permit

• (a) at the request of the holder;
• (b) if the holder informs the Minister that the permit has been lost or stolen; or
• (c) if the permit is being replaced by a new permit.
  

Revocation — other grounds

(2) Subject to subsection (3), the Minister must revoke an export permit in the following circumstances:

• (a) there exists a circumstance described in any of paragraphs 46(1)(a) to (e) in respect of the producer’s licence to which the permit pertains; or
• (b) the Minister has reasonable grounds to believe that the export permit was issued on the basis of false or misleading information submitted in, or false or falsified documents submitted with, the application.
  

Exceptions

(3) Unless it is necessary to do so to protect public health, safety or security, including preventing the exported substance from being diverted to an illicit market or use, the Minister must not revoke an export permit in the circumstances described in paragraph (2)(b) or 46(1)(a) or (b) if the permit holder has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and its regulations and the Food and Drugs Act.

Failure to comply with undertaking

(4) If the permit holder fails to comply with an undertaking mentioned in subsection (3), the Minister must revoke the permit.

Revocation following suspension

(5) The Minister must revoke a permit if the permit holder fails to comply with the suspension of the permit under section 107 or if the situation giving rise to the suspension is not rectified.

SUBDIVISION H

Security Clearances

Eligibility

109 Only the following persons may submit to the Minister an application for a security clearance:

• (a) a person named in an application for a producer’s licence as
  • (i) the proposed senior person in charge,
  • (ii) the proposed responsible person in charge, or
  • (iii) if applicable, the proposed alternate responsible person in charge;
• (b) if a producer’s licence is sought by an individual, that individual;
• (c) if a producer’s licence is sought by a corporation, each officer and director of the corporation;
• (d) a person referred to in any of subparagraphs 40(1)(a)(i) to (iii); and
• (e) the holder of a security clearance who is seeking to obtain a new security clearance before the end of the validity period of their current clearance.
  

Application for security clearance

110 (1) An application for a security clearance must include the following information and documentation, to be used only for the purposes of sections 111 and 112:

• (a) the applicant’s usual given name used, other given names, surname, all other names used and details of any name changes;
• (b) the applicant’s date of birth, gender, height, weight, and eye and hair colour;
• (c) if the applicant was born in Canada, the number and province of issue of their birth certificate;
• (d) if the applicant was born outside Canada, their place of birth, the port and date of entry into Canada, and, in the case of a naturalized Canadian or permanent resident, the number of the applicable certificate issued under the Citizenship Act or the Immigration and Refugee Protection Act;
• (e) either of the following documents:
  • (i) a copy of a valid piece of photo identification of the applicant issued by the Government of Canada or the government of a province, or
  • (ii) a copy of the applicant’s passport that includes the passport number, country of issue and expiry date and the applicant’s photograph;
• (f) the addresses of all locations at which the applicant resided during the five years preceding the application;
• (g) an identification of the applicant’s activities during the five years preceding the application, including the names and addresses of the applicant’s employers and any post-secondary educational institutions attended;
• (h) the dates, destination and purpose of any travel of more than 90 days outside Canada, excluding travel for government business, during the five years preceding the application;
• (i) the information referred to in subsection (2) respecting
  • (i) the applicant’s spouse or common-law partner, and
  • (ii) any former spouses or common-law partners with whom the relationship ended within the five years preceding the application;
• (j) the applicant’s fingerprints, taken by a Canadian police force or by a private company that is accredited by the Royal Canadian Mounted Police to submit fingerprints to it for the purpose of a criminal record check; and
• (k) a declaration signed and dated by the licensed producer or the applicant for a producer’s licence stating that the applicant for the security clearance requires or will require a security clearance and specifying the reasons for that requirement.
  

Spouse or common-law partner

(2) The information required in respect of any of the persons referred to in paragraph (1)(i) is

• (a) in the case of the applicant’s spouse or common-law partner, the following information:
  • (i) their gender, full given name, surname and, if applicable, maiden name,
  • (ii) their date and place of birth and, if applicable, date of death,
  • (iii) if born in Canada, the number and province of issue of their birth certificate,
  • (iv) if born outside Canada, their place of birth, their nationality and the port and date of entry into Canada, and
  • (v) their present address, if known; and
• (b) in the case of former spouses and common-law partners with whom the relationship ended within the five years preceding the application, the information referred to in subparagraphs (a)(i), (ii) and (v).

Signed by applicant

(3) The application for a security clearance must be signed and dated by the applicant.

Definition of common-law partner

(4) In this section, common-law partner means any person who is cohabiting with the applicant in a relationship of a conjugal nature and has done so for a period of at least one year.

Checks

111 On receipt of a fully completed application for a security clearance, the Minister must conduct the following checks for the purpose of assessing whether an applicant poses a risk to the integrity of the control of the production and distribution of cannabis under the Act and its regulations, including the risk of cannabis being diverted to an illicit market or use:

• (a) a criminal record check in respect of the applicant; and
• (b) a check of the relevant files of law enforcement agencies, including intelligence gathered for law enforcement purposes.

Minister’s decision

112 The Minister may grant a security clearance if, in the Minister’s opinion, the information provided by the applicant and that resulting from the checks is reliable and is sufficient for the Minister to determine, by taking into account the following factors, that the applicant does not pose an unacceptable risk to the integrity of the control of the production and distribution of cannabis under the Act and its regulations, including the risk of cannabis being diverted to an illicit market or use:

• (a) whether, within the preceding 10 years, the applicant
  • (i) has been convicted, as an adult, of a designated drug offence as defined in section 2 of the Narcotic Control Regulations or a designated criminal offence as defined in that section,
  • (ii) has been convicted, as an adult, of an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i),
  • (iii) has been convicted of an offence referred to in subparagraph (i) as a young person in ordinary court, as those terms were defined in subsection 2(1) of the Young Offenders Act, chapter Y-1 of the Revised Statutes of Canada, 1985, immediately before that Act was repealed,
  • (iv) has received an adult sentence as a young person, as those terms are defined in subsection 2(1) of the Youth Criminal Justice Act, in respect of an offence referred to in subparagraph (i), or
  • (v) has received a sentence — for an offence they committed outside Canada when they were at least 14 years old but less than 18 years old that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) — that was longer than the maximum youth sentence that could have been imposed under the Youth Criminal Justice Act for such an offence;
• (b) whether it is known or there are reasonable grounds to suspect that the applicant
  • (i) is or has been involved in, or contributes or has contributed to, illicit activities directed toward or in support of the trafficking or diversion of controlled substances or precursors,
  • (ii) is or has been a member of a criminal organization as defined in subsection 467.1(1) of the Criminal Code, or participates or has participated in, or contributes or has contributed to, the activities of such an organization as referred to in subsection 467.11(1) of the Criminal Code,
  • (iii) is or has been a member of an organization that is known to be involved in or to contribute to — or in respect of which there are reasonable grounds to suspect involvement in or contribution to — activities directed toward or in support of the threat of or the use of acts of violence against persons or property, or is or has been involved in, or is contributing to or has contributed to, the activities of such an organization, or
  • (iv) is or has been associated with an individual who is known to be involved in or to contribute to — or in respect of whom there are reasonable grounds to suspect involvement in or contribution to — activities referred to in subparagraph (i), or is a member of an organization referred to in subparagraph (ii) or (iii);
• (c) whether there are reasonable grounds to suspect that the applicant is in a position in which there is a risk that they be induced to commit an act or to aid or abet any person to commit an act that might constitute a risk to the integrity of the control of the production and distribution of cannabis under the Act and its regulations, including the risk of cannabis being diverted to an illicit market or use;
• (d) whether the applicant has had a security clearance cancelled; and
• (e) whether the applicant has submitted false or misleading information in, or false or falsified documents with, their application for a security clearance.
  

Outstanding criminal charge

113 If there is an outstanding criminal charge against the applicant that could, if the applicant were convicted, be taken into account by the Minister under paragraph 112(a), the Minister may decline to process the application until the charge has been disposed of by the courts, in which case the Minister must notify the applicant in writing.

Refusal to grant security clearance

114 (1) If the Minister intends to refuse to grant a security clearance, the Minister must notify the applicant in writing to that effect.

Content of notice

(2) The notice must set out the basis for the Minister’s intention and fix a period of time within which the applicant may make written representations to the Minister, which period of time must start on the day on which the notice is served or sent and must be not less than 20 days.

Opportunity to make written representations

(3) The Minister must not refuse to grant a security clearance until the written representations have been received and considered or before the period of time fixed in the notice has expired, whichever comes first. The Minister must notify the applicant in writing of any refusal.

Validity period

115 (1) The Minister must establish a period of validity for a security clearance in accordance with the level of risk posed by the applicant as determined under section 112, but the period must not exceed five years.

Extension of period

(2) If the validity period is less than five years, the Minister may extend the period to a total of five years if the Minister determines under section 112 that the holder does not pose an unacceptable risk to the integrity of the control of the production and distribution of cannabis under the Act and its regulations, including the risk of cannabis being diverted to an illicit market or use.

Security clearance no longer required

116 A licensed producer must notify the Minister in writing not later than five days after the holder of a security clearance is no longer required under this Part to hold a security clearance. The Minister must then cancel the clearance.

Suspension of security clearance

117 (1) The Minister may suspend a security clearance on receipt of information that could change the Minister’s determination made under section 112.

Written notice to holder

(2) Immediately after suspending a security clearance, the Minister must notify the holder in writing of the suspension.

Content of notice

(3) The notice must set out the basis for the suspension and fix a period of time within which the holder may make written representations to the Minister, which period of time must start on the day on which the notice is served or sent and must be not less than 20 days.

Reinstatement of clearance

(4) The Minister may reinstate the security clearance if the Minister determines under section 112 that the holder does not pose an unacceptable risk to the integrity of the control of the production and distribution of cannabis under the Act and its regulations, including the risk of cannabis being diverted to an illicit market or use.

Cancellation of clearance

(5) The Minister may cancel the security clearance if the Minister determines under section 112 that the holder may pose an unacceptable risk to the integrity of the control of the production and distribution of cannabis under the Act and its regulations, including the risk of cannabis being diverted to an illicit market or use. The Minister must notify the holder in writing of any cancellation.

Opportunity to be heard

(6) The Minister must not cancel the security clearance until the written representations referred to in subsection (3) have been received and considered or before the time period fixed in the notice referred to in that subsection has expired, whichever comes first.

New applications

118 If the Minister refuses to grant or cancels a security clearance, an applicant may submit a new application only if

• (a) a period of five years has elapsed since the day on which the refusal or cancellation occurs; or
• (b) a change has occurred in the circumstances that led to the refusal or cancellation.

Sending of notices by Minister

119 The Minister must send any notice to be given under this Subdivision to the person at their last known address by using a method of sending that involves

• (a) a means of tracking it during transit;
• (b) the safekeeping of it during transit; and
• (c) the keeping of an accurate record of the signatures of any persons having charge of it until it is delivered.
  

False or misleading information

120 It is prohibited to knowingly submit to the Minister an application containing false or misleading information in order to obtain a security clearance.

SUBDIVISION I

Communication of Information

Information concerning clients

121 (1) Subject to subsection (2), if a licensed producer is provided with the given name, surname, date of birth and gender of an individual by a member of a Canadian police force who requests information in the course of an investigation under the Act or these Regulations, the licensed producer must provide as soon as feasible, within 72 hours after receiving the request, the following information to that Canadian police force:

• (a) an indication of whether or not the individual is
  • (i) one of their clients, or
  • (ii) an individual who is responsible for one of their clients;
• (b) in the case of one of their clients, whether the client is registered with the Minister under Part 2 and, if so, whether the client’s registration with the producer is for the purpose of obtaining
  • (i) an interim supply of fresh or dried marihuana or cannabis oil,
  • (ii) marihuana plants or seeds, or
  • (iii) the substances referred to in subparagraphs (i) and (ii); and
• (c) the daily quantity of dried marihuana that is specified in the medical document supporting the client’s registration or that is specified in that individual’s registration with the Minister made under Part 2.
  

Verification

(2) Before providing the requested information, the licensed producer must verify in a reasonable manner that the person requesting the information is a member of a Canadian police force.

Use of information

(3) Information provided under this section must be used only for the purposes of the investigation referred to in subsection (1) and for the proper administration or enforcement of the Act or these Regulations.

Definition of health care practitioner

122 In sections 123 and 124, health care practitioner means

• (a) a person who is, or was, registered and entitled under the laws of a province to practise medicine in that province; or
• (b) a person who is, or was, a nurse practitioner as defined in section 1 of the New Classes of Practitioners Regulations and who is, or was, permitted to prescribe dried marihuana in the province in which they practise or practised.

Information concerning health care practitioners

123 (1) A licensed producer must provide in writing, as soon as feasible, any factual information about a health care practitioner that has been obtained under the Act or these Regulations to the licensing authority that is responsible for the registration or authorization of persons to practise the profession

• (a) in a province in which the practitioner is, or was, authorized to practise, if the authority submits to the licensed producer a written request that sets out the practitioner’s name and address, a description of the information being sought and a declaration that the information is required for the purpose of assisting an official investigation by the authority; or
• (b) in a province in which the practitioner is not authorized to practise, if the authority submits to the licensed producer
  • (i) a written request that sets out the practitioner’s name and address and a description of the information being sought, and
  • (ii) either
    • (A) documentation that shows that the practitioner has applied to that authority to practise in that province, or
    • (B) documentation that shows that the authority has reasonable grounds to believe that the practitioner is practising in that province without being authorized to do so.

Factual information

(2) The factual information that may be requested includes information — notably patient information — contained in, or in respect of,

• (a) any medical document that has been signed by the practitioner and that has formed the basis for registering a client;
• (b) any authorization to possess that has formed the basis for registering a client and that was issued under the former Marihuana Medical Access Regulations on the basis of a medical declaration that was made by the practitioner; and
• (c) any medical declaration that was made by the practitioner under those former Regulations and that has formed the basis for registering a client.
  

Exception

(3) The factual information that may be requested does not include information relating to clients who have registered with the licensed producer on the basis of a registration with the Minister made under Part 2.

Secure transmission

(4) A licensed producer must ensure that the information that they provide under this section is securely transmitted.

Quarterly reports to licensing authorities

124 (1) A licensing authority that is responsible for the registration or authorization of persons to practise medicine or nursing in a province may submit a written request to a licensed producer to obtain information, on a quarterly basis, in respect of each client who is registered by the producer on the basis of a medical document that was signed by a health care practitioner who was entitled, at the time of the verification performed in accordance with section 132, to practise the relevant profession in the province and was consulted in that province.

Information

(2) A licensed producer who receives a request must, after the end of each quarter and in accordance with subsection (3), provide the licensing authority with the following information in respect of each client referred to in subsection (1) who was validly registered at any time during the relevant quarter, together with details of any changes to the information that have occurred during the quarter:

• (a) the client’s given name, surname and date of birth;
• (b) the postal code for, and the name of the province specified in, the address provided under subparagraph 130(1)(b)(i) or (ii);
• (c) the given name, surname and business address of the health care practitioner who signed the medical document and the number assigned by the province to the practitioner’s authorization to practise;
• (d) the daily quantity of dried marihuana that is specified in the medical document;
• (e) the period of use that is specified in the medical document;
• (f) the date on which the medical document was signed by the practitioner; and
• (g) if fresh or dried marihuana or cannabis oil was shipped to the client during the quarter, the quantity of the substance, in grams, contained in each shipment and the dates of the shipments.

Quarterly deadlines

(3) The information must be provided to the licensing authority by

• (a) April 30 of a given year for the quarter beginning on January 1 and ending on March 31 of that year;
• (b) July 31 of a given year for the quarter beginning on April 1 and ending on June 30 of that year;
• (c) October 31 of a given year for the quarter beginning on July 1 and ending on September 30 of that year; and
• (d) January 31 of a given year for the quarter beginning on October 1 and ending on December 31 of the previous year.

Initial report

(4) For greater certainty, for the purposes of subsection (2), the first quarter in respect of which information must be provided is the quarter in which the request is received.

No information to provide

(5) If the licensed producer has no information to provide for a quarter, they must send a notice to that effect to the licensing authority by the relevant deadline referred to in subsection (3).

Deadline — ceasing activities

(6) If the licensed producer ceases to conduct activities, any information that they are required to provide to the licensing authority must, despite subsection (3), be provided no later than 30 days after the activities cease.

Revocation notice

(7) The licensing authority may, at any time, send the licensed producer a notice revoking the request referred to in subsection (1), in which case the final quarter in respect of which information must be provided to the authority is the one that precedes the quarter in which the notice is received.

Transmission of information

(8) A licensed producer, or former licensed producer, who provides information to a licensing authority under this section must

• (a) ensure that the information is securely transmitted in accordance with the specifications set out in the Directive on the Electronic Transmission of Information Under the Controlled Drugs and Substances Act published by the Department of Health, as amended from time to time; and
• (b) provide the information only in an electronic format that is set out in that directive.

Information concerning licensed producers

125 The Minister is authorized to provide any information set out in a notice referred to in section 48, 49 or 50 to a Canadian police force or a member of a Canadian police force who requests the information in the course of an investigation under the Act or these Regulations, subject to that information being used only for the purposes of that investigation and the proper administration or enforcement of the Act or these Regulations.

Information concerning import or export permit

126 The Minister is authorized, for the purpose of verifying whether an importation or exportation of marihuana or a substance referred to in paragraph 22(3)(c) complies with this Part, to provide to a customs officer in Canada any information referred to in sections 94, 95, 98, 102, 103 and 106 and to inform them whether a permit has been suspended or revoked.

Providing information to foreign organizations

127 The Minister is authorized, for the proper administration or enforcement of the Act or these Regulations and for the purpose of enabling Canada to fulfill its international obligations under article 12 of the United Nations Single Convention on Narcotic Drugs, 1961, to provide the following information and documents to the International Narcotics Control Board or a competent authority:

• (a) any information or document that a licensed producer is required to provide to the Minister under this Division;
• (b) any information pertaining to an activity authorized by a licence or permit issued to a licensed producer under this Part, including the licensed producer’s name, the nature of the authorized activity and any conditions specified in the licence or permit;
• (c) in respect of cannabis that a licensed producer receives from another licensed producer or a licensed dealer, the following information:
  • (i) in the case of fresh or dried marihuana or cannabis oil, its quantity and the date on which it was received, or
  • (ii) in the case of cannabis other than substances referred to in subparagraph (i), the name of the substance in question, its quantity and the date on which it was received;
• (d) in respect of an order that a licensed producer fills under section 143, the quantity of fresh or dried marihuana, cannabis oil or marihuana plants or seeds and the date on which it was shipped;
• (e) in respect of an order that a licensed producer fills under subsection 149(1) or (2), the following information:
  • (i) in the case of dried marihuana, its quantity and the date on which it was shipped, or
  • (ii) in the case of cannabis other than dried marihuana, the name of the substance in question, its quantity and the date on which it was shipped;
• (f) any record that a licensed producer is required to keep under subsection 161(2) or section 163, 164 or 166; and
• (g) a copy of any permit issued under section 95 or 103.
  

