Canada Gazette, Part I, Volume 155, Number 50: GOVERNMENT NOTICES

December 11, 2021

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Waiver of information requirements for living organisms (subsection 106(9) of the Canadian Environmental Protection Act, 1999)

Whereas, any person who proposes to import or manufacture a living organism that is not on the Domestic Substances List must provide to the Minister of the Environment the information required under subsection 106(1) of the Canadian Environmental Protection Act, 1999; and

Whereas, a person may, pursuant to subsection 106(8) of the Canadian Environmental Protection Act, 1999, request any of the requirements to provide information under subsection 106(1) of the Canadian Environmental Protection Act, 1999 to be waived.

Therefore, notice is hereby given, pursuant to subsection 106(9) of the Canadian Environmental Protection Act, 1999, that the Minister of the Environment waived some requirements to provide information in accordance with the following annex pursuant to subsection 106(8) of that Act.

Thomas Kruidenier
Acting Executive Director
Program Development and Engagement Division
On behalf of the Minister of the Environment

ANNEX

Notice of waiver of information requirements

(Subsection 106(9) of the Canadian Environmental Protection Act, 1999)
Person to whom a waiver was granted Information concerning a living organism in relation to which a waiver was granted
AstraZeneca Canada Inc.
  • Data from tests to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed (2) table a1 note 1
  • Data from tests to determine the effects of the living organism on terrestrial plant, invertebrate, and vertebrate species likely to be exposed (2)
  • Data from tests of antibiotic susceptibility (2)
CRISPR Therapeutics AG
  • Data from tests to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed
  • Data from tests to determine the effects of the living organism on terrestrial plant, invertebrate, and vertebrate species likely to be exposed
  • Data from tests of antibiotic susceptibility
Spark Therapeutics, Inc.
  • Data from tests to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed
  • Data from tests to determine the effects of the living organism on terrestrial plant, invertebrate, and vertebrate species likely to be exposed
  • Data from tests of antibiotic susceptibility
Ultragenyx Pharmaceutical, Inc.
  • Data from tests to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed
  • Data from tests to determine the effects of the living organism on terrestrial plant, invertebrate, and vertebrate species likely to be exposed
  • Data from tests of antibiotic susceptibility

Table a1 note(s)

Table a1 note 1

The number in brackets indicates the number of times that the information requirement in the second column was waived for the person.

Return to table a1 note 1 referrer

Explanatory note

The decision to grant a waiver is made on a case-by-case basis by the Minister of the Environment in consultation with the Minister of Health. Every year, approximately 450 regulatory declarations are submitted for chemicals, polymers and living organisms under subsections 81(1), (3) and (4) and 106(1), (3) and (4) of the Canadian Environmental Protection Act, 1999, and around 100 waivers are granted yearly for chemicals, polymers and living organisms under subsections 81(8) and 106(8) of the Canadian Environmental Protection Act, 1999.

For more information, please see the waivers web page on the New Substances website.

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999)

Whereas any person who proposes to import or manufacture a substance that is not on the Domestic Substances List must provide to the Minister of the Environment the information required under subsection 81(1) of the Canadian Environmental Protection Act, 1999; and

Whereas a person may, pursuant to subsection 81(8) of the Canadian Environmental Protection Act, 1999, request any of the requirements to provide information under subsection 81(1) of the Canadian Environmental Protection Act, 1999 to be waived;

Therefore, notice is hereby given, pursuant to subsection 81(9) of the Canadian Environmental Protection Act, 1999, that the Minister of the Environment waived some requirements to provide information pursuant to subsection 81(8) of that Act and in accordance with the following annex.

Thomas Kruidenier
Acting Executive Director
Program Development and Engagement Division

On behalf of the Minister of the Environment

ANNEX

Waiver of information requirements

(Subsection 81(9) of the Canadian Environmental Protection Act, 1999)
Person to whom a waiver was granted Information concerning a substance in relation to which a waiver was granted
Brenntag Canada Inc. Data from a ready biodegradation test
H.B. Fuller Canada
  • Data in respect of octanol/water partition coefficient (2) table a2 note 1
  • Data in respect of hydrolysis rate as a function of pH (2)
  • Data in respect of water extractability(2)
Michelin North America (Canada) Inc.
  • Data from an adsorption-desorption screening test
  • Data in respect of hydrolysis rate as a function of pH
Nouryon Functional Chemicals LLC
  • Data in respect of melting point
  • Data in respect of boiling point
Otsuka Canada Pharmaceutical Inc.
  • Data in respect of vapour pressure
  • Data in respect of octanol/water partition coefficient
  • Data from a ready biodegradation test
  • Data from an acute fish, daphnia or algae toxicity test
Ricoh Canada Inc.
  • Data in respect of number average molecular weight (Mn)
  • Data in respect of maximum concentrations, expressed in percentage, of all residual constituents having a molecular weight less than 500 daltons and of all residual constituents having a molecular weight less than 1 000 daltons
Water Specialists Technologies, LLC
  • Data in respect of melting point
  • Data in respect of boiling point
  • Data in respect of vapour pressure
  • Data from a ready biodegradation test
  • Data from an adsorption-desorption screening test
  • Data in respect of hydrolysis rate as a function of pH

Table a2 note(s)

Table a2 note 1

The number in brackets indicates the number of times that the information requirement in the second column was waived for the person.

Return to table a2 note 1 referrer

EXPLANATORY NOTE

The decision to grant a waiver is made on a case-by-case basis by the Minister of the Environment in consultation with the Minister of Health. Every year, approximately 450 regulatory declarations are submitted for chemicals, polymers and living organisms under subsections 81(1), (3) and (4) and 106(1), (3) and (4) of the Canadian Environmental Protection Act, 1999, and around 100 waivers are granted yearly for chemicals, polymers and living organisms under subsections 81(8) and 106(8) of the Canadian Environmental Protection Act, 1999.

