Canada Gazette, Part I, Volume 146, Number 50: Marihuana Exemption (Food and Drugs Act) Regulations

December 15, 2012

Statutory authority

Food and Drugs Act

Sponsoring department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

For the Regulatory Impact Analysis Statement, see Marihuana for Medical Purposes Regulations.

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to paragraph 30(1)(j) of the Food and Drugs Act (see footnote a), proposes to make the annexed Marihuana Exemption (Food and Drugs Act) Regulations.

Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part Ⅰ, and the date of publication of this notice, and be addressed to the Bureau of Medical Marihuana Regulatory Reform, Controlled Substances and Tobacco Directorate, Healthy Environments and Consumer Safety Branch, Health Canada, Address Locator: AL3503D, Ottawa, Ontario K1A 0K9 (fax: 613-941-7240; email: consultations-marihuana@hc-sc.gc.ca).

Ottawa, December 6, 2012

JURICA ČAPKUN
Assistant Clerk of the Privy Council

MARIHUANA EXEMPTION (FOOD AND DRUGS ACT) REGULATIONS

DEFINITIONS

Definitions

1. The following definitions apply in these Regulations.

  • “licensed producer”
    « producteur autorisé »
  • “licensed producer” has the same meaning as in subsection 1(1) of the Marihuana for Medical Purposes Regulations.
  • “marihuana”
    « marihuana »
  • “marihuana” means the substance referred to as “Cannabis (marihuana)” in subitem 1(2) of Schedule II to the Controlled Drugs and Substances Act, other than marihuana that is sold or imported to be used for the purpose of a clinical trial, as that term is defined in section C.05.001 of the Food and Drug Regulations.

EXEMPTIONS

Exemption — Food and Drug Regulations

2. Marihuana is exempt from the application of the Food and Drug Regulations if it is

  • (a) produced by a licensed producer in accordance with the Marihuana for Medical Purposes Regulations; or
  • (b) imported or exported by a licensed producer in accordance with an import or export permit issued under those Regulations.

Exemption — Food and Drugs Act

3. Marihuana is exempt from the application of the Food and Drugs Act and the regulations made under it, other than these Regulations, if it is produced

  • (a) under contract with Her Majesty in right of Canada; or
  • (b) under a designated-person production licence, as defined in subsection 1(1) of the Marihuana Medical Access Regulations.

Contract with Her Majesty

4. Marihuana is exempt from the application of the Food and Drug Regulations if it is produced under contract with Her Majesty in right of Canada.

AMENDMENT TO THESE REGULATIONS

5. Section 3 of these Regulations is repealed.

REPEAL

6. The Marihuana Exemption (Food and Drugs Act) Regulations (see footnote 1) are repealed.

COMING INTO FORCE

Registration

7. (1) Subject to subsections (2) and (3), these Regulations come into force on the day on which they are registered.

April 1, 2014

(2) Section 4 comes into force on April 1, 2014.

March 31, 2014

(3) Section 5 comes into force on March 31, 2014.

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