Security clearance — Minister

128 The Minister is authorized to communicate to a law enforcement agency information concerning an application for a security clearance for the purpose of conducting the checks referred to in section 111, subject to that information being used by that agency only for that purpose.

DIVISION 2

Client Registration and Ordering

Registration

Eligibility

129 An individual is eligible to be a client of a licensed producer only if they ordinarily reside in Canada.

Registration application

130 (1) Before registering an individual as a client, a licensed producer must obtain from the individual or an individual who is responsible for the individual an application that contains the following information, as well as the original of the applicant’s medical document or a copy of their registration certificate issued by the Minister under Part 2:

• (a) the applicant’s given name, surname, date of birth and gender;
• (b) either
  • (i) the address of the place in Canada where the applicant ordinarily resides, as well as, if applicable, the applicant’s telephone number, facsimile number and email address, or
  • (ii) if the applicant ordinarily resides in Canada but has no dwelling place, the address, as well as, if applicable, the telephone number, facsimile number and email address of a shelter, hostel or similar institution, located in Canada, that provides food, lodging or other social services to the applicant;
• (c) the mailing address of the place referred to in paragraph (b), if different from the address provided under that paragraph;
• (d) if applicable, the given name, surname, date of birth and gender of one or more individuals who are responsible for the applicant;
• (e) if the place referred to in subparagraph (b)(i) is an establishment that is not a private residence, the type and name of the establishment;
• (f) an indication as to which of the following is to be their shipping address for fresh or dried marihuana or cannabis oil:
  • (i) the address referred to in subparagraph (b)(i),
  • (ii) the mailing address of the place referred to in subparagraph (b)(i), or
  • (iii) the address of the health care practitioner who provided the medical document, if the practitioner has given their consent under section 131 to receive the shipment on behalf of the applicant; and
• (g) in the case of a registration application that is made on the basis of a registration with the Minister made under Part 2,
  • (i) an indication as to whether the application is being made for the purpose of obtaining
    • (A) an interim supply of fresh or dried marihuana or cannabis oil,
    • (B) marihuana plants or seeds, or
    • (C) the substances referred to in clauses (A) and (B), and
  • (ii) if applicable, the applicant’s shipping address for marihuana plants or seeds, which must be one of the following addresses that is specified in their registration with the Minister:
    • (A) the address of the site for the production of marihuana plants, or
    • (B) the address of the site for the storage of cannabis.

Statement — application supported by medical document

(2) An application that is supported by a medical document must be signed and dated by the applicant or an individual who is responsible for the applicant and include a statement that

• (a) the applicant ordinarily resides in Canada;
• (b) the information in the application and the medical document is correct and complete;
• (c) the medical document is not being used to seek or obtain fresh or dried marihuana or cannabis oil from another source;
• (d) the original of the medical document is provided in support of the application; and
• (e) the applicant will use fresh or dried marihuana or cannabis oil only for their own medical purposes.
  

Statement — application supported by registration certificate

(3) An application that is supported by a copy of a registration certificate issued by the Minister under Part 2 must be signed and dated by the applicant or an individual who is responsible for the applicant and include a statement that

• (a) the applicant ordinarily resides in Canada;
• (b) the information in the application and the registration certificate is correct and complete; and
• (c) if the application is being made for the purpose of obtaining fresh or dried marihuana or cannabis oil,
  • (i) the registration certificate is not being used to seek or obtain those substances from another source, and
  • (ii) the applicant will use those substances only for their own medical purposes.
    

Statement by responsible individual

(4) If the application is signed and dated by an individual who is responsible for the applicant, it must include a statement by that individual that they are responsible for the applicant.

Homeless applicant

(5) If an application includes the information referred to in subparagraph (1)(b)(ii), the applicant must include with the application an attestation of residence signed and dated by a manager of the specified shelter, hostel or similar institution confirming that the institution provides food, lodging or other social services to the applicant.

Health care practitioner’s consent to receive substance

131 (1) If the shipping address specified in a registration application is the one referred to in subparagraph 130(1)(f)(iii), the applicant must include with the application a statement signed and dated by the health care practitioner who provided the medical document to the applicant indicating that the practitioner consents to receive fresh or dried marihuana or cannabis oil on behalf of the applicant.

Withdrawal of consent

(2) If the applicant becomes a client of a licensed producer in accordance with section 133 and the health care practitioner ceases to consent to receive that substance on behalf of the client, the practitioner must send a written notice to that effect to the client and the licensed producer.

No further shipments

(3) A licensed producer who receives such a notice must not send any further shipments of that substance to that health care practitioner for that client.

Amendment to registration

(4) A client who receives such a notice and wishes to specify a new shipping address must submit to the licensed producer a registration amendment application in accordance with section 137.

Verification of medical document

132 (1) A licensed producer who receives an application under section 130 that is supported by a medical document and who intends to register the applicant must ensure that

• (a) the medical document that supports the application meets all of the requirements of section 8;
• (b) the person who provided the applicant with the medical document
  • (i) is a health care practitioner,
  • (ii) is entitled to practise their profession in the province in which the applicant consulted with that person, and
  • (iii) is not named in a notice issued under section 59 of the Narcotic Control Regulations that has not been retracted under section 60 of those Regulations; and
• (c) the applicant has consulted with the person referred to in paragraph (b) and the information set out in the medical document is correct and complete, as confirmed by the office of that person.

Exception

(2) The licensed producer is not required to do the verifications referred to in paragraph (1)(c) if the signature of the health care practitioner who provided the medical document is known to the producer.

Registration of client

133 (1) Subject to section 135, a licensed producer may register an applicant as a client.

Registration document and unique identifier

(2) If the licensed producer registers the applicant as a client, the producer must

• (a) send the client a registration document that contains the following information:
  • (i) the name of the producer, and
  • (ii) in respect of the client,
    • (A) the client’s given name, surname, date of birth and gender,
    • (B) the address referred to in subparagraph 130(1)(b)(i) or (ii),
    • (C) the client’s shipping address in Canada
      • (I) for fresh or dried marihuana or cannabis oil, as specified in paragraph 130(1)(f); and
      • (II) for marihuana plants and seeds, as specified in subparagraph 130(1)(g)(ii), and
    • (D) the expiry date of the registration; and
• (b) provide the client with information that will permit the client to use a unique identifier for the purpose of ordering fresh or dried marihuana, cannabis oil or marihuana plants or seeds.
  

Expiry of registration

134 A client’s registration with the licensed producer expires at the end of the period of validity of

• (a) the medical document that supports it, as determined in accordance with subsection 8(3); or
• (b) the registration with the Minister made under Part 2 that supports it.

Refusal to register

135 (1) A licensed producer must refuse to register an applicant as a client if

• (a) the application does not meet the requirements of section 130;
• (b) the licensed producer has reasonable grounds to believe that false or misleading information was submitted in, or false or falsified documents were submitted with, the application;
• (c) the requirements of section 132 are not met;
• (d) the medical document that is submitted with the application is no longer valid;
• (e) the registration with the Minister made under Part 2 that supports the application has expired or been cancelled;
• (f) the given name, surname or date of birth of the applicant is different from the given name, surname or date of birth that appears on the medical document or the registration certificate issued by the Minister under Part 2;
• (g) the health care practitioner who provided the medical document to the applicant notifies the licensed producer in writing that the use of dried marihuana by the applicant is no longer supported for clinical reasons;
• (h) in the case of an application that is being made for the purpose of obtaining fresh or dried marihuana or cannabis oil and that is supported by a registration with the Minister made under Part 2, the registration certificate has been used to seek or obtain those substances from another source; or
• (i) the address specified in the application under subparagraph 130(1)(b)(i) or (ii) is not in Canada.

Verification

(2) If a licensed producer has reasonable grounds to believe that a medical document submitted with an application is false or falsified, they must, before refusing to register the applicant, verify the validity of the document by contacting the office of the health care practitioner who purportedly signed the document.

Notice to Minister

(3) If a licensed producer refuses to register an applicant whose application is supported by a registration with the Minister made under Part 2, they must notify the Minister of the refusal and provide the Minister with the following information:

• (a) the given name and surname of the person named in the Part 2 registration;
• (b) the person’s date of birth;
• (c) the registration number of the Part 2 registration;
• (d) the date of the refusal; and
• (e) the reason for the refusal.
  

Notice — refusal to register

136 (1) A licensed producer who proposes to refuse to register an applicant for a ground set out in subsection 135(1) or for a business reason must without delay send the applicant a notice that indicates the reason for the proposed refusal.

Opportunity to be heard

(2) The applicant may, within 10 days after receipt of the notice, provide the licensed producer with reasons why the refusal is unfounded.

Return of medical document

(3) A licensed producer who refuses to register an applicant must return to the applicant without delay any medical document that was submitted with the application.

Application to amend registration

137 (1) An application to amend a registration must be made to the licensed producer by the client or an individual who is responsible for the client when a change occurs in respect of any of the information provided under subsection 130(1).

Content of application

(2) The application must include

• (a) the requested amendment;
• (b) in the case of a change to any of the information provided under paragraph 130(1)(a), proof of the change; and
• (c) in the case of a change to the information provided under subparagraph 130(1)(f)(iii), the statement referred to in subsection 131(1).
  

Statement

(3) The application must be signed and dated by the client or an individual who is responsible for the client and include a statement that

• (a) the client ordinarily resides in Canada; and
• (b) the information in the application is correct and complete.

Statement by responsible individual

(4) If the application is signed and dated by an individual who is responsible for the client, it must include a statement by that individual that they are responsible for the client.

Amendment

138 (1) A licensed producer must amend a client’s registration if the client’s amendment application meets the requirements of subsections 137(2) and (3).

Amended registration document

(2) If the licensed producer amends the client’s registration, the producer must send the client an amended registration document that contains the information referred to in subparagraphs 133(2)(a)(i) and (ii).

Cancellation of registration

139 (1) A licensed producer must cancel the registration of a client if

• (a) the client or an individual who is responsible for the client requests the licensed producer to cancel the registration;
• (b) the client dies, ceases to ordinarily reside in Canada or ceases to have a shipping address in Canada;
• (c) the licensed producer has reasonable grounds to believe that
  • (i) the registration was made on the basis of false or misleading information submitted in, or false or falsified documents submitted with, the registration application, or
  • (ii) false or misleading information was submitted in, or false or falsified documents were submitted with, the application to amend the registration;
• (d) the health care practitioner who provided the medical document to the client notifies the licensed producer in writing that the use of dried marihuana by the client is no longer supported for clinical reasons;
• (e) the health care practitioner who provided the medical document to the client is named in a notice issued under section 59 of the Narcotic Control Regulations that has not been retracted under section 60 of those Regulations; or
• (f) the licensed producer is notified that the registration with the Minister made under Part 2 that supports the registration with the producer has been cancelled.
  

Time of cancellation

(2) The licensed producer must cancel the registration of the client without delay if the producer

• (a) receives a request referred to in paragraph (1)(a) or a written notice under paragraph (1)(d);
• (b) becomes aware of a ground referred to in paragraph (1)(b), (e) or (f) and has verified in a reasonable manner the existence of the ground; or
• (c) has reasonable grounds to believe that a ground referred to in subparagraph (1)(c)(i) or (ii) exists.

Cancellation by producer for business reason

(3) A licensed producer may also cancel the registration of a client for a business reason.

Notice

(4) Except in the case of the death of a client, a licensed producer who proposes to cancel a client’s registration under subsection (1) or (3) must without delay send a notice that indicates the reason for the cancellation to the client.

Opportunity to be heard

(5) The client or an individual who is responsible for the client may, within 10 days after receipt of the notice referred to in subsection (4), provide the licensed producer with reasons why the cancellation is unfounded.

Cancellation of all registrations

(6) A licensed producer whose licence is revoked must, without delay,

• (a) cancel the registrations of all of their clients; and
• (b) send a notice to each client that indicates the reason for the cancellation.

Medical document

(7) A licensed producer who cancels a client’s registration must not return the medical document.

Notice to Minister

(8) If a licensed producer cancels a registration that is supported by a registration with the Minister made under Part 2, they must notify the Minister of the cancellation and provide the Minister with the following information:

• (a) the given name and surname of the person named in the Part 2 registration;
• (b) the person’s date of birth;
• (c) the registration number of the Part 2 registration;
• (d) the date of the cancellation; and
• (e) the reason for the cancellation.
  

Prohibition — transfer of document

140 A licensed producer must not transfer to any person

• (a) a medical document on the basis of which a client has been registered; or
• (b) a copy of a registration certificate issued by the Minister under Part 2 on the basis of which a client has been registered.
  

New Medical Document or Registration Certificate

New application – new medical document

141 (1) A licensed producer must not sell or provide fresh or dried marihuana or cannabis oil to a client or an individual who is responsible for the client on the basis of a new medical document unless the client or the individual submits to the producer a new registration application that meets the requirements of section 130.

New application – new registration certificate

(2) A licensed producer must not sell or provide fresh or dried marihuana, cannabis oil or marihuana plants or seeds to a client or an individual who is responsible for the client on the basis of a new registration certificate issued by the Minister under Part 2 unless the client or the individual submits to the producer a new registration application that meets the requirements of section 130.

Applicable provisions

142 Sections 131 to 136 apply to an application under section 141.

Processing an Order

Order required

143 (1) A licensed producer must not sell or provide fresh or dried marihuana, cannabis oil or marihuana plants or seeds to a client or an individual who is responsible for the client unless the producer has first received, from the client or the individual, a written order in accordance with subsection (2) or a verbal order recorded in accordance with subsection (3).

Written orders

(2) A written order must

• (a) be dated as of the day on which it is placed;
• (b) set out
  • (i) the given name, surname and date of birth of the client for whom the order is placed,
  • (ii) the given name and surname of the person placing the order,
  • (iii) the shipping address specified in the client’s registration document for the substance being ordered, and
  • (iv) the client’s unique identifier; and
• (c) specify the name of the substance being ordered and its quantity and brand name.

Verbal orders

(3) A licensed producer who receives a verbal order must, before filling the order, make a record of the information referred to in section 155.

Shipping

144 In filling an order referred to in section 143, a licensed producer must not transfer physical possession of the fresh or dried marihuana, cannabis oil or marihuana plants or seeds to the client or to an individual who is responsible for that client other than by shipping it to that person.

Refusal

145 (1) A licensed producer must refuse to fill an order referred to in section 143 if

• (a) the order does not meet the requirements of section 143;
• (b) any of the information that is referred to in subparagraph 143(2)(b)(i) or (iii) does not correspond to the information set out in the client’s registration document in accordance with clause 133(2)(a)(ii)(A) or (C);
• (c) the client’s unique identifier referred to in subparagraph 143(2)(b)(iv) is not correct;
• (d) the client’s registration has expired or been cancelled;
• (e) the order specifies a quantity of fresh or dried marihuana or cannabis oil that exceeds the equivalent of 150 g of dried marihuana;
• (f) the order specifies a total quantity of marihuana plants and seeds that, taking into account the equivalency factor specified in subsection (2), exceeds the equivalent of the maximum number of plants, determined in accordance with section 190, that are authorized to be under production under the client’s registration with the Minister made under Part 2;
• (g) the order has been previously filled in whole or in part; or
• (h) more than 30 days have elapsed since the date referred to in paragraph 143(2)(a) or 155(a).

Equivalency factor

(2) For the purposes of paragraph (1)(f), three marihuana seeds are equivalent to one marihuana plant.

Notice of refusal

(3) The licensed producer must send the client a written notice of the reason for the refusal.

Thirty-day limit

146 (1) A licensed producer must not sell or provide to a client or an individual who is responsible for the client in a 30-day period a total quantity of fresh marihuana, dried marihuana and cannabis oil that exceeds the equivalent of 30 times the daily quantity of dried marihuana referred to in paragraph 8(1)(d).

Date of sale

(2) The quantity is considered to have been sold or provided, for the purposes of subsection (1), on the day on which the licensed producer reasonably anticipates that it will be received by the client.

Definition of 30-day period

(3) In this section, 30-day period means

• (a) the 30-day period beginning on the day on which the licensed producer is considered, under subsection (2), to first sell or provide a substance to the client or the individual who is responsible for the client under the client’s current registration with the producer; and
• (b) every 30-day period after the period referred to in paragraph (a).
  

First 30-day period

(4) For the purpose of applying subsection (3), the first 30-day period begins on the day on which the licensed producer is considered, under subsection (2), to first sell or provide a substance to the client or the individual who is responsible for the client after the day on which that subsection comes into force, even if the producer previously sold or provided a substance to them under the client’s current registration with the producer.

Return

(5) If the client or an individual who is responsible for the client returns to the licensed producer a substance that the producer sold or provided to them, the producer may replace the returned substance with an equal quantity, to a maximum of a quantity that does not exceed the equivalent of 150 g of dried marihuana.

Exclusion

(6) The quantity of the substance that the licensed producer provides to the client or an individual who is responsible for the client to replace the returned substance is to be excluded for the purpose of calculating the total quantity referred to in subsection (1).

Return of marihuana plants or seeds

147 If a client or their designated person returns to a licensed producer marihuana plants or seeds that the producer sold or provided to them, the producer may replace the returned plants or seeds with an equal quantity that, taking into account the equivalency factor specified in subsection 145(2), does not exceed the equivalent of the maximum number of plants, determined in accordance with section 190, that are authorized to be under production under the client’s registration with the Minister made under Part 2.

DIVISION 3

Clients and Other Authorized Users

Return

148 (1) An individual who, in accordance with this Part or subsection 65(2.1) of the Narcotic Control Regulations, obtains fresh or dried marihuana or cannabis oil for their own medical purposes or for those of another individual for whom they are responsible may return the substance to the person who sold or provided it to them if that person accepts the return of the substance.

Marihuana plants or seeds

(2) A client registered on the basis of a registration with the Minister made under Part 2 who obtains marihuana plants or seeds for their own medical purposes, or the designated person of the client who obtains those plants or seeds for the medical purposes of the client, may return them to the licensed producer who sold or provided them to them if the producer accepts the return of the plants or seeds.

Return by shipping

(3) If the individual returns the substance by means of shipping it to the person who sold or provided it to them, they must

• (a) ship it in a package that, having regard to the substance being shipped, meets the requirements of paragraph 93(1)(b) or 93(3)(a); and
• (b) use a shipping method that meets the requirements of paragraph 93(1)(c).

Return to licensed producer

(4) If the individual returns the substance to the licensed producer who sold or provided it to them, they must do so by shipping it to the producer’s site in accordance with paragraphs (3)(a) and (b).