For more information, please see the waivers web page on the New Substances website.

DEPARTMENT OF THE ENVIRONMENT

CANADIAN NET-ZERO EMISSIONS ACCOUNTABILITY ACT

Publication notice of the 2030 emissions reduction plan

Notice is hereby given, pursuant to subsection 9(3) of the Canadian Net-Zero Emissions Accountability Act (the Act), that the Minister of Environment and Climate Change will establish Canada’s 2030 emissions reduction plan no later than March 29, 2022.

Pursuant to section 13 of the Act, when establishing an emissions reduction plan, the Minister must, in the manner the Minister consider appropriate, provide the governments of the provinces, Indigenous Peoples, the net-zero advisory body, and interested persons with the opportunity to make submissions. Early consultations, supported by a series of discussion papers, will be launched before the end of 2021, prioritizing the following new commitments:

Public participation is an integral part of the Government’s inaugural emissions reduction plan. The decision to extend the time limit to establish Canada’s 2030 emissions reduction plan by 90 days, from six months after the day on which the Act came into force (June 29, 2021) to March 29, 2022, will therefore provide a greater amount of time to seek and receive submissions from key partners, stakeholders, and Canadians.

Those who are interested in making a submission specific to the 2030 emissions reduction plan can do so online at the Environment and Climate Change Canada website. Submissions will be accepted until January 14, 2022.

Douglas Nevison
Acting Assistant Deputy Minister
Climate Change Branch
On behalf of the Minister of Environment and Climate Change

DEPARTMENT OF HEALTH

DEPARTMENT OF HEALTH ACT

Notice of annual increase of Health Canada’s Drug Master Files and Certificate of Pharmaceutical Product fees

Notice is hereby given that the Minister of Health, under the Ministerial Authority to Enter into Contract, updates the fees that are payable for the provision of Drug Master Files and Certificate of Pharmaceutical Product services by 2%.

The current fees and the fees updated as of April 1, 2022, are listed below.

Any inquiries or comments about the updated fees can be directed to Etienne Ouimette, Director General, Resource Management and Operations Directorate, Health Products and Food Branch, 613‑957‑6690 (telephone) or cro-brc@hc-sc.gc.ca (email).

Annual increase of Drug Master Files and Certificate of Pharmaceutical Product fees
Services Fee as of April 1, 2021 Fee as of April 1, 2022
Certificate of Pharmaceutical Product (or a supplemental copy of a Certificate of Pharmaceutical Product) $94 $96
New Master Files (file registration) $1,298 $1,324
Drug Master Files — letter of access $184 $188
Drug Master Files — update $563 $575

DEPARTMENT OF HEALTH

FINANCIAL ADMINISTRATION ACT

Notice of annual adjustment of fees for dealer’s licences

Notice is hereby given, under section 19.2 of the Financial Administration Act, that in keeping with section 4 of the Fees in Respect of Dealer’s Licences Regulations, the fee for dealer’s licences: human drugs will increase by the annual 2% amount, rounded up to the nearest dollar. Under subsection 17(1) of the Service Fees Act (a fee is adjusted in each fiscal year — on the anniversary of a date that is selected by the responsible authority with respect to the fee before the first adjustment — by the percentage change over 12 months in the April All-items Consumer Price Index [CPI] for Canada, as published by Statistics Canada under the Statistics Act, for the previous fiscal year), the dealer’s licence: veterinary drugs (as per the Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations) will be adjusted by the CPI. Health Canada has chosen April 1 as the anniversary date. The CPI for this year is 3.4%.

The current fees and the fees updated as of April 1, 2022, are listed below.

Any inquiries or comments about the updated fees can be directed to Etienne Ouimette, Director General, Resource Management and Operations Directorate, Health Products and Food Branch, 613‑957‑6690 (telephone) or cro-brc@hc-sc.gc.ca (email).

Annual adjustment of fees for dealer’s licences
Type of licence Fee as of April 1, 2021 Fee as of April 1, 2022
Dealer’s licence (human drugs) $5,502 $5,613
Dealer’s licence (veterinary drugs) $1,820.62 $1,882.52

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Notice of annual adjustment of the Fees in Respect of Drugs and Medical Devices Order

Notice is hereby given, under subsection 30.61(1) of the Food and Drugs Act, that in keeping with section 4.1 of the 2020 Fees in Respect of Drugs and Medical Devices Order, every fee outlined in the Order is to be adjusted annually based on the Consumer Price Index (CPI). The CPI is calculated based on the percentage change over 12 months in the April All-items CPI for Canada, as published by Statistics Canada under the Statistics Act, for the previous fiscal year. The CPI for this year is 3.4%.

Most fees in the Fees in Respect of Drugs and Medical Devices Order are currently being phased in over four or seven years.

The current fees and the fees updated as of April 1, 2022, are listed below.

Any inquiries or comments about the updated fees can be directed to Etienne Ouimette, Director General, Resource Management and Operations Directorate, Health Products and Food Branch, 613‑957‑6690 (telephone) or cro-brc@hc-sc.gc.ca (email).

Human Drug Submission Review

Part 2 — Drugs

Table 1: Fees for examination of a submission — drugs for human use (Schedule 1)
Section in the Fees in Respect of Drugs and Medical Devices Order Submission class Fee as of April 1, 2021 Fee as of April 1, 2022
Section 9 New active substance $437,009 $490,666
Clinical or non-clinical data and chemistry and manufacturing data $224,242 $253,015
Clinical or non-clinical data only $95,796 $104,339
Comparative studies $55,737 $59,708
Chemistry and manufacturing data only $30,609 $34,831
Clinical or non-clinical data only, in support of safety updates to the labelling $19,404 $20,064
Labelling only $4,320 $4,997
Labelling only (generic drugs) $2,006 $2,075
Administrative submission $539 $698
Disinfectant — full review $7,126 $9,211
Labelling only (disinfectants) $2,502 $2,588
Drug identification number application — labelling standard $1,613 $1,668
Table 2: Fees for examination of a submission — drugs for veterinary use only (Schedule 2)
Section in the Fees in Respect of Drugs and Medical Devices Order Type of submission Component Fee as of April 1, 2021 Fee as of April 1, 2022
Section 21 Application for drug identification number (DIN) Information, other than that referred to in the item below, to support an application for a drug identification number, including the submission of labelling material for a second review, if required $1,146 $1,483
Published references or other data $797 $1,031
Documentation to support a change of manufacturer, a change to the name of a manufacturer or a change to the brand name of a drug $400 $516
Notification — veterinary health product Information contained in a notification filed under subsection C.01.615(1) of the Food and Drug Regulations in respect of a veterinary health product $486 $503
New drug submissions (NDS) Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in one animal species (in the case of an antiparasitic drug, several indications in one food animal species) $25,419 $32,855
Efficacy and safety data (in the intended species) to support a single route of administration and dosage form for an antiparasitic drug in one non-food animal species $15,398 $19,903
Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in two animal species, or a single route of administration and dosage form and two indications in one animal species $36,966 $47,780
Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species $50,057 $64,700
Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration $4,614 $5,965
Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength $764 $989
For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species $34,660 $44,800
For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of less than 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species $46,208 $59,724
For food-producing animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route of administration $4,614 $5,965
For food-producing animals (once an acceptable daily intake with a safety factor of 1,000 or less has been established), metabolism and residue depletion studies to establish a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in an additional species $23,096 $29,853
Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug $7,700 $9,953
Chemistry and manufacturing data to support one strength of a single dosage form $7,700 $9,953
Chemistry and manufacturing data to support an additional strength of a single dosage form submitted at the same time as the item above $3,851 $4,978
Documentation to support a change of manufacturer $400 $516
Supplement to a new drug submission (SNDS) Efficacy data to support an additional indication in one animal species $20,027 $25,886
Efficacy and safety data (in the intended species) to support a single route of administration and dosage form for an antiparasitic drug in one non-food animal species $15,398 $19,903
Efficacy and safety data (in the intended species) to support an indication in another animal species $25,419 $32,855
Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in two animal species, or a single route of administration and dosage form and two indications in one animal species $36,966 $47,780
Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species $50,057 $64,700
Efficacy and safety data (in the intended species) to support the concurrent use of two drugs approved for the same animal species $12,312 $15,915
Comparative (pharmacodynamic, clinical or bioavailability) data to support an additional route of administration $4,614 $5,965
Comparative (pharmacodynamic, clinical or bioavailability) data to support each additional strength $764 $989
For food-producing animals, residue depletion studies to establish a new withdrawal period for a change in the dosage or route of administration of an approved dosage form in one species $4,614 $5,965
For food-producing animals, metabolism and residue depletion studies to establish a maximum residue limit and a withdrawal period for a single dosage and route of administration of an approved dosage form in an additional species $23,096 $29,853
For food-producing animals, toxicity studies to support a change of an established acceptable daily intake, a maximum residue limit and a withdrawal period $11,548 $14,927
For the concurrent use of two drugs in a species of food-producing animals, residue depletion studies to determine if an extension to existing withdrawal periods is required $9,243 $11,946
Chemistry and manufacturing data to support a change in the source of a medicinal ingredient or its manufacturing process $7,700 $9,953
Chemistry and manufacturing data to support a change in formulation or dosage form $3,851 $4,978
Chemistry and manufacturing data to support a change in the packaging or sterilization process $3,072 $3,972
Chemistry and manufacturing data to support an extension of the expiry date $2,309 $2,985
Chemistry and manufacturing data to support the concurrent use of two drugs $2,309 $2,985
Chemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage form $764 $989
Documentation to support a change to the brand name of a drug $400 $516
Abbreviated new drug submission (ANDS) or supplement to an abbreviated new drug submission (SANDS) Comparative (pharmacodynamic, clinical or bioavailability) data to support a single route of administration and dosage form $4,614 $5,965
For food-producing animals, residue depletion studies to confirm that the withdrawal periods for each species fall within the conditions of use for the Canadian reference product $4,614 $5,965
Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug $7,700 $9,953
Chemistry and manufacturing data to support a single dosage form $7,700 $9,953

Documentation to support

(a) a change of manufacturer, in the case of an abbreviated new drug submission;

or

(b) a change to the brand name of a drug, in the case of a supplement to an abbreviated new drug submission