DIVISION 4

Sale or Provision by a Licensed Producer to a Person Other than a Client

Order required — cannabis

149 (1) A licensed producer must not sell or provide cannabis under subsection 22(2) unless the producer has first received a written order in accordance with subsection (3) from

• (a) in the case of a licensed dealer or another licensed producer, an individual who is authorized to place an order for cannabis on behalf of that dealer or producer; and
• (b) in any other case, the person to whom the cannabis is to be sold or provided in accordance with the Act and this Part.

Fresh or dried marihuana or cannabis oil

(2) A licensed producer must not sell or provide fresh or dried marihuana or cannabis oil under subparagraph 22(4)(a)(ii) or (iii) unless the producer has first received a written order in accordance with subsection (3) from

• (a) in the case referred to in subparagraph 22(4)(a)(ii), a pharmacist practising in the hospital or a health care practitioner authorized to place orders for that substance on behalf of the hospital; and
• (b) in the case referred to in subparagraph 22(4)(a)(iii), the person to whom that substance is to be sold or provided.

Requirements

(3) The written order must

• (a) be signed and dated by a person described in subsection (1) or (2) and indicate their name;
• (b) indicate the shipping address in Canada; and
• (c) specify the substance being ordered and include the following information:
  • (i) in the case of fresh or dried marihuana or cannabis oil, its quantity and brand name, or
  • (ii) in the case of cannabis other than cannabis referred to in subparagraph (i), its quantity, description and, if applicable, brand name.
    

Signature

(4) A licensed producer must verify in a reasonable manner the identity of the person who placed the order if the signature on the order is not known to the producer.

Definition — pharmacist

(5) In this section, pharmacist means a pharmacist as defined in section 2 of the Narcotic Control Regulations who is not named in a notice issued under section 48 of those Regulations that has not been retracted under section 49 of those Regulations.

Shipping

150 In filling an order referred to in subsection 149(2), a licensed producer must not transfer physical possession of the fresh or dried marihuana or cannabis oil to the person to whom it is sold or provided other than by shipping it to them.

Refusal

151 (1) A licensed producer must refuse to fill an order referred to in subsection 149(1) or (2) if

• (a) the order does not meet the requirements of subsection 149(3); or
• (b) in the circumstances described in subsection 149(4), the identity of the person cannot be verified.
  

Notice of refusal to fill order

(2) The licensed producer must send the person who placed the order a written notice of the reason for the refusal.

DIVISION 5

Record Keeping by Licensed Producers

Transactions

Cannabis received

152 Except in the case referred to in section 157, a licensed producer who receives cannabis must record the following information:

• (a) the name of the person from whom it was received;
• (b) the address of the site at which it was received;
• (c) the date on which it was received; and
• (d) an indication of which substance was received, as well as the following information:
  • (i) in the case of fresh or dried marihuana or cannabis oil, the quantity and, if applicable, brand name, or
  • (ii) in the case of cannabis other than cannabis referred to in subparagraph (i), its quantity, description, intended use and, if applicable, brand name.
    

Imported substances

153 A licensed producer who imports marihuana or a substance referred to in paragraph 22(3)(c) must retain a copy of the declaration required by section 98 and of the export permit issued by a competent authority in the country of export.

Exported substances

154 A licensed producer who exports marihuana or a substance referred to in paragraph 22(3)(c) must retain a copy of the declaration required by section 106 and of the import permit issued by a competent authority in the country of final destination.

Record of verbal order

155 A licensed producer who receives a verbal order referred to in subsection 143(3) must record the following information:

• (a) the date on which the order was placed and the order number;
• (b) the information referred to in paragraphs 143(2)(b) and (c); and
• (c) the name of the individual recording the order.

Filling of order from client

156 (1) A licensed producer who fills an order referred to in section 143 must record the following information:

• (a) the given name, surname and date of birth of the client for whom the order is placed;
• (b) the given name and surname of the individual placing the order;
• (c) the quantity, brand name and lot number of the fresh or dried marihuana, cannabis oil or marihuana plants or seeds sold or provided;
• (d) the date on which the order was received;
• (e) the date on which the substance was shipped; and
• (f) the address to which the substance was shipped.

Retention of documents

(2) A licensed producer must retain a written order referred to in subsection 143(2) or a written record of a verbal order referred to in subsection 143(3).

Refusal to fill an order

(3) A licensed producer who refuses to fill an order referred to in section 143 must retain a copy of the written notice referred to in subsection 145(3).

Returned substance

157 A licensed producer who receives fresh or dried marihuana, cannabis oil or marihuana plants or seeds that are returned under section 148 must record the following information:

• (a) the given name and surname of the client who returned the substance or on behalf of whom the substance was returned;
• (b) the address of the site at which it was received;
• (c) the name of the substance, its quantity and brand name; and
• (d) the date on which it was received.

Order from person other than client

158 (1) A licensed producer who fills an order referred to in subsection 149(1) or (2) must record the following information:

• (a) the name of the person to whom the substance was sold or provided;
• (b) the shipping address;
• (c) an indication of which substance was ordered, as well as the following information:
  • (i) in the case of fresh or dried marihuana or cannabis oil, its quantity and, if applicable, brand name, or
  • (ii) in the case of cannabis other than cannabis referred to in subparagraph (i), its quantity, description and, if applicable, brand name; and
• (d) the date on which the substance was shipped.

Refusal to fill an order

(2) A licensed producer who refuses to fill an order referred to in subsection 149(1) or (2) must retain a copy of the written notice referred to in subsection 151(2).

Client Registrations

Information

159 (1) A licensed producer must record the following information:

• (a) details of the verifications performed under subsection 121(2), section 132, subsection 135(2) and paragraph 139(2)(b); and
• (b) what will serve as the unique identifier referred to in paragraph 133(2)(b) and the manner in which and the date on which it was communicated to the client.
  

Documents

(2) A licensed producer must retain the following documents:

• (a) the registration application referred to in section 130;
• (b) the medical document referred to in section 130, or, if the document has been returned in accordance with subsection 136(3), a copy of it;
• (c) the copy of a registration certificate referred to in section 130;
• (d) a copy of a registration document referred to in paragraph 133(2)(a);
• (e) the application for the amendment of a registration referred to in section 137;
• (f) a copy of an amended registration document referred to in subsection 138(2); and
• (g) a copy of a notice referred to in section 136 or subsection 139(4) or (6).

Security, Production and Inventory

Security

160 A licensed producer must keep

• (a) the visual recordings referred to in sections 54 and 59;
• (b) the records referred to in subsections 56(2) and 62(2); and
• (c) the record referred to in subsection 57(3).

Good production practices and packaging, labelling and shipping

161 (1) A licensed producer must keep

• (a) records demonstrating that each lot or batch of fresh or dried marihuana, cannabis oil or marihuana plants or seeds that they sold or provided under subsection 22(4) or (5) was produced, packaged and labelled in accordance with Subdivisions D and F of Division 1;
• (b) a list of all brand names of fresh or dried marihuana, cannabis oil or marihuana plants or seeds that they produced, packaged or labelled;
• (c) a copy of the sanitation program referred to in section 72 in use at their site;
• (d) a copy of the standard operating procedures referred to in section 73 in use at their site;
• (e) documentation concerning the system of control referred to in section 74 in use at their site;
• (f) a description of the qualifications of the quality assurance person in respect of the matters referred to in subparagraph 75(1)(a)(ii); and
• (g) records of every complaint referred to in paragraph 75(1)(b) and of any corrective action taken.
  

Sale or provision

(2) A licensed producer who sells or provides fresh or dried marihuana, cannabis oil or marihuana plants or seeds must keep

• (a) records of any testing conducted by or on behalf of the licensed producer in respect of any lot or batch of the substance;
• (b) records of information necessary for the system of control referred to in section 74; and
• (c) a record of the information that the licensed producer is required by section 77 to provide to the Minister in respect of the recall of the substance.

Dried marihuana equivalency factor

162 A licensed producer must keep a record of the information concerning the method that they have used to determine the dried marihuana equivalency factor under section 79.

Lot or batch — marihuana

163 (1) A licensed producer must keep a record of the following information concerning each lot or batch of marihuana that they propagate, sow, harvest, dry, package or destroy:

• (a) the date on which marihuana plants are propagated by means other than sowing seeds and the number of new plants propagated in this manner;
• (b) the date on which marihuana seeds are sown and their net weight on that date;
• (c) the date on which marihuana is harvested and its net weight on that date;
• (d) the date on which the drying process for marihuana is completed, if any, and its net weight on that date;
• (e) the date on which marihuana is packaged and its net weight on that date; and
• (f) the date on which marihuana is destroyed and its net weight on that date, before the destruction.
  

Lot or batch — cannabis oil

(2) A licensed producer must keep a record of the following information concerning each lot or batch of cannabis oil that they produce, package or destroy:

• (a) the date on which the oil is produced and its net weight or volume on that date;
• (b) if applicable, the date on which the oil is put into a capsule or other similar dosage form and the number of capsules or units of that dosage form;
• (c) in respect of the cannabis that was used to produce the oil, its description, its net weight or volume, its lot or batch number and the date on which it was produced;
• (d) the date on which the oil is packaged and its net weight or volume on that date; and
• (e) the date on which the oil is destroyed and its net weight or volume on that date, before the destruction.
  

Research and development

164 Every licensed producer must keep a record of the following information concerning cannabis that they use in a research and development activity:

• (a) its description, the quantity used, its lot or batch number and, if applicable, its brand name;
• (b) the date on which it was used in that activity;
• (c) the purpose and a brief description of that activity;
• (d) in respect of any product or compound containing that cannabis that they have made or assembled in the course of that activity,
  • (i) its description,
  • (ii) the date on which it was made or assembled and the quantity made or assembled,
  • (iii) if applicable, the date on which it was used for testing and the quantity used, and
  • (iv) if applicable, the date on which it was placed in inventory and the quantity placed in inventory; and
• (e) any other details permitting the reconciliation of the quantity of cannabis referred to in paragraph (a) and the quantities of products or compounds referred to in paragraph (d).
  

Destroyed cannabis

165 (1) A licensed producer must keep, for each instance in which they destroy cannabis, a record of the following information:

• (a) the date on which the cannabis was destroyed, the name of the substance destroyed and its net weight on that date, before the destruction;
• (b) the location at which it was destroyed;
• (c) a brief description of the method of destruction;
• (d) the names of the witnesses to the destruction that are referred to in paragraph 30(1)(b) and the basis on which they are qualified to be witnesses under subsection 30(2); and
• (e) if applicable, the name of the person who accompanied the cannabis in accordance with subsection 30(3).

Statement by witnesses

(2) A licensed producer must keep, for each instance in which they destroy cannabis, a statement signed and dated by each of the witnesses referred to in paragraph 30(1)(b) stating that they have witnessed the destruction and that the cannabis was destroyed in accordance with section 30.

Inventory — marihuana

166 (1) A licensed producer must keep a record of the net weight of each of the following that are in inventory at their site at the end of each quarter of the calendar year:

• (a) marihuana seeds, other than marihuana seeds referred to in paragraph (h);
• (b) harvested marihuana, other than marihuana referred to in paragraphs (e) and (f), that is not to be subjected to a drying process;
• (c) harvested marihuana, other than marihuana referred to in paragraphs (e) and (g), in respect of which the drying process has not been completed;
• (d) harvested marihuana, other than marihuana referred to in paragraphs (e) and (g), in respect of which the drying process has been completed;
• (e) marihuana that is destined for destruction;
• (f) packaged fresh marihuana;
• (g) packaged dried marihuana;
• (h) packaged marihuana seeds; and
• (i) cannabis other than marihuana or cannabis oil, with an indication of the name and net weight of each of the substances in question.
  

Inventory — marihuana plants

(2) A licensed producer must keep a record of the number of marihuana plants destined to be sold or provided that are in inventory at their site at the end of each quarter of the calendar year.

Inventory — cannabis oil

(3) A licensed producer must keep a record of the net weight of each of the following that are in inventory at their site at the end of each quarter of the calendar year:

• (a) cannabis oil that has not been packaged, other than cannabis oil referred to in paragraph (c);
• (b) packaged cannabis oil, other than cannabis oil referred to in paragraph (c); and
• (c) cannabis oil that is destined for destruction.

Notices to Local Authorities

Notices

167 A licensed producer must keep a copy of

• (a) each notice provided to local authorities under sections 48 to 50; and
• (b) each copy of a notice provided to the Minister under section 50.

Communications with Licensing Authorities

Documents

168 A licensed producer must keep

• (a) a copy of each notice provided to a licensing authority under section 51, as well a copy of the copy of the notice provided to the Minister under that section;
• (b) for each request received from a licensing authority under subsection 123(1),
  • (i) a copy of the request, together with any supporting documentation received,
  • (ii) a record of the date on which the request and documentation were received,
  • (iii) a copy of the information that was provided in response to the request,
  • (iv) a record of the date on which the information was provided, and
  • (v) a record of the steps that were taken to ensure that the information was securely transmitted to the authority;
• (c) a copy of any request or notice received from a licensing authority under section 124 and a record of the date on which it was received;
• (d) for each instance in which they provide information to a licensing authority under section 124,
  • (i) a copy of the information,
  • (ii) a record of the date on which the information was provided, and
  • (iii) a record of the steps that were taken to ensure that the information was securely transmitted to the authority; and
• (e) a copy of the notice sent under subsection 124(5).
  

General Obligations

Manner of keeping records

169 (1) A licensed producer must ensure that the records, documents and information referred to in this Division are kept in a manner that will enable an audit of them to be made in a timely manner and are available at their site.

Retention period

(2) A licensed producer must retain the records, documents and information for the following periods:

• (a) in the case of a notice that the producer is required to provide or send under this Part, for a period of two years after the day on which the notice is provided or sent;
• (b) in the case of information that the producer is required to record under sections 152 and 155, subsection 156(1), section 157, subsections 158(1) and 159(1) and sections 163, 164 and 166, for a period of two years after the day on which the information is recorded;
• (c) in the case of the documents referred to in sections 153 and 154, for a period of two years after the day on which the declaration referred to in section 98 or 106, as applicable, is sent to the Minister;
• (d) in the case of the documents referred to in subsection 156(2) and paragraphs 159(2)(a) to (f), for a period of two years after the day on which the producer obtained them or, in the case of documents made by the producer, the day on which they were made;
• (e) in the case of the visual recordings or the records referred to in section 160, for a period of two years after the day on which they were made;
• (f) in the case of the records referred to in paragraphs 161(1)(a) and (2)(b), for a period of two years after the date of the last sale or provision of any portion of the lot or batch of fresh or dried marihuana, cannabis oil or marihuana plants or seeds under subsection 22(4) or (5);
• (g) in the case of a document referred to in any of paragraphs 161(1)(b) to (e), for the period during which it is current and for an additional period of two years after the day on which it is replaced by a new version;
• (h) in the case of a document referred to in paragraph 161(1)(f), for the period during which the quality assurance person acts in that capacity and for an additional period of two years after the day on which the person ceases to do so;
• (i) in the case of the records referred to in paragraph 161(1)(g), for a period of two years after the day on which the complaint was recorded;
• (j) in the case of the records referred to in paragraph 161(2)(a), for a period of two years after the date of the last sale or provision of any portion of the lot or batch, other than a sale or provision for destruction;
• (k) in the case of the records referred to in paragraph 161(2)(c), for a period of two years after the day on which the substance was recalled;
• (l) in the case of the information concerning the method referred to in section 162, for a period of two years after the day on which the information is recorded;
• (m) in the case of the records and documents referred to in section 165, for a period of two years after the day on which the cannabis was destroyed;
• (n) in the case of a document or record referred to in paragraph 168(b), for a period of two years after the day on which the information was provided to the licensing authority;
• (o) in the case of a request or notice referred to in paragraph 168(c), for a period of two years after the day on which it was received;
• (p) in the case of a document or record referred to in paragraph 168(d), for a period of two years after the day by which the producer was required to provide the information; and
• (q) in the case of a notice referred to in paragraph 168(e), for a period of two years after the end of the quarter to which the notice relates.

Case reports and summary reports

(3) A licensed producer must retain the serious adverse reaction case reports and the summary reports referred to in subsections 78(1) and (2), respectively, for a period of 25 years after the day on which they were made.

Information required by Minister

170 A licensed producer must provide the Minister with any information that the Minister may require in respect of the records, documents and information referred to in this Division, in the form and at the times that the Minister specifies.

Former licensed producers

171 If a producer’s licence expires without being renewed or is revoked, the former licensed producer must comply with the requirements of sections 169 and 170.

PART 2

Production for Own Medical Purposes and Production by a Designated Person

Interpretation

Definition

172 (1) In this Part, production area means the place where the production of marihuana plants is conducted, that is

• (a) entirely indoors;
• (b) entirely outdoors; or
• (c) partly indoors and partly outdoors.

Adjacent land

(2) For the purposes of paragraphs 177(4)(e) and 193(1)(d), a piece of land is considered to be adjacent to another piece of land if its boundary has at least one point in common with the boundary of the other piece of land.

General Provision

Signature and attestation

173 An application, declaration or notice that is required to be submitted under this Part by an applicant or registered person must be signed and dated by them — or an individual who is responsible for them — and attest that the information contained in it is correct and complete.

DIVISION 1

Registration with Minister

Eligibility – registered person

174 (1) An individual is eligible to be a registered person only if they ordinarily reside in Canada.

Eligibility – production for own medical purposes

(2) An individual is eligible to produce cannabis for their own medical purposes as a registered person only if they are an adult.

Prior offences

(3) An individual is not eligible to conduct the production referred to in subsection (2) if, within the preceding 10 years, they have been convicted, as an adult, of

• (a) a designated cannabis offence — or an offence committed outside Canada that, if committed in Canada, would have constituted such an offence — that was committed while they were authorized to produce cannabis under the Act, other than under the former Marihuana Medical Access Regulations; or
• (b) a designated marihuana offence — or an offence committed outside Canada that, if committed in Canada, would have constituted such an offence — that was committed while they were authorized to produce marihuana
  • (i) under the Act, other than under these Regulations, or
  • (ii) by virtue of an injunction order issued by a court.
    

Definitions

(4) The following definitions apply in this section.

designated cannabis offence means

• (a) an offence, in respect of cannabis, under section 5 of the Act, or under section 6 of the Act except with respect to importation; or
• (b) a conspiracy or an attempt to commit, or being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in paragraph (a). (infraction désignée relativement au chanvre indien)

designated marihuana offence means

• (a) an offence, in respect of marihuana, under section 5 of the Act, or under section 6 of the Act except with respect to importation; or
• (b) a conspiracy or an attempt to commit, or being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in paragraph (a). (infraction désignée relativement à la marihuana)
  

Eligibility — one registration only

175 An individual must not be registered more than once at any time.

Eligibility — designated person

176 (1) Subject to subsection (2), an individual is eligible to be a designated person only if they are an adult who ordinarily resides in Canada.