 $400 $516
Preclinical submission Efficacy and safety data (in the intended species) and protocol to support the conduct of clinical studies relative to a single dosage form, route of administration and indication in one species $7,700 $9,953
Efficacy data and protocol to support the conduct of clinical studies relative to a single route of administration and indication with a dosage form for which a notice of compliance has been issued for use in the species to be treated $6,157 $7,959
For food-producing animals, toxicity, metabolism and residue depletion studies to establish a temporary acceptable daily intake, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species $23,096 $29,853
For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species $34,660 $44,800
For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of less than 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species $46,208 $59,724
For food-producing animals (once an acceptable daily intake with a safety factor of 1,000 or less has been established), metabolism studies to establish a withdrawal period for a single dosage form, dosage and route of administration in an additional species $11,548 $14,927
Chemistry and manufacturing data to support a single dosage form containing a non-compendial medicinal ingredient $7,700 $9,953
Chemistry and manufacturing data to support a single dosage form containing a compendial medicinal ingredient $3,851 $4,978
Sale of new drug for emergency treatment Information and material to support the sale of a new drug to be used in the emergency treatment of a non-food-producing animal $51 $53
Information and material to support the sale of a new drug to be used in the emergency treatment of a food-producing animal $102 $106
Experimental studies certificate Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a non-food-producing animal $979 $1,013
Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that of a previously authorized experimental studies certificate for a drug to be administered to a non-food-producing animal $490 $507
Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a food-producing animal $2,953 $3,054
Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that of a previously authorized experimental studies certificate for a drug to be administered to a food-producing animal $490 $507
Notifiable change or protocol review Information and material to support an application for a notifiable change $2,069 $2,674
A protocol that is filed with the Minister and may support a new drug submission, an abbreviated new drug submission, a supplement to a new drug submission or abbreviated new drug submission, a preclinical submission or information and material that is filed for the purpose of obtaining an experimental studies certificate $2,069 $2,674
Table 3: Fees for examination of an application for an establishment licence — drugs for human use (Schedule 3)
Section in the Fees in Respect of Drugs and Medical Devices Order Activity Fee as of April 1, 2021 Fee as of April 1, 2022
Sections 33 and 41 Fabrication — sterile dosage form $41,647 $43,171
Sections 34 and 42 Importation $28,975 $31,688
Sections 35 and 43 Fabrication — non-sterile dosage form $28,308 $30,677
Sections 36 and 44 Distribution $13,855 $15,691
Sections 37 and 45 Wholesaling $6,159 $7,962
Sections 38 and 46 Packaging/labelling $6,049 $6,225
Sections 39 and 47 Testing $3,194 $4,129
Section 40 Foreign site (each) $917 $949
Table 4: Fees for examination of an application for an establishment licence — drugs for veterinary use only (Schedule 4)
Section in the Fees in Respect of Drugs and Medical Devices Order Activity Fee as of April 1, 2021 Fee as of April 1, 2022
Sections 33 and 41 Fabrication — sterile dosage form $40,407 $42,080
Sections 34 and 42 Importation $13,367 $17,278
Sections 35 and 43 Fabrication — non-sterile dosage form $10,957 $14,161
Sections 36 and 44 Distribution $6,031 $7,797
Sections 37 and 45 Wholesaling $2,412 $3,117
Sections 38 and 46 Packaging/labelling $6,049 $6,255
Sections 39 and 47 Testing $1,641 $2,121
Section 40 Foreign site (each) $917 $949
Table 5: Fees for right to sell drugs for human use (Schedule 6)
Section in the Fees in Respect of Drugs and Medical Devices Order Type of drug Fee as of April 1, 2021 Fee as of April 1, 2022
Section 52 Disinfectant $1,342 $1,449
Non-prescription $2,018 $2,500
Drug other than one referred to in item 1 or 2 (above) $2,749 $4,211
Table 6: Fees for right to sell drugs for veterinary use only (Schedule 7)
Section in the Fees in Respect of Drugs and Medical Devices Order Type of drug Fee as of April 1, 2021 Fee as of April 1, 2022
Section 56 Veterinary drug $367 $437

Part 3 — Medical devices

Table 7: Fees for examination of an application for a medical device licence (Schedule 8)
Section in the Fees in Respect of Drugs and Medical Devices Order Category Fee as of April 1, 2021 Fee as of April 1, 2022
Section 60 Applications for Class II licence $478 $522
Applications for Class II licence amendment $272 $282
Applications for Class III licence $8,895 $10,679
Applications for Class III licence (near patient) $16,032 $20,723
Applications for Class III licence amendment — changes in manufacturing $2,375 $3,070
Applications for Class III licence amendment — significant changes not related to manufacturing $7,543 $8,780
Applications for Class IV licence $24,699 $25,955
Applications for Class IV licence amendment — changes in manufacturing $2,375 $3,070
Applications for Class IV licence amendment — significant changes not related to manufacturing $9,964 $12,128
Applications for Class II, III or Class IV licence or licence amendment — private label medical device $147 $152
Table 8: Fees for examination of an application for an establishment licence — medical devices
Section in the Fees in Respect of Drugs and Medical Devices Order Fee category Fee as of April 1, 2021 Fee as of April 1, 2022
Section 71 Medical device $4,581 $4,737
Table 9: Fees for right to sell licensed Class II, III or IV medical devices
Section in the Fees in Respect of Drugs and Medical Devices Order Fee category Fee as of April 1, 2021 Fee as of April 1, 2022
Section 77 Medical device $381 $394

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Notice of intent — Consultation on modernizing the medical device and drug establishment licensing frameworks (Phase I)

Introduction

This notice provides interested stakeholders with information and an opportunity to comment on Health Canada’s intent to modernize elements of the Medical Devices Regulations (MDR) and the Food and Drug Regulations (FDR), related to compliance and enforcement oversight, as outlined in the Health and Biosciences Sector Regulatory Review Roadmap.

A phased approach is being taken to modernize the MDR and the FDR to address stakeholder feedback. This feedback notes that elements of the frameworks limit Health Canada’s ability to foster an innovative and competitive business environment, and are not aligned with other jurisdictions. More recently, stakeholders have also indicated an interest in continuing certain measures introduced as part of Health Canada’s response to the COVID-19 pandemic.

Amendments to the MDR and the FDR are needed to strengthen Health Canada’s ability to provide efficient, effective, and agile oversight of medical devices and drugs. Health Canada intends to use feedback received from this notice and subsequent opportunities for stakeholder engagement to better inform outstanding proposed regulatory, policy, and program considerations.

Background

Medical devices

Health Canada issues medical device establishment licences (MDELs) to manufacturers of Class I devices, as well as importers and distributors of all four device classes, to permit importation or distribution (sale) of a medical device in Canada. Health Canada requires MDEL holders to (i) identify the manufacturers and classes of medical devices imported and distributed within Canada, (ii) provide assurances they have met regulatory requirements set out in the MDR, and (iii) ensure procedures are in place to protect the public, should a problem with a device be identified.

Under the current MDR, Health Canada has limited tools to address issues of non-compliance in an agile and targeted manner. If non-compliance with the MDR is detected, Health Canada applies its enforcement tools to all licensable activities. Health Canada does not have the authority to take targeted and risk-based action to address the specific aspect of non-compliance. This has led to a misalignment with other jurisdictions and can impact the supply of medical devices, create administrative burden, and affect competitiveness.

Drugs

Similar to medical devices, a drug establishment licence (DEL) is issued to a person who conducts a licensable activity with a drug, such as manufacturing, packaging, labelling, testing, importing, distributing and wholesaling. A DEL is issued on the basis of a company’s ability to meet good manufacturing practices (GMP) requirements, with additional considerations for certain drugs coming from or destined to countries which hold an agreement with Health Canada, referred to as “designated regulatory authorities.” Meeting GMP requirements can be demonstrated in diverse ways, including the use of evidence from foreign regulators for which Canada has Mutual Recognition Agreements (MRAs). Maintaining an updated list of designated regulatory authorities through regulations presents a challenge, given the collaborative approach that Canada fosters.

Some of the current requirements of the FDR can present a regulatory burden to importers, particularly those who conduct regulated activities with novel and complex therapeutic products (e.g. certain biologics and radiopharmaceuticals) which can impact patient access.

Additionally, Health Canada relies on recalls to address and correct issues that present risks to consumers. Stakeholders have raised that the timelines and expectations that they have to meet for reporting recalls for drugs are unclear and create administrative burden on industry.

Proposal — Phase I

Medical Devices Regulations

Heath Canada is proposing amendments to the MDR that would allow Canada to take a more strategic and risk-based approach to compliance and enforcement oversight for MDELs. The department is also proposing to improve the effectiveness of medical devices recalls in Canada by providing clarity to industry on its roles and responsibilities for conducting firm-initiated (voluntary) recalls.

The modernization of the medical device and drug establishment licensing frameworks (Phase I) proposes to make targeted amendments to the MDR. It is comprised of three components:

Food and Drug Regulations

The proposed amendments to the FDR would include components respecting DEL, GMP and recall reporting to take a more agile, risk-based approach to compliance and enforcement oversight for drugs and reduce regulatory and operational burden. The proposed amendments for drugs would

Provincial and territorial laws or regulations

This proposal would not limit any provincial or territorial law or regulation, including any professional regulations enacted in accordance with a provincial or territorial enabling statute.

Next steps

Results of this consultation will be used to support Health Canada’s prepublication in the Canada Gazette, Part I. Canadians will also have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I, public comment period, which is expected to take place in fall 2022.

Health Canada anticipates final publication of Phase I regulatory amendments in the Canada Gazette, Part II, in fall 2023.

Policy development is underway for a Phase II regulatory package to further modernize the establishment licensing frameworks under the MDR and the FDR. Further information will be provided in Health Canada’s Forward Regulatory Plan.

Public comment period

Interested parties may, within 60 days of publication of this notice, provide their comments on this notice of intent, in English or in French, in writing by email (hc.prsd-questionsdspr.sc@canada.ca) to Danny Lepage, Associate Director, Compliance Policy and Regulatory Affairs, Policy and Regulatory Strategies Directorate, 200 Eglantine Driveway, Ottawa, Ontario K1A 0K9. All comments or inquiries submitted must state the title of this notice of intent [Notice of intent — Consultation on modernizing the medical device and drug establishment licensing frameworks (Phase I)] in the subject line.

Health Canada will also distribute a cost-benefit analysis survey for interested parties’ feedback with the same 60-day comment period.

Danny Lepage
Associate Director
Compliance Policy and Regulatory Affairs
Regulatory Operations and Enforcement Branch

DEPARTMENT OF HEALTH

PATENT ACT

Notice of annual increase of fee pursuant to the Certificate of Supplementary Protection Regulations

Notice is hereby given, that in keeping with subsection 9(1) of the Certificate of Supplementary Protection Regulations, the fee will increase by the annual 2% amount, rounded up to the nearest dollar.

The current fee and the fee updated as of April 1, 2022, are listed below.

Any inquiries or comments about the updated fee can be directed to Etienne Ouimette, Director General, Resource Management and Operations Directorate, Health Products and Food Branch, 613‑957‑6690 (telephone) or cro-brc@hc-sc.gc.ca (email).

Annual increase of fee pursuant to Certificate of Supplementary Protection Regulations
Type of certificate Subsection in Certificate of Supplementary Protection Regulations Fee as of April 1, 2021 Fee as of April 1, 2022
Certificate of Supplementary Protection 9(1) $9,756 $9,952

DEPARTMENT OF TRANSPORT

AERONAUTICS ACT

Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 45

Whereas the annexed Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 45 is required to deal with a significant risk, direct or indirect, to aviation safety or the safety of the public;

Whereas the provisions of the annexed Order may be contained in a regulation made pursuant to sections 4.71footnote a and 4.9footnote b, paragraphs 7.6(1)(a)footnote c and (b)footnote d and section 7.7footnote e of the Aeronautics Actfootnote f;

And whereas, pursuant to subsection 6.41(1.2)footnote g of that Act, the Deputy Minister of Transport has consulted with the persons and organizations that that Minister considers appropriate in the circumstances before making the annexed Order;

Therefore, the Deputy Minister of Transport, pursuant to subsection 6.41(1.1)footnote g of the Aeronautics Act footnote f, makes the annexed Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 45.