Prior offences

(2) An individual is not eligible to be a designated person if, within the preceding 10 years, they

• (a) have been convicted, as an adult, of a designated drug offence, as defined in section 2 of the Narcotic Control Regulations;
• (b) have been convicted, as an adult, of an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in paragraph (a);
• (c) have been convicted of an offence referred to in paragraph (a) as a young person in ordinary court, as those terms were defined in subsection 2(1) of the Young Offenders Act, chapter Y-1 of the Revised Statutes of Canada, 1985, immediately before that Act was repealed;
• (d) were a young person who received an adult sentence, as those terms are defined in subsection 2(1) of the Youth Criminal Justice Act, in respect of an offence referred to in paragraph (a); or
• (e) received a sentence — for an offence they committed outside Canada when they were at least 14 years old but less than 18 years old that, if committed in Canada, would have constituted an offence referred to in paragraph (a) — that was longer than the maximum youth sentence that could have been imposed under the Youth Criminal Justice Act for such an offence.

Registration application

177 (1) An individual seeking a registration to produce cannabis for their own medical purposes or to have it produced for them by a designated person must submit to the Minister an application that includes the original of the applicant’s medical document and the information and documents required by this section.

Responsible individual

(2) The application and related documents may also be submitted by an individual who is responsible for the applicant, in which case the application must be signed and dated by that individual and include a statement by them that they are responsible for the applicant.

Basic information

(3) The application must include

• (a) the applicant’s given name, surname, date of birth and gender;
• (b) the full address of the place where the applicant ordinarily resides, as well as the applicant’s telephone number and, if applicable, facsimile number and email address;
• (c) the mailing address of the place referred to in paragraph (b), if different from the address provided under that paragraph;
• (d) if applicable, the given name, surname, date of birth and gender of one or more individuals who are responsible for the applicant;
• (e) if the place referred to in paragraph (b) is an establishment that is not a private residence, the type and name of the establishment;
• (f) an indication that, as applicable,
  • (i) the applicant will comply with the possession limit referred to in section 6, or
  • (ii) any individual who is responsible for the applicant will comply with that limit and ensure that the applicant complies with it;
• (g) an indication as to whether the registration is sought in respect of cannabis to be produced by the applicant or by a designated person named in the application; and
• (h) an indication that the applicant or, if applicable, any individual who is responsible for the applicant will take all necessary measures to ensure the security of the cannabis in their possession.

Production for own medical purposes

(4) If the applicant intends to produce cannabis for their own medical purposes, the application must also include

• (a) an indication that, within the 10 years preceding the application, they have not been convicted, as an adult, of an offence referred to in paragraph 174(3)(a) or (b);
• (b) an indication that they will comply with the limit on the maximum number of plants under production referred to in paragraph 178(2)(l) and the limit on the maximum quantity of dried marihuana in storage referred to in paragraph 178(2)(n);
• (c) the full address of the site where the proposed production of marihuana plants is to be conducted;
• (d) the proposed production area;
• (e) if the proposed production area involves outdoor production entirely or partly indoor and partly outdoor production, an indication that the production site is not adjacent to a school, public playground, day-care facility or other public place frequented mainly by persons under 18 years of age;
• (f) an indication that the cannabis, other than marihuana plants, will be stored indoors and whether it is proposed to store it at
  • (i) the proposed site for the production of marihuana plants, or
  • (ii) the ordinary place of residence of the applicant, if different than the site referred to in subparagraph (i); and
• (g) an indication that the applicant will take all necessary measures to ensure the security of the marihuana plants and cannabis.
  

Production by designated person

(5) If the cannabis is to be produced by a designated person, the application must include a declaration by the designated person that includes

• (a) the information referred to in paragraphs (3)(a) to (c) and (e), in respect of the designated person;
• (b) the information referred to in paragraphs (4)(c) to (e);
• (c) an indication that the cannabis, other than marihuana plants, will be stored indoors and whether it is proposed to store it at
  • (i) the proposed site for the production of marihuana plants, or
  • (ii) the ordinary place of residence of the designated person, if different than the site referred to in subparagraph (i);
• (d) an indication that
  • (i) within the 10 years preceding the application, they have not been convicted of an offence referred to in any of paragraphs 176(2)(a) to (c) or received a sentence referred to in paragraph 176(2)(d) or (e),
  • (ii) that they will take all necessary measures to ensure the security of the marihuana plants and cannabis, and
  • (iii) they will comply with the limit on the maximum number of plants under production referred to in paragraph 178(2)(l) and the limit on the maximum quantity of dried marihuana in storage referred to in paragraph 178(2)(n); and
• (e) a document issued by a Canadian police force establishing that, within the 10 years preceding the application, the designated person has not been convicted of an offence referred to in paragraph 176(2)(a) or (c) or received a sentence referred to in paragraph 176(2)(d).
  

Signature and attestation of designated person

(6) The declaration referred to in subsection (5) must be signed and dated by the designated person and attest that the information contained in it is correct and complete.

Consent of owner

(7) If the proposed site for the production of marihuana plants is not the ordinary place of residence of the applicant or of the designated person, if any, and is not owned by the applicant or the designated person, the application must include the given name, surname, address and telephone number of the owner of the site and a declaration signed and dated by them consenting to production at the site.

Registration

178 (1) Subject to sections 183 to 185, if the requirements of section 177 are met, the Minister must register the applicant.

Content

(2) The registration must include

• (a) the given name, surname, date of birth and gender of the registered person and, if applicable, the designated person;
• (b) if applicable, the given name, surname, date of birth and gender of any individual who is responsible for the registered person;
• (c) the full address of the place where the registered person and, if applicable, the designated person, ordinarily resides;
• (d) the registration number;
• (e) the name of the health care practitioner who provided the medical document;
• (f) the maximum quantity of dried marihuana, in grams, that the registered person or, if applicable, any individual who is responsible for the registered person may possess under the registration, which is the lesser of
  • (i) 30 times the daily quantity of dried marihuana referred to in paragraph 8(1)(d), and
  • (ii) 150 g of dried marihuana;
• (g) the effective date of the registration;
• (h) the expiry date of the registration, which must correspond to the end of the period of validity of the medical document supporting the registration, as determined in accordance with subsection 8(3);
• (i) the type of production that is authorized, namely production for one’s own medical purposes or production by a designated person;
• (j) the full address of the site where the production of marihuana plants is authorized;
• (k) the authorized production area;
• (l) the maximum number of marihuana plants, determined in accordance with section 190, that may be under production at the production site and, if the production area is partly indoors and partly outdoors, the maximum number of plants for each production period;
• (m) the full address of the site where the cannabis may be stored; and
• (n) the maximum quantity of dried marihuana, in grams, determined in accordance with section 191, that may be stored at the site authorized under paragraph (m).

Documents

(3) The Minister must

• (a) send a registration certificate to the registered person; and
• (b) send to the designated person, if any, a document containing information relating to the production by the designated person.

Renewal application

179 To apply to renew a registration, the registered person or an individual who is responsible for them must submit to the Minister an application that includes the registration number and the information and documents required under section 177.

Renewal

180 (1) Subject to sections 183 to 185, if an application complies with section 179, the Minister must renew the registration and send the renewed registration certificate to the registered person and send to the designated person, if any, an updated version of the document referred to in paragraph 178(3)(b).

Cancellation of existing registration

(2) Before renewing the registration, the Minister must cancel any existing registration .

Notice to former designated person

(3) If a registration is renewed before the expiry of the previous registration and the renewal results in the replacement of a designated person by another or by the registered person, the Minister must notify the former designated person of the loss of their authorization to produce cannabis under that registration.

Amendment application

181 (1) Subject to subsection (3), the registered person or an individual who is responsible for them must submit to the Minister an amendment application in respect of a change to any of the information set out in the registration.

Content

(2) The application must include

• (a) the registration number;
• (b) in respect of the proposed amendment,
  • (i) a description of it and the supporting reasons for it,
  • (ii) the information and documents mentioned in section 177 that are relevant to it, and
  • (iii) the date on which it is to take effect; and
• (c) in the case of a change in the given name or surname of the registered person, the designated person or an individual who is responsible for the registered person, proof of the change.

New application concerning new medical document

(3) In the case of a new medical document, a new registration application must be submitted under section 177.

Amendment

182 (1) Subject to sections 183 to 185, if an application complies with section 181, the Minister must amend the registration and, if applicable, send an amended registration certificate to the registered person and send to the designated person, if any, an updated version of the document referred to in paragraph 178(3)(b).

Notice to former designated person

(2) If the amendment results in the replacement of a designated person by another or by the registered person, the Minister must notify the former designated person of the loss of their authorization to produce cannabis under that registration.

Change of site

(3) If the Minister amends a registration in respect of a change in the location of the authorized site for the production of marihuana plants or the authorized site for the storage of cannabis, the Minister may specify the period during which the registered person or the designated person, if any, may transport cannabis from the former site to the new site.

Grounds for refusal — registration

183 The Minister must refuse to register an applicant or renew or amend a registration if

• (a) the applicant is not eligible under subsection 174(1) or section 175;
• (b) the medical document that supports the application does not meet all of the requirements of section 8 or is no longer valid;
• (c) the person who provided the applicant with the medical document
  • (i) is not a health care practitioner,
  • (ii) is not entitled to practise their profession in the province in which the applicant consulted with that person, or
  • (iii) is named in a notice issued under section 59 of the Narcotic Control Regulations that has not been retracted under section 60 of those Regulations;
• (d) the given name, surname or date of birth of the applicant is different from the given name, surname or date of birth that appears on the medical document;
• (e) the health care practitioner who provided the medical document to the applicant notifies the Minister in writing that the use of dried marihuana by the applicant is no longer supported for clinical reasons; or
• (f) any information, declaration or other item included in the application is false or misleading.
  

Grounds for refusal — production for own medical purposes

184 In the case of an application for a registration to produce for own’s own medical purposes or an application to renew or amend such a registration, the Minister must refuse to register the applicant or to renew or amend the registration if

• (a) the person is not eligible under subsection 174(2) or (3);
• (b) the person would become authorized to produce marihuana plants under more than two registrations;
• (c) the proposed site for the production of marihuana plants would be a production site under more than four registrations; or
• (d) any information, declaration or other item included in the application is false or misleading.

Grounds for refusal — designated person

185 In the case of an application for a registration for production by a designated person or an application to renew or amend such a registration, the Minister must refuse to register the applicant or to renew or amend the registration

• (a) if the person is not eligible under section 176; or
• (b) for any reason referred to in paragraphs 184(b) to (d).
  

Notice of refusal

186 If the Minister proposes to refuse to register an applicant or to renew or amend a registration under any of sections 183 to 185, the Minister must

• (a) notify the applicant in writing of the reason for the proposed refusal; and
• (b) give the applicant an opportunity to be heard.

DIVISION 2

Production

Authorized Activities

Registered person — production for own medical purposes

187 A registered person whose registration authorizes them to produce cannabis for their own medical purposes may, in accordance with their registration and the provisions of this Part,

• (a) produce for their own medical purposes marihuana plants or cannabis other than marihuana plants;
• (b) store, for their own medical purposes, a quantity of cannabis not exceeding the equivalent of the maximum quantity of dried marihuana that may be stored under the registration;
• (c) transport directly, from the site for the storage of cannabis to the site for the production of marihuana plants, a total quantity of marihuana plants and seeds that, taking into account the equivalency factor specified in subsection 145(2), does not exceed the equivalent of the maximum number of plants, determined in accordance with section 190, that are authorized to be under production under the registration;
• (d) if the site for the production of marihuana plants is different from the place where the registered person ordinarily resides, transport directly from that site to that place a quantity of cannabis not exceeding the equivalent of the maximum quantity of dried marihuana that may be stored under the registration; and
• (e) if there is a change in the location of the site for the production of marihuana plants or the site for the storage of cannabis, transport cannabis directly from the former site to the new site.
  

Registered person who has a designated person

188 A registered person whose registration specifies a designated person may, if they are an adult, participate in the activities that the designated person is authorized to conduct under the registration.

Designated person

189 (1) A designated person may, in accordance with the registration and the provisions of this Part,

• (a) produce, for the medical purposes of the registered person, marihuana plants or cannabis other than marihuana plants;
• (b) store, for the purpose mentioned in paragraph (a), a quantity of cannabis not exceeding the equivalent of the maximum quantity of dried marihuana that may be stored under the registration;
• (c) transport directly, from the site for the storage of cannabis to the site for the production of marihuana plants, a total quantity of marihuana plants and seeds that, taking into account the equivalency factor specified in subsection 145(2), does not exceed the equivalent of the maximum number of plants, determined in accordance with section 190, that are authorized to be under production under the registration;
• (d) if the site for the production of marihuana plants is different from the site for the storage of cannabis, transport directly from the first to the second site a quantity of cannabis not exceeding the equivalent of the maximum quantity of dried marihuana that may be stored under the registration;
• (e) subject to subsection (2), if the site for the storage of cannabis is different from the place where the registered person ordinarily resides, transport directly or ship from that site to that place a quantity of cannabis not exceeding the equivalent of the maximum quantity of dried marihuana that the registered person may possess under paragraph 178(2)(f);
• (f) if there is a change in the location of the site for the production of marihuana plants or the site for the storage of cannabis, transport cannabis directly from the former site to the new site; and
• (g) provide or deliver for the registered person a quantity of cannabis not exceeding the equivalent of the maximum quantity of dried marihuana that the registered person may possess under paragraph 178(2)(f).
  

Security when shipping

(2) A designated person shipping cannabis in the circumstances referred to in paragraph (1)(e) must take the measures specified in paragraphs 93(1)(b) and (c).

General Provisions

Maximum number of plants under production

190 (1) In the formulas in subsection (2),

• A is the daily quantity of dried marihuana, expressed in grams, indicated in the medical document;
• C is a constant equal to 1, representing the growth cycle of a marihuana plant from seeding to harvesting; and
• D is the maximum number of marihuana plants that may be under production at the site for the production of marihuana plants under the registration.

Calculation

(2) The maximum number of marihuana plants is determined according to whichever of the following formulas applies:

• (a) if the production area is entirely indoors,

D = [(A × 365) ÷ (B × 3C)] × 1.2

where

• B is 30 grams, being the expected yield of dried marihuana per plant;
• (b) if the production area is entirely outdoors,

D = [(A × 365) ÷ (B × C)] × 1.3

where

• B is 250 grams, being the expected yield of dried marihuana per plant; and
• (c) if the production area is partly indoors and partly outdoors,
  • (i) for the indoor period

D = [(A × 182.5) ÷ (B × 2C)] × 1.2

where

• B is 30 grams, being the expected yield of dried marihuana per plant, and
• (ii) for the outdoor period

D = [(A × 182.5) ÷ (B × C)] × 1.3

where

• B is 250 grams, being the expected yield of dried marihuana per plant.

Rounding

(3) If the number determined for D is not a whole number, it is to be rounded to the next highest whole number.

Maximum quantity of dried marihuana in storage

191 (1) In the formulas in subsection (2),

E is

• (a) if the production area is entirely indoors or outdoors, the maximum number of marihuana plants that the registered person or designated person is authorized to produce, calculated under paragraph 190(2)(a) or (b), whichever applies, or
• (b) if the production area is partly indoors and partly outdoors, the maximum number of marihuana plants that the registered person or designated person is authorized to produce, calculated under subparagraph 190(2)(c)(ii); and

F is the maximum quantity of dried marihuana, in grams, that may be stored under the registration.

Calculation

(2) The maximum quantity of dried marihuana that may be stored under the registration is determined according to whichever of the following formulas applies:

• (a) if the production area is entirely indoors,

F = E × B × 1.5

where

• B is 30 grams, being the expected yield of dried marihuana per plant;
• (b) if the production area is entirely outdoors,

F = E × B × 1.5

where

• B is 250 grams, being the expected yield of dried marihuana per plant: and
• (c) if the production area is partly indoors and partly outdoors,

F = E × B × 1.5

where

• B is 250 grams, being the expected yield of dried marihuana per plant.

Maximum quantity of cannabis in storage

192 A person who is authorized by a registration to produce cannabis must not store a total quantity of fresh marihuana, dried marihuana and any products referred to in paragraphs 4(1)(b) and (c) that exceeds the equivalent of the maximum quantity of dried marihuana that may be stored under the registration, as calculated under section 191.

Location and type of production

193 (1) A person who is authorized by a registration to produce cannabis

• (a) may only produce marihuana plants at the authorized site for the production of marihuana plants;
• (b) may only produce cannabis, other than marihuana plants, at the site for the production of marihuana plants or at the site for the storage of cannabis;
• (c) must not cultivate, harvest or propagate marihuana partly indoors and partly outdoors simultaneously; and
• (d) must not cultivate, harvest or propagate marihuana outdoors if the production site is adjacent to a school, public playground, day-care facility or other public place frequented mainly by persons under 18 years of age.
  

Exception

(2) A registered person or an individual responsible for them may produce a quantity of cannabis, other than marihuana plants, at a location other than one specified in paragraph (1)(b) if the quantity produced does not exceed the equivalent of the maximum quantity of dried marihuana that they may possess under paragraph 178(2)(f).

Transport of plants

(3) If marihuana plants are shipped by a licensed producer to the site for the storage of cannabis, the person who is authorized by the registration to produce cannabis must transport the plants directly from that site to the site for the production of marihuana plants within seven days after the day on which the plants are received.

Storage at specified site

194 A person who is authorized by a registration to produce cannabis may store cannabis, other than marihuana plants, only indoors at the site authorized in the registration for that purpose.

Inspection

195 (1) To verify that the production of cannabis is in accordance with these Regulations and a registration, an inspector may, at any reasonable time, enter any place where the inspector believes on reasonable grounds that cannabis is being produced or stored by a registered person or a designated person, and may, for that purpose,

• (a) open and examine any receptacle or package found there that could contain cannabis;
• (b) examine anything found there that is used or may be capable of being used to produce or store cannabis;
• (c) examine any substance found there and, for the purpose of analysis, take samples; and
• (d) seize and detain, in accordance with Part IV of the Act, any substance found there, if the inspector believes, on reasonable grounds, that it is necessary.
  

Consent

(2) An inspector may not enter a dwelling place without the consent of an occupant of the dwelling place.

Provisions of the Act

(3) Subsections 31(6) to (9) of the Act apply, with the necessary modifications, to an inspection under this section.

DIVISION 3

General Obligations

Security

196 (1) A registered person or, if applicable, an individual who is responsible for them must maintain measures necessary to ensure the security of the cannabis in their possession and the registration certificate.

Reporting loss or theft

(2) In the case of the loss or theft of cannabis or the registration certificate, the registered person or the individual who is responsible for them must

• (a) within the 24 hours after becoming aware of the occurrence, notify a police force; and
• (b) within the next 72 hours after becoming aware of the occurrence, notify the Minister, in writing, and include confirmation that the notice required under paragraph (a) has been given.