Ottawa, November 23, 2021

Michael Keenan
Deputy Minister of Transport

Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 45

Interpretation

Definitions

1 (1) The following definitions apply in this Interim Order.

aerodrome property
means, in respect of an aerodrome listed in Schedule 2, any air terminal buildings, restricted areas or facilities used for activities related to aircraft operations that are located at the aerodrome. (terrains de l’aérodrome)
aerodrome security personnel
has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (personnel de sûreté de l’aérodrome)
air carrier
means any person who operates a commercial air service under Subpart 1, 3, 4 or 5 of Part VII of the Regulations. (transporteur aérien)
COVID-19
means the coronavirus disease 2019. (COVID-19)
COVID-19 molecular test
means a COVID-19 screening or diagnostic test carried out by an accredited laboratory, including a test performed using the method of polymerase chain reaction (PCR) or reverse transcription loop-mediated isothermal amplification (RT-LAMP). (essai moléculaire relatif à la COVID-19)
document of entitlement
has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (document d’autorisation)
foreign national
means a person who is not a Canadian citizen or a permanent resident and includes a stateless person. (étranger)
non-passenger screening checkpoint
has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (point de contrôle des non-passagers)
passenger screening checkpoint
has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (point de contrôle des passagers)
peace officer
has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (agent de la paix)
Regulations
means the Canadian Aviation Regulations. (Règlement)
restricted area
has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (zone réglementée)
screening authority
means a person responsible for the screening of persons and goods at an aerodrome set out in the schedule to the CATSA Aerodrome Designation Regulations or at any other place designated by the Minister under subsection 6(1.1) of the Canadian Air Transport Security Authority Act. (administration de contrôle)
screening officer,
except in section 2, has the same meaning as in section 2 of the Canadian Air Transport Security Authority Act. (agent de contrôle)

Interpretation

(2) Unless the context requires otherwise, all other words and expressions used in this Interim Order have the same meaning as in the Regulations.

Conflict

(3) In the event of a conflict between this Interim Order and the Regulations or the Canadian Aviation Security Regulations, 2012, the Interim Order prevails.

Definition of face mask

(4) For the purposes of this Interim Order, a face mask means any mask, including a non-medical mask that meets all of the following requirements:

Face masks — lip reading

(5) Despite paragraph (4)(a), the portion of a face mask in front of a wearer’s lips may be made of transparent material that permits lip reading if

Definition of fully vaccinated person

(6) For the purposes of this Interim Order, a fully vaccinated person means a person who completed, at least 14 days before the day on which they access aerodrome property or a location where NAV CANADA provides civil air navigation services, a COVID-19 vaccine dosage regimen if

Interpretation — fully vaccinated person

(7) For greater certainty, for the purposes of the definition fully vaccinated person in subsection (6), a COVID-19 vaccine that is authorized for sale in Canada does not include a similar vaccine sold by the same manufacturer that has been authorized for sale in another jurisdiction.

Notification

Federal, provincial and territorial measures

2 (1) A private operator or air carrier operating a flight between two points in Canada or a flight to Canada departing from any other country must notify every person boarding the aircraft for the flight that they may be subject to measures to prevent the spread of COVID-19 taken by the provincial or territorial government with jurisdiction where the destination aerodrome for that flight is located or by the federal government.

Suitable quarantine plan

(2) A private operator or air carrier operating a flight to Canada departing from any other country must notify every person before the person boards the aircraft for the flight that they may be required, under an order made under section 58 of the Quarantine Act, to provide, before boarding the aircraft, to the Minister of Health, a screening officer or a quarantine officer, by the electronic means specified by that Minister, a suitable quarantine plan or, if the person is not required under that order to provide the plan and the evidence, their contact information. The private operator or air carrier must also notify every person that they may be liable to a fine if this requirement applies to them and they fail to comply with it.

Vaccination

(3) A private operator or air carrier operating a flight to Canada departing from any other country must notify every person before the person boards the aircraft for the flight that they may be required, under an order made under section 58 of the Quarantine Act, to provide, before boarding the aircraft or before entering Canada, to the Minister of Health, a screening officer or a quarantine officer, by the electronic means specified by that Minister, information related to their COVID-19 vaccination and evidence of COVID-19 vaccination. The private operator or air carrier must also notify every person that they may be denied permission to board the aircraft and may be liable to a fine if this requirement applies to them and they fail to comply with it.

False confirmation

(4) A private operator or air carrier operating a flight between two points in Canada or a flight to Canada departing from any other country must notify every person boarding the aircraft for the flight that they may be liable to a monetary penalty if they provide a confirmation referred to in subsection 3(1) that they know to be false or misleading.

Definitions

(5) The following definitions apply in this section.

quarantine officer
means a person designated as a quarantine officer under subsection 5(2) of the Quarantine Act. (agent de quarantaine)
screening officer
has the same meaning as in section 2 of the Quarantine Act. (agent de contrôle)

Confirmation

Federal, provincial and territorial measures

3 (1) Before boarding an aircraft for a flight between two points in Canada or a flight to Canada departing from any other country, every person must confirm to the private operator or air carrier operating the flight that they understand that they may be subject to a measure to prevent the spread of COVID-19 taken by the provincial or territorial government with jurisdiction where the destination aerodrome for that flight is located or by the federal government.

False confirmation

(2) A person must not provide a confirmation referred to in subsection (1) that they know to be false or misleading.

Exception

(3) A competent adult may provide a confirmation referred to in subsection (1) on behalf of a person who is not a competent adult.

Prohibition

4 A private operator or air carrier operating a flight between two points in Canada or a flight to Canada departing from any other country must not permit a person to board the aircraft for the flight if the person is a competent adult and does not provide a confirmation that they are required to provide under subsection 3(1).

Foreign Nationals

Prohibition

5 A private operator or air carrier must not permit a foreign national to board an aircraft for a flight that the private operator or air carrier operates to Canada departing from any other country.

Exception

6 Section 5 does not apply to a foreign national who is permitted to enter Canada under an order made under section 58 of the Quarantine Act.

Health Check

Non-application

7 Sections 8 to 10 do not apply to either of the following persons:

Health check

8 (1) A private operator or air carrier must conduct a health check of every person boarding an aircraft for a flight that the private operator or air carrier operates by asking questions to verify whether they exhibit any of the following symptoms:

Notification

(2) A private operator or air carrier must notify every person boarding an aircraft for a flight that the private operator or air carrier operates that the person may be denied permission to board the aircraft if

Confirmation

(3) Every person boarding an aircraft for a flight that a private operator or air carrier operates must confirm to the private operator or air carrier that none of the following situations apply to them:

False confirmation — obligation of private operator or air carrier

(4) The private operator or air carrier must advise every person that they may be liable to a monetary penalty if they provide answers, with respect to the health check or a confirmation, that they know to be false or misleading.