Designated person

(3) The requirements specified in subsections (1) and (2) also apply to a designated person in regard to cannabis in their possession and the document referred to in paragraph 178(3)(b).

Cancellation of registration

197 (1) Subject to section 198, the Minister must cancel a registration if

• (a) the registered person is not eligible under section 174;
• (b) the designated person is not eligible under section 176;
• (c) the registered person or designated person has contravened section 193;
• (d) the registration was issued on the basis of false or misleading information;
• (e) the health care practitioner who provided the medical document to the registered person notifies the Minister in writing that the use of dried marihuana by the person is no longer supported for clinical reasons;
• (f) the health care practitioner who provided the medical document to the registered person is named in a notice issued under section 59 of the Narcotic Control Regulations that has not been retracted under section 60 of those Regulations;
• (g) the registered person or an individual who is responsible for them requests the Minister to cancel the registration; or
• (h) the registered person dies or ceases to ordinarily reside in Canada.

Cancelling excess registrations

(2) Subject to section 198, if a site for the production of marihuana plants is authorized under more than four registrations, the Minister must cancel the excess registrations.

Communication to licensed producer

(3) If a registration is cancelled and the Minister is aware that the registration has formed the basis for registering with a licensed producer under Part 1, the Minister must notify the producer of the cancellation and provide them with the following information:

• (a) the given name and surname of the person named in the cancelled registration;
• (b) the person’s date of birth;
• (c) the registration number of the cancelled registration; and
• (d) the date of the cancellation.

Effect of cancellation

(4) For greater certainty, if a registration is cancelled, the production of cannabis under the registration ceases to be authorized.

Notice of cancellation

198 The Minister must not cancel a registration , unless

• (a) the Minister has sent the registered person a notice of the reasons for the proposed cancellation and has given them an opportunity to be heard;
• (b) the Minister has sent the designated person, if any, a notice of the proposed cancellation; and
• (c) the failure that gave rise to the proposed cancellation is not rectified.

Destruction of cannabis — registered person

199 (1) A registered person who ceases to be authorized to produce marihuana plants under their registration must discontinue production of those plants and, subject to subsection (2), destroy all cannabis in their possession.

Exception

(2) The registered person is not required to destroy cannabis that is not in excess of the equivalent of the maximum quantity of dried marihuana that they may possess under paragraph 178(2)(f).

Destruction of cannabis — designated person

200 (1) A designated person who ceases to be authorized to produce cannabis under a registration must discontinue production of cannabis and, subject to subsection (2), destroy all cannabis in their possession.

Exception

(2) The person may, before destroying cannabis, transport, transfer, give or deliver, without delay, directly to the registered person, or an individual who is responsible for them, a quantity of cannabis not exceeding the equivalent of the maximum quantity of dried marihuana that the registered person may possess under paragraph 178(2)(f).

Destruction of cannabis — change in production area

201 If a registration is amended under section 182 or at the time of the renewal to reflect a change in the production area, the person authorized to produce cannabis must destroy

• (a) any marihuana plants under production that are in excess of the maximum number of plants that may be produced under the registration, as amended; and
• (b) any cannabis that they are storing that is in excess of the equivalent of the maximum quantity of dried marihuana that may be stored under the registration, as amended.

Communication of information – police

202 The Minister is authorized to provide any of the following information to a Canadian police force or a member of a Canadian police force who requests the information in the course of an investigation under the Act or these Regulations, subject to that information being used only for the purposes of that investigation and the proper administration or enforcement of the Act or these Regulations:

• (a) in respect of a named individual, whether the individual is a registered person, a designated person or an individual who is responsible for the registered person;
• (b) in respect of a specified address, whether the address is
  • (i) the place where a registered person or a designated person ordinarily resides and, if so, the name of that person and the registration number,
  • (ii) the site where the production of marihuana plants is authorized under a registration and, if so, the registration number, the name of the person who is authorized to produce and, if that person is a designated person, the name of the registered person who may participate in the production, or
  • (iii) the site where cannabis may be stored under a registration and, if so, the information referred to in subparagraph (ii); and
• (c) in respect of a registration,
  • (i) the given name, surname, date of birth and gender of the registered person, the designated person, if any, and the individuals who are responsible for the registered person, if any,
  • (ii) the full address of the place where the registered person and the designated person, if any, ordinarily reside,
  • (iii) the registration number,
  • (iv) the maximum quantity of dried marihuana that the registered person may possess under paragraph 178(2)(f),
  • (v) its effective date and expiry date,
  • (vi) if the registration has expired, whether an application to renew it has been made before the date of expiry and the status of the application,
  • (vii) the full address of the site where the production of marihuana plants is authorized,
  • (viii) the authorized production area,
  • (ix) the maximum number of marihuana plants that may be under production at the production site,
  • (x) the full address of the site where cannabis may be stored, and
  • (xi) the maximum quantity of dried marihuana that may be stored at the site referred to in subparagraph (x).
    

Communication of information — licensing authorities

203 (1) The Minister is authorized to provide, in respect of a health care practitioner who provided a medical document that formed the basis for a registration with the Minister, the following information to the provincial professional licensing authority that is responsible for the registration or authorization of persons to practise their profession in the province identified in the document as the province in which the practitioner is authorized to practise:

• (a) the given name, surname and date of birth of the person who registered with the Minister;
• (b) the postal code for, and the name of the province specified in, the address of the place where the registered person ordinarily resides;
• (c) the given name, surname and business address of the health care practitioner who signed the medical document and the number assigned by the province to the practitioner’s authorization to practise;
• (d) the daily quantity of dried marihuana that is specified in the medical document;
• (e) the period of use that is specified in the medical document; and
• (f) the date on which the medical document was signed by the health care practitioner.

Definition of health care practitioner

(2) In this section, health care practitioner has the same meaning as in section 122.

[204 to 253 reserved]

PART 3

Transitional Provisions

Definition of Licensed Producers Exemption

254 In this Part, Licensed Producers Exemption means the Section 56 Class Exemption for Licensed Producers Under the Marihuana for Medical Purposes Regulations to Conduct Activities with Cannabis issued by the Minister on July 8, 2015.

Licences and permits continued

255 (1) A producer’s licence or an import or export permit issued under the former Marihuana for Medical Purposes Regulations is continued under these Regulations and remains valid until it expires or is revoked.

Supplemental licences continued

(2) A supplemental licence issued in relation to the Licensed Producers Exemption is deemed to be continued under these Regulations as a producer’s licence and remains valid until it expires or is revoked.

Security clearances continued

(3) A security clearance granted under the former Marihuana for Medical Purposes Regulations is continued under these Regulations and remains valid until it expires or is cancelled.

Client registrations continued

(4) A registration of a client with a licensed producer under the former Marihuana for Medical Purposes Regulations is continued under these Regulations and remains valid until it expires or is cancelled.

Decisions by Minister

256 A decision made by the Minister under the former Marihuana for Medical Purposes Regulations continues to have effect for the purposes of these Regulations.

Packaging and labelling — dried marihuana

257 A licensed producer who sells or provides dried marihuana under subsection 22(4) may, during the 180-day period after the day on which these Regulations come into force, comply with the packaging and labelling provisions of the former Marihuana for Medical Purposes Regulations instead of those of these Regulations.

Packaging and labelling — fresh marihuana or cannabis oil

258 A licensed producer who sells or provides fresh marihuana or cannabis oil under subsection 22(4) may, during the 180-day period after the day on which these Regulations come into force, comply with the packaging and labelling provisions of the Licensed Producers Exemption instead of those of these Regulations.

Sale or provision of marihuana plants or seeds

259 If a producer’s licence that authorizes the sale or provision of dried marihuana was issued under the former Marihuana for Medical Purposes Regulations and is continued under these Regulations, the licensed producer may, pursuant to that licence and in accordance with these Regulations, sell or provide marihuana plants or seeds under section 22(5) of these Regulations until the earlier of

• (a) the 180th day after the day on which these Regulations come into force, and
• (b) the expiry, suspension or revocation of the licence.
  

Licence and permit applications

260 (1) If any of the following applications has been submitted under the former Marihuana for Medical Purposes Regulations but the Minister has not made a decision to approve or refuse the application before the day on which these Regulations come into force, it must be processed as an application under these Regulations:

• (a) an application for a producer’s licence or an application to renew or amend a producer’s licence;
• (b) an application for an import or export permit; or
• (c) an application for the approval of a change of personnel under paragraph 30(1)(a) of the Marihuana for Medical Purposes Regulations.
  

Supplemental licence applications

(2) If an application for a supplemental licence or an application to renew or amend a supplemental licence in relation to the Licensed Producers Exemption has been submitted but the Minister has not made a decision to approve or refuse the application before the day on which these Regulations come into force, it must be processed as an application under these Regulations to amend the producer’s licence to which it relates.

Applications for security clearances

(3) If an application for a security clearance has been submitted under the former Marihuana for Medical Purposes Regulations but the Minister has not made a decision to approve or refuse the application before the day on which these Regulations come into force, it must be processed as an application under these Regulations.

PART 4

Consequential Amendments, Repeal, Application and Coming into Force

Consequential Amendments

Narcotic Control Regulations

261 (1) The definitions former marihuana Regulations and medical marihuana document in subsection 2(1) of the Narcotic Control Regulations (see footnote 1) are repealed.

(2) The definition dried marihuana in subsection 2(1) of the Regulations is replaced by the following:

• dried marihuana has the same meaning as in subsection 1(1) of the Access to Cannabis for Medical Purposes Regulations; (marihuana séchée)

(3) Subsection 2(1) of the Regulations is amended by adding the following in alphabetical order:

• cannabis medical document has the meaning assigned by the definition medical document in subsection 1(1) of the Access to Cannabis for Medical Purposes Regulations; (document médical concernant le chanvre indien)
• cannabis oil has the same meaning as in subsection 1(1) of the Access to Cannabis for Medical Purposes Regulations; (huile de chanvre indien)
• former Marihuana for Medical Purposes Regulations means the regulations made by Order in Council P.C. 2013-645 of June 6, 2013 and registered as SOR/2013-119; (ancien Règlement sur la marihuana à des fins médicales)
• former Marihuana Medical Access Regulations means the regulations made by Order in Council P.C. 2001-1146 of June 14, 2001 and registered as SOR/2001-227; (ancien Règlement sur l’accès à la marihuana à des fins médicales).
• fresh marihuana has the same meaning as in subsection 1(1) of the Access to Cannabis for Medical Purposes Regulations; (marihuana fraîche)

262 Section 2.1 of the Regulations is repealed.

263 Subparagraph 3(1)(d)(iv) of the Regulations is replaced by the following:

• (iv) pursuant to a cannabis medical document that is not provided or obtained in contravention of the Access to Cannabis for Medical Purposes Regulations;

264 Subsection 8(4) of the Regulations is repealed.

265 Paragraph 9.4(1)(d.1) of the Regulations is replaced by the following:

• (d.1) an activity for which the licence is requested is the cultivation, propagation or harvesting of marihuana other than for scientific purposes;

266 (1) The portion of subsection 24(2) of the Regulations before paragraph (a) is replaced by the following:

(2) Subject to section 25, a licensed dealer may sell or provide any narcotic other than methadone to

(2) Subsection 24(2.2) of the Regulations is replaced by the following:

(2.2) No licensed dealer shall sell or provide dried marihuana to any person referred to in paragraphs (2)(b) to (d).

267 The portion of section 30 of the Regulations before paragraph (a) is replaced by the following:

30 A pharmacist who receives a narcotic from a licensed dealer or fresh or dried marihuana or cannabis oil from a licensed producer shall immediately enter the following in a book, register or other record maintained for such purposes:

268 (1) The portion of subsection 31(2) of the Regulations before paragraph (a) is replaced by the following:

(2) A pharmacist may sell or provide a narcotic — other than fresh or dried marihuana or cannabis oil received from a licensed producer or methadone — to a person

(2) Subsection 31(4) of the Regulations is replaced by the following:

(4) If authorized by the person in charge of the hospital, a pharmacist practising in a hospital may sell, provide or return fresh or dried marihuana or cannabis oil received from a licensed producer in accordance with subsection 65(2.1) or (3.1) or section 65.3.

269 (1) The portion of subsection 53(2) of the Regulations before paragraph (a) is replaced by the following:

(2) Subject to subsections (3) and (4), a practitioner may administer a narcotic — other than fresh or dried marihuana or cannabis oil received from a licensed producer — to a person or animal, or prescribe, sell or provide it for a person or animal, if

(2) Subsection 53(5) of the Regulations is replaced by the following:

(5) A health care practitioner may administer fresh or dried marihuana or cannabis oil received from a licensed producer to a person or prescribe or transfer it for a person if

• (a) the person is a patient under their professional treatment; and
• (b) the substance is required for the condition for which the person is receiving treatment.

270 The portion of subsection 54(1) of the Regulations before paragraph (a) is replaced by the following:

54 (1) A practitioner who sells or provides a narcotic — other than fresh or dried marihuana or cannabis oil received from a licensed producer — to a person for self-administration or for administration to an animal shall, whether or not the practitioner charges for the narcotic, keep a record showing the name and quantity of the narcotic sold or provided, the name and address of the person to whom it was sold or provided and the date on which it was sold or provided, if the quantity of the narcotic exceeds

271 Subparagraph 55(a)(iii) of the Regulations is replaced by the following:

• (iii) the cannabis medical documents provided by the health care practitioner;

272 (1) The portion of subsection 57(1) of the Regulations before paragraph (a) is replaced by the following:

57 (1) The Minister must provide in writing factual information about a practitioner that has been obtained under the Act, these Regulations, the Access to Cannabis for Medical Purposes Regulations, the former Marihuana for Medical Purposes Regulations or the former Marihuana Medical Access Regulations to the provincial professional licensing authority that is responsible for the registration or authorization of persons to practise the profession

(2) Clauses 57(1)(a)(ii)(B) and (C) of the Regulations are replaced by the following:

• (B) has been found guilty in a court of law of a designated drug offence or of a contravention of these Regulations, the Access to Cannabis for Medical Purposes Regulations or the former Marihuana for Medical Purposes Regulations, or
• (C) has contravened a provision of these Regulations, the Access to Cannabis for Medical Purposes Regulations or the former Marihuana for Medical Purposes Regulations; or
  

(3) The portion of subsection 57(2) of the Regulations before paragraph (a) is replaced by the following:

(2) The Minister is authorized to provide, in respect of a practitioner of medicine who made a medical declaration that formed the basis for the issuance of an authorization to possess under the former Marihuana Medical Access Regulations, the following information to the provincial professional licensing authority that is responsible for the registration or authorization of persons to practise medicine in the province identified in the declaration as the province in which the practitioner is authorized to practise:

273 Paragraph 58(e) of the Regulations is replaced by the following:

• (e) if that practitioner is a health care practitioner, the notified licensed producers must not sell or provide fresh or dried marihuana or cannabis oil on the basis of a cannabis medical document provided by that practitioner.

274 (1) Paragraph 59(1)(a.1) of the Regulations is replaced by the following:

• (a.1) if the practitioner named in the notice is a health care practitioner, the notified licensed producers must not ship fresh or dried marihuana or cannabis oil to that practitioner;

(2) Paragraph 59(1)(c) of the Regulations is replaced by the following:

• (c) if the practitioner named in the notice is a health care practitioner, the notified licensed producers must not sell or provide fresh or dried marihuana or cannabis oil on the basis of a cannabis medical document provided by that practitioner.
  

(3) Paragraph 59(6)(b) of the Regulations is replaced by the following:

• (b) a nurse practitioner within the meaning of section 1 of the New Classes of Practitioners Regulations who is permitted to prescribe fresh or dried marihuana or cannabis oil in the province in which they practise.
  

275 Subparagraphs 63(a)(viii) to (x) of the Regulations are replaced by the following:

• (viii) the name of the health care practitioner providing a cannabis medical document, the date on which the document was signed and the daily quantity and period of use specified in it,
• (ix) details concerning the return of fresh or dried marihuana or cannabis oil under paragraph 65.3(a) — namely, the name of the substance, the quantity returned, the name and address of the licensed producer to whom it was returned and the date on which it was returned, and
• (x) details concerning the sale or provision of fresh or dried marihuana or cannabis oil for destruction under paragraph 65.3(b) or (c) — namely, the name of the substance, the quantity sold or provided, the name and address of the licensed producer or licensed dealer to whom it was sold or provided and the date on which it was sold or provided;
  

276 (1) Subsections 65(2) to (4) of the Regulations are replaced by the following:

(2) Subject to subsection (5), on receipt of a prescription or a written order, signed and dated by a practitioner, the person in charge of a hospital may permit a narcotic — other than fresh or dried marihuana or cannabis oil received from a licensed producer — to be administered to a person or an animal under treatment as an in-patient or out-patient of the hospital, or to be sold or provided for the person or to the person in charge of the animal.

(2.1) On receipt of a prescription, a written order or a cannabis medical document, signed and dated by a health care practitioner, the person in charge of a hospital may permit fresh or dried marihuana or cannabis oil received from a licensed producer

• (a) to be administered to a person under treatment as an in-patient or out-patient of the hospital or to be sold or provided to that person; or
• (b) to be sold or provided to an individual who is responsible for that person.
  

(3) Subject to subsections (5) and (5.1), the person in charge of a hospital may permit a narcotic — other than fresh or dried marihuana or cannabis oil received from a licensed producer — to be provided, for emergency purposes, to a hospital employee or practitioner in another hospital on receipt of a written order signed and dated by a pharmacist in the other hospital or a practitioner authorized by the person in charge of the other hospital to sign the order.

(3.1) Subject to subsection (5.2), the person in charge of a hospital may permit fresh or dried marihuana or cannabis oil received from a licensed producer to be provided, for emergency purposes, to a hospital employee or health care practitioner in another hospital on receipt of a written order signed and dated by a pharmacist in the other hospital or a health care practitioner authorized by the person in charge of the other hospital to sign the order.

(4) Subject to subsection (5.1), the person in charge of a hospital may permit a narcotic — other than fresh or dried marihuana or cannabis oil received from a licensed producer — to be sold or provided, for emergency purposes, to a pharmacist on receipt of a written order signed and dated by the pharmacist.

(2) Subsection 65(5.2) of the Regulations is replaced by the following:

(5.2) No person in charge of a hospital shall permit fresh or dried marihuana or cannabis oil to be sold or provided under subsection (3.1) unless the signature of the pharmacist in the other hospital or of the health care practitioner authorized by the person in charge of the other hospital to sign an order is known to the person who sells or provides the substance or has been verified.

277 Sections 65.1 to 65.3 of the Regulations are replaced by the following:

65.1 (1) The person in charge of a hospital who permits fresh or dried marihuana or cannabis oil to be sold or provided under subsection 65(2.1) to an out-patient or an individual responsible for that patient shall ensure that, taking into account the dried marihuana equivalency factor determined under section 79 of the Access to Cannabis for Medical Purposes Regulations,

• (a) in a 30-day period the total quantity of the substance that is sold or provided to that person does not exceed the equivalent of 30 times the daily quantity referred to in subparagraph 65.2(c)(iii); and
• (b) the quantity of the substance that is sold or provided to that person at any one time does not exceed the equivalent of 150 g of dried marihuana.
  

(2) For the purposes of subsection (1), 30-day period means

• (a) the 30-day period beginning on the day on which a substance is first sold or provided to the out-patient or the individual responsible for that patient; and
• (b) every 30-day period after the period referred to in paragraph (a).
  

(3) For the purpose of applying subsection (2), the first 30-day period begins on the day on which a substance is first sold or provided to the out-patient or the individual responsible for that patient after the day on which that subsection comes into force, even if a substance was previously sold or provided to them.

(4) If the person to whom the substance is sold or provided as described in subsection (1) returns it to the hospital, the person in charge of the hospital may, subject to paragraph (1)(b), permit it to be replaced with an equal quantity of the substance.

(5) The quantity of the substance that is replaced under subsection (4) is to be excluded for the purpose of calculating the total quantity referred to in paragraph (1)(a).

65.2 The person in charge of a hospital who permits fresh or dried marihuana or cannabis oil to be sold or provided under subsection 65(2.1) to an out-patient or an individual responsible for that patient shall ensure that

• (a) the substance is sold or provided in the immediate container in which it was sold or provided by a licensed producer to an employee of the hospital referred to in subparagraph 22(4)(a)(ii) of the Access to Cannabis for Medical Purposes Regulations;
• (b) the immediate container bears the label required under section 84 of those Regulations;
• (c) a separate label is affixed to the immediate container that contains the following information:
  • (i) the given name, surname and profession of the health care practitioner who signed and dated the prescription, written order or cannabis medical document,
  • (ii) the given name and surname of the patient,
  • (iii) the daily quantity of dried marihuana, expressed in grams, that is authorized for the patient, as specified in the prescription, written order or cannabis medical document, and
  • (iv) the date on which the substance was sold or provided;
• (d) the label required under paragraph (c) does not cover any portion of the label referred to in paragraph (b);
• (e) the patient is provided with a copy of the current version of the document entitled Consumer Information — Cannabis (Marihuana, marijuana), published by the Department of Health; and
• (f) the patient is provided with a separate document containing the information referred to in paragraph (c).
  

65.3 The person in charge of a hospital may, on receiving a written order for fresh or dried marihuana or cannabis oil, permit it to be

• (a) returned to the licensed producer who sold or provided it to them, if the order is signed and dated by the producer;
• (b) sold or provided, for destruction, to a licensed producer who is authorized to destroy fresh or dried marihuana or cannabis oil that the producer did not produce, sell or provide, if the order is signed and dated by the producer; or
• (c) sold or provided, for destruction, to a licensed dealer who is authorized to destroy it, if the order is signed and dated by the licensed dealer.

278 The Regulations are amended by replacing “Marihuana for Medical Purposes Regulations” with “Access to Cannabis for Medical Purposes Regulations” in the following provisions:

• (a) the definitions health care practitioner and licensed producer in subsection 2(1);
• (b) subsection 8(1);
• (c) section 8.1;
• (d) paragraph 8.3(1)(a);
• (e) paragraph 9.4(2)(b);
• (f) paragraph 9.9(2)(b);
• (g) section 12;
• (h) the portion of section 46 before paragraph (a) and clauses 46(a)(ii)(B) and (C);
• (i) paragraphs 48(2)(c) and (4)(f);
• (j) subsection 53(1);
• (k) paragraphs 59(2)(c), (4)(a.1) and (f); and
• (l) subsection 73(2).

279 Item 18 of the schedule to the Regulations, as enacted by section 1 of the Regulations Amending the Narcotic Control Regulations (Tapentadol), SOR/2015-189, is renumbered as item 18.1.

New Classes of Practitioners Regulations

280 Subsections 3(2) and (3) of the New Classes of Practitioners Regulations (see footnote 2) are replaced by the following:

Fresh or dried marihuana or cannabis oil

(2) As provided for by the Access to Cannabis for Medical Purposes Regulations, a nurse practitioner, as a practitioner, may conduct an activity in respect of fresh marihuana, dried marihuana or cannabis oil in accordance with section 3 or 7 of those Regulations if

• (a) they are permitted to prescribe that substance in their practice under the laws of the province in which they are registered and entitled to practise; and
• (b) they are not named in a notice issued under section 59 of the Narcotic Control Regulations that has not been retracted under section 60 of those Regulations.
  

Definitions

(3) For the purposes of subsection (2), cannabis oil, dried marihuana and fresh marihuana have the same meaning as in subsection 1(1) of the Access to Cannabis for Medical Purposes Regulations.

Repeal

281 The Marihuana for Medical Purposes Regulations (see footnote 3) are repealed.

Application Before Publication

Application

282 For the purpose of paragraph 11(2)(a) of the Statutory Instruments Act, these Regulations apply before they are published in the Canada Gazette.

Coming into Force

August 24, 2016

283 These Regulations come into force on August 24, 2016.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the regulations.)

Executive summary

Background

Canada is a party to three United Nations (UN) conventions that regulate narcotic and psychotropic substances: the 1961 Single Convention on Narcotic Drugs, the 1971 Convention on Psychotropic Substances and the 1988 Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.

Canada has implemented the essential aspects of the UN conventions by virtue of the CDSA and its regulations. Cannabis for medical purposes is regulated under both the CDSA and the Food and Drugs Act (FDA). The CDSA and its regulations provide a framework for control of substances that can alter mental processes and that may harm an individual or society when misused or diverted to an illicit market. The purpose of the CDSA and its regulations is to protect public health and maintain public safety by balancing the need for access to these substances for medical, scientific, and industrial purposes with the need to minimize the risk of their misuse or diversion.

The FDA and its regulations provide a framework to regulate the safety, efficacy, and quality of drugs. The Food and Drug Regulations (FDR) set out a framework for the authorization of drugs for sale in Canada. Drug manufacturers submit evidence on the effectiveness, dosage, route of administration, contraindications, side effects, and quality of a drug. If Health Canada reviewers conclude that the overall benefits of the drug outweigh its risks, the product will be authorized for sale in Canada.

There are a number of products containing cannabis which have been authorized for sale under the FDR in Canada. These include

• Sativex®, a buccal spray containing extracts of cannabis with standardized concentrations of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). It is authorized to treat certain symptoms associated with multiple sclerosis. It is also conditionally authorized for pain relief in adults with advanced cancer; and
• Marinol®, a capsule containing synthetic THC. It was authorized for the treatment of AIDS-related anorexia, as well as nausea and vomiting due to cancer chemotherapy, but it was discontinued in Canada.

In these cases, the manufacturers were required to meet the requirements of the FDA and its regulations in order to sell these products in Canada.

Marihuana itself has not been authorized as a therapeutic product in Canada or in any other country. However, Canadian courts have determined that individuals who have demonstrated a medical need for marihuana, its preparations or its derivatives must have reasonable access to a legal source of these substances for medical purposes. Therefore, production of dried marihuana in the past under the MMAR was exempted from the application of the FDA and its regulations, with the exception of marihuana sold or imported to be used for the purpose of a clinical trial.

Canadians have been able to access dried marihuana for medical purposes since 1999, when the Marihuana Medical Access Program was first established. At that time, individuals were authorized to possess dried marihuana and/or produce a limited number of marihuana plants for medical purposes via the issuance of an exemption under section 56 of the CDSA. In 2001, the MMAR were established to authorize access to marihuana for medical necessity.

The MMAR evolved over time, mainly in response to a series of court decisions, and at the time of their repeal on March 31, 2014, medically authorized persons had three options for access to marihuana for medical purposes: producing it themselves (personal production), designating a producer to produce marihuana for them (designated production), or purchasing it from Health Canada. With exponential increases in program participation and in the number of plants being produced, concerns about this regime were raised by physicians, municipalities, law enforcement, and other stakeholders.

The MMPR were developed as a comprehensive response to various concerns raised by stakeholders in relation to the former MMAR, and came into force on June 7, 2013. The MMPR created the conditions for a commercial industry that produces and distributes quality-controlled dried marihuana to individuals who have the support of their health care practitioner. As of May 31, 2016, 31 licensed producers were authorized to produce and/or sell to nearly 70 000 clients.

However, as a consequence of a Federal Court injunction order issued under Allard v. Canada, nearly 28 000 former MMAR licence holders are able to continue their personal and designated production under the terms and conditions of their licences until otherwise ordered by the Federal Court.

In addition, as a result of a SCC decision issued in R. v. Smith in June 2015, individuals authorized to possess marihuana under the former MMPR and those falling under the terms of a court injunction (e.g. the Allard injunction) may now possess and alter cannabis in forms other than dried of their own choosing for their own use (e.g. cannabis oil). In order to eliminate uncertainty around a legal source of supply of cannabis, the Minister of Health issued exemptions under section 56 of the CDSA in July 2015, in part to allow licensed producers to produce and sell cannabis oil and fresh marihuana buds and leaves in addition to dried marihuana, and to allow for authorized users to possess and alter different forms of cannabis.

Finally, in February 2016, the Federal Court of Canada found the MMPR unconstitutional in that they do not provide Canadians reasonable access (i.e. affordability, availability) to marihuana for medical purposes. More specifically, the Court was of the view that the marihuana for medical purposes regime breached section 7 of the Charter by placing limits on access to marihuana for medical purposes (e.g. the elimination of personal production and the restriction to purchasing from licensed producers).

In response, Health Canada committed to introducing changes to its regulatory framework for marihuana for medical purposes to address the issue of reasonable access.

Issues

The declaration of unconstitutionality was suspended for six months from the date of the decision in Allard v. Canada — until August 24, 2016. The Government committed to responding within that timeframe by promulgating regulations that provide reasonable access to cannabis for medical purposes.

In addition, in June 2015 the SCC ruled that restricting medical access to marihuana to its dried form is inconsistent with the Charter (R. v. Smith). While the Government issued exemptions under the CDSA to respond to the Smith decision, these provisions must be incorporated into regulation to more clearly articulate regulatory requirements and simplify the regulatory framework governing cannabis for medical purposes.

Objectives

The objective of the ACMPR is to provide Canadians with a greater range of options to access cannabis for medical purposes in order to address the issue of reasonable access as identified by the court.

Description

The ACMPR provide reasonable access by enabling individuals who have the support of their health care practitioner to access cannabis for medical purposes through three access points: commercial licensed producers, personal production or designated production.

The ACMPR substantively incorporate the regulatory framework established under the former MMPR for access through the commercial industry and the former personal/designated production regime under the former MMAR.

The ACMPR also allow for the production and possession of cannabis in forms other than dried, further to the June 2015 SCC decision in R. v. Smith, by incorporating into regulation the relevant section 56 CDSA class exemptions issued in response to the decision.

The ACMPR have two parts:

• Part 1: commercial production by licensed producers responsible for the production and distribution of quality-controlled fresh or dried marihuana, cannabis oil or starting materials (i.e. seeds and plants) in secure and sanitary environments (i.e. akin to the former MMPR regime); and
• Part 2: personal and designated production regime that enables registered individuals to produce their own cannabis or designate someone to produce it for them (i.e. akin to the former MMAR regime).

It is important to note that in the ACMPR, “marihuana” means the substance referred to as “Cannabis (marihuana)” in subitem 1(2) of Schedule II to the CDSA, which includes marihuana plants and dried or fresh marihuana, whereas “cannabis” means a substance set out in item 1 of Schedule II to the CDSA that is inclusive of marihuana as well as cannabis preparations and derivatives.

General provisions

Obtaining a supply of cannabis

Health Canada maintains that the determination as to whether the use of cannabis for medical purposes is appropriate for a particular individual is best made through a discussion with an authorized health care practitioner. To obtain cannabis for medical purposes as a client of a licensed producer or as a registered person for the purpose of personal or designated production, an individual must first see an authorized health care practitioner and obtain a medical document. Authorized health care practitioners include physicians in all provinces and territories (P/Ts) and nurse practitioners in P/Ts where supporting access to marihuana for medical purposes is included under their scope of practice or in legislation. The medical document signifies the health care practitioner’s support for access to marihuana indicating, among other things, the supported daily quantity in grams of dried marihuana.

An individual or the person responsible for him/her (e.g. parents of a child) can then send an application and the original medical document to a licensed producer of his/her choice, if he/she wants to access commercially produced fresh or dried marihuana or cannabis oil, or to Health Canada if he/she chooses to produce his/her own cannabis or designate someone else to produce it. A medical document allows an individual to register with a licensed producer or with Health Canada for the period of use indicated by the authorized health care practitioner, but for no more than one year, after which a new medical document is required. The transfer of medical documents between licensed producers is not permitted.

An individual may register with Health Canada either to be a personal producer or to have a designated producer, but not for both at the same time. An individual can, however, access cannabis from licensed producers while accessing cannabis from personal or designated production. In all scenarios where more than one source of supply is desired, the individual would have to discuss this with his/her health care practitioner and would have to obtain separate medical documents — specifically one medical document for Health Canada, and one for each licensed producer. The health care practitioner may choose to divide the daily quantity as expressed in grams of dried marihuana between multiple medical documents.

The exceptions to this rule relate to obtaining (1) a supply of starting materials (marihuana seeds or plants); or (2) an interim supply of fresh or dried marihuana or cannabis oil while personal or designated production is being established. In both cases, a person registered with Health Canada can become a client of a licensed producer using his/her Health Canada registration certificate to obtain marihuana seeds and/or plants, and/or a supply of fresh or dried marihuana or cannabis oil while plants mature.

Possession of cannabis

An individual who obtains fresh or dried marihuana or cannabis oil for his/her own medical purposes from a licensed producer, or who is registered with Health Canada to access cannabis through personal or designated production, is authorized to possess at any one time a limited amount of cannabis. Similarly, an individual responsible for a person who requires cannabis for medical purposes can legally possess a limited amount of cannabis under these circumstances.

An individual is authorized to possess a total quantity of fresh or dried marihuana, cannabis oil, or products resulting from the alteration of these substances that does not exceed the equivalent of the lesser of 150 g or 30 times the daily quantity of dried marihuana (see “Dried marihuana equivalency factor”) stipulated by the authorized health care practitioner. Under the ACMPR, a client is authorized to receive the equivalent of 30 times the daily quantity of dried marihuana within each 30-day period beginning on the date of the first sale.

Under the ACMPR, a client of a licensed producer can demonstrate that he/she is in legal possession of cannabis by showing a law enforcement official a client-specific label affixed to the product’s container, or an accompanying client-specific document, as well as an appropriate piece of photo identification (see “Packaging, labelling, and shipping”). Licensed producers are required to confirm to a member of a Canadian police force, in the context of an investigation, whether a named individual is a registered client or an individual responsible for a registered client.

An individual registered with Health Canada to possess or produce cannabis and a designated producer can demonstrate that he/she is authorized to possess and conduct activities with cannabis by showing law enforcement the registration certificate issued by the Minister of Health. In the context of an investigation, a Canadian police force or a member of a Canadian police force can contact Health Canada to verify details of the registration, such as the maximum number of marihuana plants permitted, the production and storage site addresses, and the storage limit.

Health care practitioners

An individual who requires access to cannabis for medical purposes would generally obtain a medical document from an authorized health care practitioner. The medical document will contain similar information to that on a prescription. Specifically, the authorized health care practitioner will have to indicate his/her licence information, the name and date of birth of the patient, a period of use of up to one year, and a daily quantity as expressed in grams of dried marihuana.

A health care practitioner can transfer fresh or dried marihuana or cannabis oil to a person under his/her professional care or to an individual who is responsible for that person. The authority to transfer does not permit an authorized health care practitioner to provide fresh or dried marihuana or cannabis oil in exchange for something of value from an individual. In their role as health care providers and first point of contact for patients, authorized health care practitioners support access by signing the medical document with which an individual may obtain cannabis under the ACMPR. In a hospital setting, fresh or dried marihuana or cannabis oil may be administered, sold, or provided to a patient of the hospital or to an individual responsible for the patient as permitted by the person in charge of the hospital and as authorized under the Narcotic Control Regulations (NCR).

Part 1 — Commercial production by licensed producers

The majority of Part 1 incorporates the requirements of the former MMPR and relevant section 56 CDSA exemptions that responded to the decision in R. v. Smith. New provisions that did not form part of the previous framework include

• Requirements for licensed producers to notify the Minister of Health prior to commencing a recall.
• Provisions enabling individuals to receive their 30-day supply of cannabis within each 30-day period beginning on the date of the first sale. They will still be subject to the possession limit of the lesser of the equivalent of 30 times the daily quantity of dried marihuana or of 150 g.
• Labelling requirements
  • to include the percentage or the amount of THC and CBD that fresh and dried marihuana could yield, taking into the account the potential to convert THC-Acid and CBD-Acid (see footnote 4) into THC and CBD, respectively (already required for cannabis oil as part of the section 56 exemption);
  • for cannabis oil to include the carrier oil used, so that consumers have the information they need about ingredients contained in the product to make informed decisions; and
  • for cannabis oil in dosage form to include the number of capsules or units in the container, the net weight, and volume of each capsule or unit.
• The requirement for accuracy of weight and volume of products in packages to be between 95% and 105%.
• The addition of disintegration testing as part of the good production practices (GPPs) for cannabis oil in capsules or similar dosage forms.
• Requirement that all analytical testing must be done using validated methods (e.g. contaminants, disintegration, and solvent residue testing).
• Provisions enabling the tracking, production, and sale of starting materials (i.e. seeds and plants) by licensed producers.

Permitted activities and general obligations

Part 1 of the ACMPR sets out a licensing scheme that is intended to allow for the commercial production of cannabis, comparable to that for other narcotics used for medical purposes. This permits commercial production in a secure environment while regulating the quality of fresh or dried marihuana or cannabis oil, thus reducing public health, safety, and security risks. Commercial production sites by licensed producers are only to be located indoors, and not in a private dwelling.

Licensing

Either an individual or a corporation is eligible to become a licensed producer. In the application, applicants are required to describe the activities they wish to conduct with cannabis and the purpose for conducting those activities. Licensed producers can also become licensed to conduct certain activities with standardized samples of chemical substances that occur naturally in the marihuana plant in order to conduct analytical testing. For example, they will need to possess pure samples of THC and CBD in order to determine the percentage of THC and CBD in the product.

A number of conditions must be met before the issuance of a licence. The licensed producer must designate key personnel under the licence. The senior person in charge has overall responsibility for management of the activities carried out at the licensed site, while the responsible person in charge (RPIC), and alternate RPICs, if applicable, supervise all activities being carried out with cannabis. Key personnel, along with directors and officers in the case of a corporation, must hold a valid security clearance, issued by the Minister of Health (see “Security” section for further details).