False confirmation — obligations of person

(5) A person who, under subsections (1) and (3), is subjected to a health check and is required to provide a confirmation must

Exception

(6) A competent adult may answer all questions and provide a confirmation on behalf of a person who is not a competent adult and who, under subsections (1) and (3), is subjected to a health check and is required to give a confirmation.

Observations — private operator or air carrier

(7) During the boarding process for a flight that the private operator or air carrier operates, the private operator or air carrier must observe whether any person boarding the aircraft is exhibiting any symptoms referred to in subsection (1).

Prohibition

9 A private operator or air carrier must not permit a person to board an aircraft for a flight that the private operator or air carrier operates if

Period of 14 days

10 A person who is not permitted to board an aircraft under section 9 is not permitted to board another aircraft for a period of 14 days after the denial, unless they provide a medical certificate certifying that any symptoms referred to in subsection 8(1) that they are exhibiting are not related to COVID-19.

COVID-19 Molecular Test — Flights to Canada

Application

11 (1) Sections 12 to 17 apply to a private operator or air carrier operating a flight to Canada departing from any other country and to every person boarding an aircraft for such a flight.

Non-application

(2) Sections 12 to 17 do not apply to persons who are not required under an order made under section 58 of the Quarantine Act to provide evidence that they received a result for a COVID-19 molecular test.

Notification

12 A private operator or air carrier must notify every person who intends to board an aircraft for a flight that the private operator or air carrier operates that the person may be denied permission to board the aircraft if they are unable to provide evidence that they received a result for a COVID-19 molecular test.

Evidence — result of test

13 (1) Before boarding an aircraft for a flight, every person must provide to the private operator or air carrier operating the flight evidence that they received either

Evidence — location of test

(2) For the purposes of subsection (1), the COVID-19 molecular test must have been performed in a country or territory that is not listed in Schedule 1.

Evidence — elements

14 Evidence of a result for a COVID-19 molecular test must include

False or misleading evidence

15 A person must not provide evidence of a result for a COVID-19 molecular test that they know to be false or misleading.

Notice to Minister

16 A private operator or air carrier that has reason to believe that a person has provided evidence of a result for a COVID-19 molecular test that is likely to be false or misleading must notify the Minister as soon as feasible of the person’s name and contact information and the date and number of the person’s flight.

Prohibition

17 A private operator or air carrier must not permit a person to board an aircraft for a flight that the private operator or air carrier operates if the person does not provide evidence that they received a result for a COVID-19 molecular test in accordance with the requirements set out in section 13.

Vaccination or COVID-19 Molecular Test — Flights Departing from an Aerodrome in Canada

Application

17.1 (1) Sections 17.2 to 17.17 apply to all of the following persons:

Non-application

(2) Sections 17.2 to 17.17 do not apply to any of the following persons:

Notification

17.2 An air carrier must notify every person who intends to board an aircraft for a flight that the air carrier operates that they

Confirmation

17.3 (1) Before boarding an aircraft for a flight, every person must confirm to the air carrier operating the flight that they

Exception

(2) A competent adult may provide a confirmation referred to in subsection (1) on behalf of a person who is not a competent adult.

Exception — person less than 16 years of age

(3) Subsection (1) does not apply to a person who is less than 16 years of age and who is travelling alone.

Prohibition — person

17.4 (1) A person is prohibited from boarding an aircraft for a flight or entering a restricted area unless

Exception

(2) Subsection (1) does not apply to a person who is boarding the aircraft for a flight to an aerodrome in Canada if the initial scheduled departure time of that flight is not more than 24 hours after the departure time of a flight taken by the person to Canada from any other country.

Request for evidence — air carrier

17.5 (1) Before permitting a certain number of persons, as specified by the Minister and selected on a random basis, to board an aircraft for a flight that the air carrier operates, the air carrier must request that each of those persons provide

Person less than 16 years of age

(2) An air carrier must request that every person described in subsection 17.3(3) provide, before they board an aircraft for a flight that the air carrier operates, the evidence referred to in paragraph (1)(a), (b) or (c).

Request for evidence — screening authority

17.6 Before permitting a certain number of persons, as specified by the Minister and selected on a random basis, to enter a restricted area, the screening authority must request that each of those persons, when they present themselves for screening at a passenger screening checkpoint, provide the evidence referred to in paragraph 17.5(1)(a), (b) or (c).

Provision of evidence

17.7 A person must, at the request of an air carrier or a screening authority, provide to the air carrier or screening authority the evidence referred to in paragraph 17.5(1)(a), (b) or (c).

Evidence of vaccination — elements

17.8 (1) Evidence of COVID-19 vaccination must be evidence issued by the government or the non-governmental entity that is authorized to issue it in the jurisdiction in which the vaccine was administered and must contain the following information:

Evidence of vaccination — translation

(2) The evidence of COVID-19 vaccination must be in English or French and any translation into English or French must be a certified translation.

Evidence of COVID-19 molecular test — result

17.9 (1) A result for a COVID-19 molecular test is a result described in paragraph 13(1)(a) or (b).

Evidence of COVID-19 molecular test — elements

(2) Evidence of a result for a COVID-19 molecular test must include the elements set out in paragraphs 14(a) to (d).

Evidence — person referred to in subsection 17.4(2)

17.10 Evidence that the person is a person referred to in subsection 17.4(2) means a travel itinerary or boarding pass that shows that the initial scheduled departure time of the person’s flight to an aerodrome in Canada is not more than 24 hours after the departure time of a flight taken by the person to Canada from any other country.

False or misleading confirmation or evidence

17.11 A person must not provide a confirmation or evidence that they know to be false or misleading.

Notice to Minister

17.12 An air carrier or screening authority that has reason to believe that a person has provided a confirmation or evidence that is likely to be false or misleading must notify the Minister of the person’s name and contact information and the date and number of the person’s flight not more than 72 hours after the provision of the confirmation or evidence.