The applicant for a production licence must also provide a written notification of the application to the local police force, local fire authority, and local government. The notice must specify the activities for which the licence will be sought, and the address of the site at which activities will be conducted. Another notice to these parties is required when the licence is granted, an amendment is approved, the licence is suspended or revoked for any reason, or when the licence is reinstated.

The applicant must provide information that allows Health Canada to assess whether the applicant has certain key measures in place as follows:

• a detailed description of the physical security measures that will be put in place at the site;
• a detailed description of how the licensed producer will keep records of activities with cannabis;
• a quality assurance report that shows that the buildings, equipment, and proposed sanitation program to be used meet the GPPs (see “Good production practices”) requirements;
• a copy of the notices provided to the local police force, local fire authority, and local government;
• the maximum quantity of fresh or dried marihuana or cannabis oil to be produced and sold or provided under licence (if applicable); and
• floor plans of the site.

The ACMPR also outline a number of reasons for which the Minister of Health is required to refuse to issue, renew, or amend a licence. These include the following:

• reasonable grounds to believe that false or misleading information has been provided with the application;
• information received from a peace officer or other authority that gives the Minister reasonable grounds to believe that the applicant has been involved in the diversion of a controlled substance;
• the issuance or continuation of the licence will likely create a risk to public health, safety, or security, including diversion; and
• key personnel do not hold a valid security clearance.

Once issued, a licence is valid for up to three years and can be renewed. The ACMPR also set out a process for amendments to any information on the licence (e.g. the licensed producer wishes to increase its production yield or change sites).

Licensed producers are also subject to regular, unannounced compliance and enforcement inspections. Inspections can also occur when there is reason to believe the Regulations are being contravened.

Good production practices

The FDA applies to cannabis produced under the ACMPR and prohibits the sale of cannabis that had been produced under unsanitary conditions or that has been adulterated.

Licensed producers are also subject to the GPPs outlined in the ACMPR. The GPPs require cleanliness of the premises and equipment. The licensed producer is also required to employ a quality assurance person with appropriate training, experience, and technical knowledge to approve the quality of fresh and dried marihuana, cannabis oil, and marihuana seeds and plants prior to making them available for sale. Finally, licensed producers have to test their fresh and dried marihuana and cannabis oil for microbial and chemical contaminants and ensure they are below generally accepted tolerance limits for human consumption, as established in any publication referred to in Schedule B to the FDA (i.e. various pharmacopoeia and formularies). Validated testing methods must be used. Cannabis oil must not contain residues of solvents other than those specified, and under acceptable limits. In addition, licensed producers must conduct disintegration testing on capsules or similar dosage forms to ensure that these products will disintegrate appropriately when ingested.

In the event that a licensed producer undertakes a recall, the licensed producer must notify Health Canada prior to commencing a recall.

Dried marihuana equivalency factor

Licensed producers are required to determine the quantity of fresh marihuana or cannabis oil that is equivalent to 1 g of dried marihuana and make this information available on the product label, their Web site, or upon request. For substances obtained from a licensed producer and products resulting from the alteration of these substances, individuals must calculate their possession limit by taking into account the dried marihuana equivalency factor, and in the case of products resulting from alterations, by also taking into account the weight of fresh or dried marihuana — or the volume of any cannabis oil — that was used to make them.

Packaging, labelling, and shipping

Fresh or dried marihuana or cannabis oil must be packaged in a tamper-evident and child-resistant container. The maximum package size for fresh or dried marihuana or cannabis oil will be 30 g of dried marihuana or its equivalent. Each package will contain standard information about the product, including the weight in grams, the percentage by weight of THC and of CBD for all fresh and dried marihuana, the percentage of THC and CBD that the product could yield (i.e. including amounts of THC + THC-Acid, and CBD + CBD-Acid), the packaging date, the expiry date if one has been established by stability testing, and a warning statement to “KEEP OUT OF REACH OF CHILDREN.”

For cannabis oil, additional labelling requirements include the carrier oil used, the amount of THC and CBD in milligrams per millilitre (mg/ml) or in milligrams per capsule, potential food allergens in the product, the equivalency factor, and a warning not to ingest oil if for topical use. If the product is in a capsule or similar dosage form, the number of capsules, the net weight, and the volume in each capsule or unit must also be provided, and the quantity of THC cannot exceed a maximum yield of 10 mg per capsule or unit, taking into account the potential to convert THC-Acid into THC.

The licensed producer must also affix a client-specific label, similar to a patient-specific prescription drug label, to the package. For fresh or dried marihuana or cannabis oil, this label must contain the name of the client and the name of the authorized health care practitioner who provided the medical document, the daily quantity of dried marihuana, and the end of the validity period as indicated on the medical document. The label must also include the shipping date and the anticipated date of delivery to the registered client. The licensed producer must produce a separate duplicate document of this label to send to the client. This duplicate document or the product label, as well as an appropriate piece of photo identification, can serve to demonstrate legal possession (see “Possession of cannabis”).

Each package of fresh or dried marihuana, marihuana seeds or plants, or cannabis oil sold to a client must also be accompanied by a copy of the most recent version of the Health Canada document entitled Consumer Information — Cannabis (Marihuana, marijuana). This document indicates that the safety and efficacy of cannabis for medical purposes has not been established and provides a summary of the known information about the uses and risks of cannabis for medical purposes so that individuals can be informed about their treatment choice.

When selling seeds and plants, licensed producers must ensure that they are sold in a container or a package, respectively, that is tamper resistant. Containers for seeds must also keep the seeds dry and free from contamination. Client labels for the immediate container of seeds and on each plant or package of plants must contain the name of the licensed producer, the name of the client, the expiry date of the client’s registration, and the shipping date.

The FDA provisions also apply in order to prohibit labelling, packaging, or selling in a manner that is false, misleading, or likely to create an erroneous impression about the character or safety of the drug. For example, unsubstantiated health claims cannot be put on product packaging. Advertising any narcotic to the general public is prohibited under the NCR, and this prohibition continues to apply to cannabis. As with other narcotics, this is intended to prevent known and potential harms to the health of Canadians who are vulnerable with respect to the advertising of prescription drugs. To help individuals identify a licensed producer, Health Canada publishes the names and contact information of licensed producers on its Web site.

Import and export

Licensed producers are permitted to engage in the import or export of seeds, plants, or dried marihuana if they have obtained an import or export permit from Health Canada. The import/export permit framework is similar to that for other controlled substances and is intended to maintain control over the movement of controlled substances, consistent with Canada’s obligations under international conventions on the control of narcotic drugs and psychotropic substances.

Security

Health Canada’s Directive on Physical Security Requirements for Controlled Substances establishes security requirements for the storage of all controlled substances, including cannabis. These requirements are scaled to the illicit market value of the controlled substance and to the crime rates in various areas.

The ACMPR set out physical security requirements for the entire site, as well as for areas within a site where cannabis is present. These include all areas where a licensed activity is conducted with cannabis (i.e. a lab, the production room, the area where cannabis is packaged and labelled). Access to these areas is restricted only to individuals whose presence is required because of their work responsibilities. Licensed producers must put systems in place to ensure that access is controlled at all times, as well as 24/7 visual monitoring systems to detect unlawful conduct. The restricted areas must also be secured by an intrusion detection system that will detect attempted or actual unauthorized access to the area.

The same principles of visual monitoring and intrusion detection apply to the perimeter of the entire site. Licensed producers must also ensure the site and its restricted areas include physical security barriers designed to prevent unauthorized entry. Personnel monitoring the security and surveillance systems of a licensed site must take action in response to a detected incident and record the details of the action(s) taken. Should an applicant for a licence fail to demonstrate that appropriate physical security measures as outlined in the ACMPR are in place, the production licence could be refused.

The ACMPR also include requirements that the holder of the production licence, directors and officers (in the case of a corporation), and all key personnel must hold enhanced security clearances prior to the issuance of a producer’s licence. To obtain an enhanced security clearance, these individuals are required to submit an application with personal information and documents to Health Canada, so that checks and verifications of relevant files of law enforcement agencies can be conducted. As well as criminal record checks, these clearances involve a global evaluation of the applicant’s potential associations with criminal or violent organizations, associations with individuals linked to such organizations, and the risk of whether the applicant might be induced to assist, abet, or commit any act that will pose a risk to the control of the production and distribution of cannabis. Should the applicant not successfully obtain a security clearance, the production licence could be refused.

Information sharing

The ACMPR include provisions that require licensed producers to share information with appropriate authorities in certain circumstances. For example, law enforcement needs a way to verify whether a named individual is a registered client of the producer. If a member of a Canadian police force requires information in the course of an investigation, a licensed producer is required to confirm as soon as feasible, within 72 hours after receiving the request, whether the individual is a registered client or an individual who is responsible for a registered client and the daily quantity of dried marihuana specified in the medical document or the individual’s registration with the Minister of Health under Part 2 of the ACMPR.

Licensed producers are required to provide P/T health care licensing authorities with factual information about a health care practitioner — notably patient information —from the medical document when requested by a licensing authority to support a professional investigation.

Consistent with the objective of providing information to health care licensing authorities to allow them to more effectively monitor the practices of their members, licensed producers must, when requested by the relevant health care licensing authority, provide the health care practitioner information (name, address, and professional licence number), daily quantity of dried marihuana indicated on the medical document, period of use, date the medical document was signed by the practitioner, and basic patient information to the health care licensing authority. Licensed producers must communicate this information to the relevant health care licensing authority in writing on a quarterly basis.

New information-sharing provisions have also been created to require licensed producers to notify Health Canada if they refuse to register an applicant whose application is supported by the Minister of Health under Part 2.

Distribution through licensed producers

The primary means of distribution of dried and fresh marihuana, cannabis oil, and marihuana seeds and plants is directly from the licensed producer to the registered client using secure shipping methods, as the ACMPR do not allow for storefront or retail distribution centres.

Before selling to an individual, a licensed producer must register the individual as a client. In the process of registering a client on the basis of a medical document, a licensed producer must verify that the supporting health care practitioner is authorized to practice the profession in the province in which he/she was consulted by the prospective client and that he/she has not been prohibited from prescribing narcotics. A licensed producer must ensure that the applicant has consulted with the health care practitioner and that the information in the medical document is correct and complete by confirming this with the health care practitioner’s office in the event that the signature of the health care practitioner is not known.

A licensed producer can also register a client using a registration certificate issued by Health Canada in place of a medical document in order to provide starting materials (i.e. marihuana seeds and plants) and/or an interim supply of dried or fresh marihuana or cannabis oil before the registered or designated production yields a harvestable crop.

Dried and fresh marihuana, cannabis oil, and marihuana seeds and plants must be shipped directly to a registered client at a shipping address authorized in the Regulations, using a shipping service that includes a means of tracking the package during transit. Shipments must be securely packed and shipped in a package that will not allow the contents to be identified visually or by odour.

Record keeping

Licensed producers must keep records of their activities with cannabis, including all transactions (sale, exportation, and importation), all products returned from clients, and an inventory of cannabis (e.g. seeds, fresh harvested marihuana, dried marihuana, cannabis oil, marihuana plants, and packaged marihuana). All records must be kept for a period of at least two years, in a format that is easily auditable and available to Health Canada upon request.

Part 2 — Production for Own Medical Purposes and Production by a Designated Person

Part 2 of the ACMPR sets out a registration framework that allows for personal-use and designated production of cannabis (including cultivation of plants and alteration of products) for medical purposes.

Note: The majority of Part 2 incorporates the requirements of the former MMAR and relevant section 56 CDSA exemptions that respond to the decision in R. v. Smith with required modifications to incorporate the production, storage and possession of products other than dried marihuana or plants. New provisions that did not form part of the previous framework include the following:

• Proof of possession and registration can be demonstrated through a registration certificate issued by Health Canada.
• Starting materials (i.e. seeds and plants) can be obtained through licensed producers.
• Interim supply of cannabis (until plants are ready) can be obtained through licensed producers.
• Security measures do not need to be listed on the registration application, but those registering to possess and produce cannabis must declare that security measures are in place to keep plants and products secure.
• Information sharing provisions have been expanded to enable proactive sharing of information on registered persons with P/T health care licensing authorities.

Registration with Minister

To be eligible to apply to Health Canada under Part 2 of the ACMPR to produce cannabis for medical purposes, or designate someone to produce it on his/her behalf, an individual with a medical document must ordinarily reside in Canada. A personal or designated producer must be an adult. Additionally, the eligibility criteria include that an applicant for a registration as a personal producer must not have been convicted in the preceding 10 years of a designated marihuana offence that was committed while he/she was authorized to produce marihuana under the CDSA other than under the ACMPR or a designated cannabis offence that was committed while authorized under the ACMPR to produce cannabis. If the preference is to designate another individual to produce cannabis, this person must be indicated in the application, and must meet a separate set of eligibility criteria, including that he/she has not been convicted, as an adult, of a designated drug offence in the preceding 10 years. Although minors are not able to register for personal production under these Regulations, a person who is responsible for the minor (e.g. parent) can apply for a registration on behalf of the minor and can request to be the designated person for the production of cannabis.

The individual seeking registration to produce cannabis for his/her own medical purposes, or the individual who is responsible for him/her, must submit a medical document and an application containing information such as

• personal information, such as name and date of birth;
• residential address, production, and storage site addresses;
• whether the cultivation of marihuana will take place indoors and/or outdoors;
• property owner consent for the production site (if required);
• a declaration that he/she will take all necessary measures to ensure the security of the cannabis and that the proposed site is not adjacent to a school, public playground, daycare, or other public place frequented mainly by persons under 18 years of age if the proposed production area involves outdoor production; and
• a declaration by the designated producer (if applicable).

Grounds for refusal

The Minister must refuse to register an applicant (either for personal or designated production) based on a number of grounds, including

• ineligibility;
• false or misleading information in the application to register;
• a medical document that is no longer valid;
• if a producer would be authorized to produce marihuana plants under more than two registrations; or
• the proposed site for the production of marihuana plants would be a production site under more than four registrations.

If the Minister proposes to refuse to register an applicant, the applicant will be notified in writing of the reason for the proposed refusal and will be provided with an opportunity to be heard.

Successful registration

Following a review of the application, if the requirements are met successfully and there are no applicable grounds for refusal, the Minister must register the applicant.

The registered person will receive a registration certificate, and, if applicable, a document containing information relating to the production will be sent to the designated person. The registration certificate provides the individual with the necessary information to understand the authorized activities. Furthermore, this certificate can serve as the means of establishing the individual’s lawful proof of possession/production if required by law enforcement.

Registrations are valid for a period of up to a year, based on the period of use specified by the health care practitioner on the medical document.

Renewals

A registered person can apply to renew his/her registration with Health Canada prior to the expiry date of the registration.

Registration amendments

A registered person can amend his/her registration. These amendments may relate to any information set out in the registration, including the name of the registered or designated person, the address of the production site, and the designated producer (i.e. replacing the designated producer with a new person). The application must include the registration number, a description of the proposed amendment, the supporting reason for it, the information and documents required in a registration application that are relevant to it, and the date that it is to take effect. In the case of a change in the name of the registered person, the designated person, or an individual responsible for the registered person, proof of the change must also be submitted.

In the case of a new medical document (e.g. change in daily amount supported by the health care practitioner), a new registration application must be submitted.

Authorized activities

As a registered person, an individual is authorized to possess and alter cannabis for his/her own medical purposes. He/she must comply with the requirements of the ACMPR and with the registration, including with the possession limits established based on the equivalent of the lesser of the 30-day supply (derived from the daily quantity supported by the health care practitioner) or 150 g, as expressed in grams of dried marihuana. A registered person whose registration specifies a designated person may also, if an adult, participate in the activities that the designated person is authorized to conduct under the registration.

A registered person who produces for his/her own medical use may produce, transport, and store cannabis in accordance with the requirements of Part 2 of the ACMPR and with the registration.

A designated producer may produce cannabis for the medical purposes of the registered person, store, transport, ship, provide, or deliver cannabis in accordance with the requirements of Part 2 of the ACMPR and with the registration. The shipping, provision, or delivery may only be to the registered person (i.e. the medically authorized person) or the person responsible for the registered person.

Dried marihuana equivalency

The daily quantity of dried marihuana authorized, and maximum possession and storage amounts, are articulated in terms of grams of dried marihuana. Registered and designated persons are required to manage their limits based on the quantity of fresh marihuana, cannabis oil, or other products that are equivalent to a given quantity of dried marihuana calculated in accordance with the regulations.

For these purposes, 5 g of fresh marihuana is determined to be equivalent to 1 g of dried marihuana. The quantity of products that is equivalent to a given quantity of dried marihuana is calculated by taking into account the weight of fresh or dried marihuana that was used to make the products.

Maximum production and storage amounts

The Regulations establish formulas for converting the supported daily quantity of dried marihuana into a maximum number of plants and maximum quantity of dried marihuana in storage. The formulas apply to both personal and designated production, and cover indoor, outdoor, and partial indoor / partial outdoor production.

The formulas convert the daily quantity supported by the health care practitioner into a maximum number of plants. The formulas take into account differences in indoor and outdoor growing conditions, and apply standard values for the following elements:

• Plant yields: 30 g indoors and 250 g outdoors.
• Growing cycles: Three indoors and one outdoors.
• Crop loss: 20% loss allowance indoors and 30% outdoors.

Under indoor growing, every 1 g per day of dried marihuana that is medically authorized results in the production of five plants. Under outdoor growing, every 1 g per day of dried marihuana that is medically authorized results in the production of two plants. If the production of marihuana plants is partly indoors and partly outdoors, every 1 g per day of dried marihuana results in four plants indoors and one plant outdoors.

Personal and designated producers are required to securely store cannabis indoors at the site authorized in the registration, per storage limits indicated in the registration. Storage limits are based on the plant limit and anticipated yield of dried marihuana produced per plant (i.e. 30 g for plants grown indoors and 250 g for plants grown outdoors). Like the formulas for plant limits, the formulas for storage limits were originally developed and consulted on in 2001 (i.e. were part of the former MMAR). The storage formulas allow producers to maintain reasonable amounts of inventory while growing and/or drying newly harvested material. Applying the formula applicable to indoor production, for example, a producer growing 10 plants would be allowed to store the equivalent of a maximum of 450 g of dried marihuana.

Maximum number of registrations

An individual can produce under two registrations (i.e. for two others as a designated person or one other person as a designated producer and him/herself as a personal producer).

In addition, a maximum of four registrations is permitted per production site.

Cancellation of registration

The registered person may request that Health Canada cancel the registration. Persons responsible for the registered person may also submit a cancellation request on his/her behalf. Registration may also be cancelled by Health Canada for reasons such as

• ineligibility of the registered person or designated producer;
• the registration was issued on the basis of false or misleading information;
• the registration is to produce at a site where there is already production under four registrations;
• the health care practitioner no longer supports the individual’s use of dried marihuana for clinical reasons; or
• the registered person dies or ceases to be ordinarily resident in Canada.

Upon cancellation of the registration, the production of cannabis under the registration ceases to be authorized. The Minister of Health must give the registered person written notice of the reasons for the proposed cancellation and an opportunity for the registered person to be heard.

Obtaining starting materials

A person who is registered to produce cannabis or have a designated person produce it for him/her will need access to starting materials (i.e. seeds or plants). After registering with Health Canada, an individual can obtain starting materials from a licensed producer. Licensed producers are permitted to register clients using a Health Canada registration certificate in place of a medical document in order to provide starting materials. These starting materials may be either seeds or plants, shipped in compliance with the packaging, and relevant labelling and shipping requirements outlined in Part 1 of the ACMPR. Only a registered person is permitted to become a client of a licensed producer in this manner; a designated producer is not permitted to register for starting materials. This allows the registered person to have an active role in choosing the strain(s) of marihuana to use for medical purposes.

A registered person can purchase seeds or plants from a licensed producer up to a maximum quantity that, taking into account the fact that three marihuana seeds are equivalent to one plant, does not exceed the equivalent of the maximum number of marihuana plants authorized. It is expected that starting materials would be required at the outset of a person’s registration; however, there is not a limit to the number of times a person can purchase starting materials to account for the potential of crop failure.

Interim supply

Until such time when usable product is available (i.e. when plants are ready for harvest) or in the absence of sufficient harvest (e.g. due to crop failure), a registered person has the option of seeking an interim supply from a licensed producer.

Licensed producers are permitted to register clients using the registration certificate issued by Health Canada in place of a medical document to accommodate registered persons obtaining an interim supply of fresh or dried marihuana or cannabis oil until their own supply is ready.

Communication of information

The ACMPR include provisions that require or allow Health Canada to share information with appropriate authorities in certain circumstances. Information sharing relates to police, P/T health care licensing bodies and licensed producers.

Police: Consistent with the information sharing provisions in place under the former MMAR, and in line with those for licensed producers under the former MMPR, Health Canada will share limited information with police. This includes information such as whether an individual is a registered or designated person, the address of the production site, the plant limit, the possession limit, and the storage limit. This communication of information will be restricted to the context of an active investigation under the CDSA or the ACMPR.

Licensing Authorities: Consistent with Part 1 requirements for licensed producers, Health Canada is required to provide P/T health care licensing authorities with factual information about a health care practitioner that has been obtained under the CDSA, the NCR, the ACMPR, the former MMPR, or the former MMAR, when requested by a licensing authority to support a professional investigation (as per the NCR). Information sharing provisions have also been expanded from the former MMAR to enable Health Canada to proactively share information on registered persons with P/T health care licensing authorities.

Licensed Producers: Health Canada is also authorized to communicate with licensed producers in the event that a registration with the Minister under Part 2 is cancelled. If Health Canada is aware that a registration certificate has been submitted to a licensed producer, and is subsequently cancelled, Health Canada must notify the licensed producer of the cancellation and provide limited, relevant information.

Transitional provisions

Transitional provisions allow licensed producers to continue to operate with licences and permits issued under the former MMPR until they expire or are revoked. This includes supplementary licences that permit the production and sale of cannabis oil or fresh marihuana, as well as import or export permits. Transitional provisions also provide that licence and permit applications submitted under the former MMPR and in respect of which the Minister has not made a decision to approve or refuse the application before the coming into force of the ACMPR will be processed under the ACMPR. Security clearances granted under the MMPR remain valid until they expire or are cancelled.

Transitional provisions also provide for the continued validity of client registrations by licensed producers under the former MMPR, until they expire or are cancelled.

Transitional provisions also enable licensed producers, who were authorized to sell or provide dried marihuana under the former MMPR, to sell or provide seeds and plants to a client registered on the basis of a registration with the Minister under Part 2 until the earlier of six months following the coming into force of the regulations or the expiry, suspension, or revocation of the producer’s licence, after which time the sale or provision of seeds and plants will have to be authorized by the producer’s licence. Licensed producers also have six months to comply with the packaging and labelling requirements of the ACMPR.

Consequential amendments

The FDA and its regulations provide a framework to regulate the safety, efficacy, and quality of drugs. Cannabis for medical purposes meets the definition of a “drug” under the FDA. The sale of a drug in Canada must comply with the FDA and its regulations.

The Cannabis Exemption (Food and Drugs Act) Regulations, which replace the Marihuana Exemption (Food and Drugs Act) Regulations, exempt cannabis produced by licensed producers or designated persons, or marihuana that is imported or exported by licensed producers in accordance with the ACMPR, from application of the FDR. For example, cannabis that is produced and sold by a licensed producer or by a designated producer in accordance with the ACMPR does not have to undergo the market authorization process in Canada before it is produced and sold in Canada.

Cannabis that is sold or marihuana that is imported, including by a licensed producer, to be used in clinical trials will continue to be subject to the FDR.

The FDA continues to apply to all cannabis produced, sold, imported, or exported under the ACMPR (e.g. the FDA require that cannabis be produced in sanitary conditions, and provides the Minister of Health with the power to order a recall).

Consequential amendments have also been made to the NCR and the New Classes of Practitioners Regulations (e.g. definitions for new items — “fresh marihuana,” “cannabis oil,” “former MMPR” and “former MMAR” — have been added, and product scope expanded beyond dried marihuana to include fresh marihuana and cannabis oil where applicable).

The MMPR are repealed on the coming into force of the ACMPR.

Regulatory and non-regulatory options considered

Non-regulatory options were not considered feasible. Not responding with new regulations within the timeline mandated by the court would leave individuals with a need for cannabis for medical purposes without lawful access. Further, there would be no legal framework to authorize the commercial production and sale of quality-controlled cannabis for medical purposes, creating health, safety, and security risks to those who would be forced to purchase cannabis from unregulated sources.

Given the nature of the court ruling, and the compressed timeline, the only feasible way to address the issue of reasonable access is through the reintroduction of personal and designated production per the former regime under the MMAR, in addition to preserving the current commercial regime.

It should be noted that consideration was given to enabling pharmacy distribution of cannabis. However, the pharmacy distribution approach on its own would not address the issue of reasonable access to cannabis for medical purposes. The standard mark-up applied to prescription medication may be applied, as well as the additional dispensing fees, potentially resulting in higher costs compared to personal and designated production. Further, even if enabled at the federal level, it would likely require regulatory changes in all provinces and territories in order for countrywide access to be implemented. The timeline imposed did not permit such an approach; however, this option could be considered in the future.

Benefits and costs

Baseline scenario

The system of licensed producers who are authorized to produce and sell fresh and dried marihuana and cannabis oil to clients who have registered with the support of a health care practitioner was established by virtue of the former MMPR. The vast majority of the regulatory requirements relating to commercial production and distribution by licensed producers remain the same under the ACMPR. Licensed producers are subject to various administrative and compliance costs in order to ensure the quality of cannabis sold and to reduce risks of diversion, but they also benefit from the opportunity to participate in the business of providing cannabis for medical purposes directly to eligible consumers. They are free to compete within the bounds of the Regulations and grow their client base. A full cost benefit analysis was prepared at the time the MMPR were introduced. Health Canada costs to administer the MMPR in 2015–2016 were approximately $9.9 million.

In addition to licensed producers, an estimated 28 000 individuals are permitted to possess and produce marihuana (dried marihuana and plants) under the terms and conditions of the former MMAR by virtue of an injunction issued by the Federal Court of Canada in Allard v. Canada. This injunction remains in effect until the Federal Court of Canada orders otherwise. The only ongoing administrative cost associated with this group is incurred by Health Canada and factored into the costs described above. That is, Health Canada operates a general information call centre and a police line, which allows the police to inquire about authorizations and licenses issued under the former MMAR, which may still be valid under the injunction.

Costs and benefits described herein are incremental to the baseline described above. There are three primary groups who will be impacted by the introduction of the ACMPR: Canadians who need cannabis for medical purposes, licensed producers, and Health Canada.

Canadians who need cannabis for medical purposes

It is anticipated that this regulatory regime will provide a benefit to Canadians who need cannabis for medical purposes by reintroducing two additional means of access: personal and designated production. This will permit Canadians to decide which form of access best accommodates their personal situation, whether by cost or convenience.

While establishing a personal or designated source of cannabis would involve some start-up costs (e.g. registration with Health Canada and purchase of starting materials), this sourcing will be an option offered to Canadians.

Those who have continued personal and designated production under the terms of a court injunction would have the opportunity to obtain a medical document from a supporting health care practitioner and register under the ACMPR. This is no different than someone seeking to access cannabis for the first time or a client of a licensed producer wishing to switch sources. There are no incremental impacts on this group.

The introduction of this regulatory regime will provide a benefit to those who have continued personal and designated production under the terms of a court injunction, as it will allow them to produce at a new location. Notably, this will allow these individuals to register with the Minister of Health under Part 2 of the ACMPR to produce cannabis at a new site, as changes to any MMAR licences are not permitted given the repeal of the MMAR.

It should also be noted that there are no incremental impacts on those who accessed cannabis from licensed producers under the former MMPR and who continue to do so under the ACMPR.

Licensed producers

Incremental costs include minor administrative changes as well as changes to the labelling requirements, which build on practices and processes or equipment that licensed producers already have or use and are not expected to result in significant costs. In addition, incremental costs are expected to be offset by new revenue potential provided through the ACMPR.

The packaging and labelling requirements are anticipated to require the most involved change; however, based on observations of licensed producer packaging and labelling practices, it is not anticipated to have significant cost impacts, and licensed producers will have six months to comply with these requirements. If licensed producers also choose to produce cannabis oil in capsules or similar dosage forms intended for ingestion, they will have to conduct disintegration testing. This will also result in a minor incremental cost.

Under the ACMPR, licensed producers will be able to sell seeds and plants (i.e. starting materials). Although there are administrative requirements associated with recordkeeping and reporting, similar to those of the other products sold under the ACMPR, licensed producers will also generate profit from the expanded scope of sales permitted.

Licensed producers will not be compelled to participate in these business lines (e.g. sale of starting materials), so it will be a business decision for each licensed producer as to whether to incur the initial costs to establish these product lines.

The ACMPR are also anticipated to have incremental benefits for licensed producers, including a streamlined approach to licensing by allowing for a single application to address the production and sale of fresh and dried marihuana, cannabis oil, and marihuana seeds and plants (i.e. eliminating the need for a supplemental application for cannabis oil and fresh marihuana). In addition, licensed producers will no longer be required to verify medical documents (i.e. make phone calls to all health care practitioner offices), where the signature of the health care practitioner is known to the producer.

Licensed producers have expressed little concern with the financial impact associated with the reintroduction of personal and designated production. Since the introduction of the MMPR, the market for marihuana for medical purposes has included a segment that is sourced by personal production (i.e. Allard injunction holders). Therefore, allowing for more personal and designated production is not anticipated to have a significant impact on the market, including those licensed producers which are small businesses. Given that it is not known when the injunction will be lifted or how many Canadians will be interested in registering under the ACMPR or the timing for their registration, it is not possible to quantify this impact at this time.

Health Canada

As the number of participants under the former MMAR grew, Health Canada’s administrative costs increased to almost $25 million annually (including salary, operating and management expenses, and supply contract) by the time the MMAR were repealed. It is expected that the Health Canada administrative costs for the ACMPR will be significantly less. The rate at which the number of participants in the personal and designated production program increases is expected be slower than the rate under the former MMAR since individuals will also be able to access cannabis through licensed producers. In addition, Health Canada will not supply cannabis or starting materials.

Costs of approximately $1.5 million (see footnote 5) in the first fiscal year (2016–2017) are expected, in order to address administrative start-up costs and operating costs, assuming 20 000 Canadians seek to register in the first year. It is expected that uptake will be gradual, considering the need for a medical document for registration and the possible continued existence of the injunction.

An annualized average cost of approximately $3.4 million PV is expected. Costs will be driven by registration uptake, and have been estimated based on the entry of approximately 20 000 individuals in the first fiscal year, the entry of injunction holders in early 2017–2018 (pending lifting of injunction), and a 9% growth rate thereafter, consistent with what has been seen with the licensed producer client registrations. Costs are dependent on, and may vary according to, the volume of applications received. With the unpredictable nature of a reactive program and significant change in the realm of cannabis over the coming years, specifically marihuana legalization, it is difficult to predict volume trends, especially in the longer term.

Ongoing administrative costs will include functions such as processing registration applications, annual renewals, and amendments; conducting verifications and providing information to licensed producers; preparation of data for health care licensing bodies; responding to police requests; and operating a client-service program, including a call centre and correspondence services.

Cost-benefit statement

	Base Year (2016)	Final Year (2026)	Total (PV)	Annualized Average
A. Quantified impacts (in CAN$, 2016 price level / constant dollars) (see note *)
Costs for Health Canada	$1,495,327	$1,880,892	$24,024,635	$3,420,567
B. Qualitative impacts
Individuals who need cannabis for medical purposes (positive): Reintroduction of two additional means to access cannabis (personal and designated production). Those who have continued personal and designated production under the terms of the Allard injunction are allowed to apply to register to produce at a new location. No fees are charged in registering with Health Canada.
Individuals who need cannabis for medical purposes (negative): Start-up costs to begin personal or designated production (registration with Health Canada and purchase of starting materials).
Licensed producers (positive): New ability to sell seeds and plants to individuals for personal or designated production (starting materials). A single application to address the production and sale of fresh and dried marihuana, cannabis oil, and marihuana seeds and plants (i.e. eliminating the need for a supplemental application for cannabis oil and fresh marihuana). Reduced administrative costs as a result of a streamlined approach to the verification of medical documents that is now harmonized with requirements that apply to prescriptions for narcotics.
Licensed producers (negative): Minor administrative changes as well as changes to the labelling and packaging requirements. Some minor potential loss of client base for those who wish to produce their own marihuana.
Health Canada (positive): Administrative costs for the ACMPR will be significantly less than those under the former MMAR given that the rate of increase for personal and designated production is expected to be slower than the rate under the former MMAR. This is because individuals will also be able to access cannabis through licensed producers. Further, Health Canada will not supply cannabis.

• Note *
  Costs have been discounted using a 7% discount rate to estimate present value beginning in 2016.

“One-for-One” Rule

The “One-for-One” Rule applies to the ACMPR; however, they are exempted from its application because they are implementing non-discretionary obligations flowing from the Federal Court of Canada’s decision in Allard v. Canada. The Federal Court of Canada found the MMPR unconstitutional, and the Government was given six months from the date of the decision — until August 24, 2016 — to implement new regulations that provide reasonable access to cannabis for medical purposes.

The “One-for-One” Rule does not apply to the Cannabis Exemption (Food and Drugs Act) Regulations, as the amendments to these Regulations do not result in any change in administrative burden on business.

Small business lens

The incremental costs are estimated to be less than $1 million on small business; therefore, the small business lens does not apply to this proposal.

Consultation

Given the compressed timeline and the potential consequences of not implementing regulations by August 24, 2016, opportunities for formal consultation were limited.

The ACMPR substantively incorporate the provisions established under the former MMPR for the commercial industry and the personal and designated production framework as per the former MMAR. Stakeholders had the chance to provide feedback on these frameworks when they were published previously, including through the two-year consultation process that led to the publication of the MMPR in 2013. Deviations from these frameworks are minimal, except where required to respond to decisions from the courts.

Prior to implementation, Health Canada conducted targeted engagement with other government departments and agencies (Public Safety Canada, Justice Canada, Royal Canadian Mounted Police, Veterans Affairs Canada, and Global Affairs Canada). The government departments and agencies emphasized the need for ongoing collaboration to implement the ACMPR. Licensed producers were also engaged regarding certain policy aspects of personal and designated production, and how the commercial industry could operate alongside a personal and designated production regime.

Rationale

The Federal Court of Canada’s finding of unconstitutionality of the MMPR related to the problems of affordability and availability, which are aspects of reasonable access.

Given the nature of the court ruling, and the compressed timeline, the only feasible way to address the issue of reasonable access is through the reintroduction of personal and designated production, in addition to preserving the current commercial production and distribution regime (which serves to reduce risks to public health, security, and safety of Canadians, while providing access to quality-controlled cannabis for medical purposes).

The ACMPR provide reasonable access by enabling individuals who have the support of their health care practitioner to access cannabis for medical purposes through three access points: commercial licensed producers, personal production, or designated production.

Retaining the elements of the former MMPR allows for the continuation of the current industry, which provides for uninterrupted production and supply for the approximately 70 000 individuals sourced by licensed producers.

The ACMPR also incorporate provisions to allow for the production and possession of cannabis in forms other than dried, further to the June 2015 SCC decision in R. v. Smith.

Implementation, enforcement and service standards

The MMPR are repealed and the ACMPR come into force on August 24, 2016. It is Health Canada’s intention that the transition between these regulatory regimes be seamless.

Licensed producer applications submitted under the former MMPR will retain their place in the review process and will be processed under the ACMPR. Further, applicants for production licences will be offered the opportunity to update their applications to add new activities with substances other than dried marihuana. Licensing and inspections of commercial producers will continue as under the former MMPR. Limited modifications to processes and procedures will be necessary.

Health Canada will allow for the receipt of registration applications for personal and designated production from the date on which the ACMPR come into force. Service standards for the processing of these applications will be established as the regime becomes operational.

Infrastructure and human resource requirements to operationalize the ACMPR regime were put in place over the summer of 2016 in order to enable immediate implementation. For example, Health Canada has implemented an IT system for managing applications and generating registration certificates. Health Canada has also established a program unit dedicated to administering the personal and designated production elements of the ACMPR. In addition, application forms and operational guidance are available for clients and licensed producers on the Health Canada Web site.

Contact

Office of Medical Cannabis
Health Canada
Ottawa, Ontario
Address Locator: 0302B
K1A 0K9
Email: OMC-Engagement-BCM@hc-sc.gc.ca

• Footnote a
  S.C. 1996. c. 19
• Footnote b
  S.C. 2015, c. 22, s. 4(1)
• Footnote c
  S.C. 1996. c. 19
• Footnote 1
  C.R.C., c. 1041
• Footnote 2
  SOR/2012-230
• Footnote 3
  SOR/2013-119
• Footnote 4
  Note: THC-Acid is a non-psychoactive cannabinoid found in raw and live cannabis. When exposed to processes such as drying and heating, THC-Acid changes to psychoactive THC. Under these conditions, CBD-Acid is also converted to CBD.
• Footnote 5
  Note: Costs include salary, operating and management expenses, employee benefit plan costs, accommodation costs, and corporate (internal services) costs, and are present value costs as of 2016–2017.