Prohibition — air carrier

17.13 (1) An air carrier must not permit a person to board an aircraft for a flight that the air carrier operates if

Notification to person

(2) An air carrier that denies a person permission to board an aircraft under paragraph (1)(b) must notify the person that

Prohibition — screening authority

17.14 (1) A screening authority must not permit a person to enter a restricted area if the person does not provide the evidence they are required to provide under section 17.7.

Notification to person

(2) A screening authority that denies a person entry to a restricted area under subsection (1) must notify the person that

Notification to air carrier

(3) If a screening authority denies a person entry to a restricted area, the screening authority must notify the air carrier operating the flight that the person has been denied entry and provide the person’s name and flight number to the air carrier.

Air carrier requirements

(4) An air carrier that has been notified under subsection (3) must ensure that the person is escorted to a location where they can retrieve their checked baggage, as defined in section 3 of the Canadian Aviation Security Regulations, 2012, if applicable.

Prohibition — boarding an aircraft

17.15 (1) A person who is denied permission to board an aircraft under paragraph 17.13(1)(b) is not permitted to board an aircraft for a flight departing from Canada for a period of 72 hours after the denial.

Prohibition — entry to restricted area

(2) A person who is denied entry to a restricted area under subsection 17.14(1) is not permitted to enter a restricted area at any aerodrome in Canada for a period of 72 hours after the denial.

Record keeping — air carrier

17.16 (1) An air carrier must keep a record of the following information in respect of a person each time the person is denied permission to board an aircraft under paragraph 17.13(1)(b):

Retention

(2) The air carrier must retain the record for a period of at least 12 months after the date of the flight.

Ministerial request

(3) The air carrier must make the record available to the Minister on request.

Record keeping — screening authority

17.17 (1) A screening authority must keep a record of the following information in respect of a person each time the person is denied entry to a restricted area under subsection 17.14(1):

Retention

(2) The screening authority must retain the record for a period of at least 12 months after the day on which it was created.

Ministerial request

(3) The screening authority must make the record available to the Minister on request.

[17.18 and 17.19 reserved]

Policy Respecting Mandatory Vaccination

Application

17.20 Sections 17.21 to 17.25 apply to

Definition of relevant person

17.21 (1) For the purposes of sections 17.22 to 17.25, relevant person, in respect of an entity referred to in section 17.20, means a person whose duties involve an activity described in subsection (2) and who is

Activities

(2) For the purposes of subsection (1), the activities are

Comprehensive policy — operators of aerodromes

17.22 (1) The operator of an aerodrome must establish and implement a comprehensive policy respecting mandatory COVID-19 vaccination in accordance with subsection (2).

Policy — content

(2) The policy must

Medical contraindication

(3) For the purposes of subparagraph (2)(b)(i), the policy must provide that an exemption is to be granted to a person on the basis of a medical contraindication only if they provide a medical certificate from a medical doctor or nurse practitioner certifying that they cannot complete a COVID-19 vaccination regimen due to a medical condition and specifying whether the condition is permanent or temporary.

Religious belief

(4) For the purposes of subparagraph (2)(b)(i), the policy must provide that an exemption is to be granted to a person on the basis of their sincerely held religious belief only if they submit an attestation, sworn by them, that they have not completed a COVID-19 vaccination regimen due to their sincerely held religious beliefs.

Canadian Human Rights Act

(5) For the purposes of subparagraph (2)(b)(i), in the case of an employee of the operator of an aerodrome or a person hired by the operator of an aerodrome to provide a service, the policy must provide that an exemption is to be granted to a person on the basis of their sincerely held religious beliefs only if the operator of the aerodrome is obligated to accommodate them on the basis of this ground under the Canadian Human Rights Act by providing such an exemption.

Applicable legislation

(6) For the purposes of subparagraph (2)(b)(i), in the following cases, the policy must provide that an exemption is to be granted to a person on the basis of their sincerely held religious beliefs only if they would be entitled to such an exemption as an accommodation on the basis of this ground under applicable legislation:

Comprehensive policy — air carriers and NAV CANADA

17.23 Section 17.24 does not apply to an air carrier or NAV CANADA if that entity

Targeted policy — air carriers and NAV CANADA

17.24 (1) An air carrier or NAV CANADA must establish and implement a targeted policy respecting mandatory COVID-19 vaccination in accordance with subsection (2).

Policy — content

(2) The policy must

Medical contraindication

(3) For the purposes of subparagraph (2)(b)(i), the policy must provide that an exemption is to be granted to a relevant person on the basis of a medical contraindication only if they provide a medical certificate from a medical doctor or nurse practitioner certifying that they cannot complete a COVID-19 vaccination regimen due to a medical condition and specifying whether the condition is permanent or temporary.

Religious belief

(4) For the purposes of subparagraph (2)(b)(i), the policy must provide that an exemption is to be granted to a relevant person on the basis of their sincerely held religious belief only if they submit an attestation, sworn by them, that they have not completed a COVID-19 vaccination regimen due to their sincerely held religious beliefs.

Canadian Human Rights Act

(5) For the purposes of subparagraph (2)(b)(i), in the case of an employee of an entity or a person hired by an entity to provide a service, the policy must provide that an exemption is to be granted to a relevant person on the basis of their sincerely held religious beliefs only if the entity is obligated to accommodate the relevant person on the basis of this ground under the Canadian Human Rights Act by providing such an exemption.

Applicable legislation

(6) For the purposes of subparagraph (2)(b)(i), in the following cases, the policy must provide that an exemption is to be granted to a relevant person on the basis of their sincerely held religious beliefs only if they would be entitled to such an exemption as an accommodation on the basis of this ground under applicable legislation:

Ministerial request — policy

17.25 (1) The operator of an aerodrome, an air carrier or NAV CANADA must make a copy of the policy referred to in section 17.22, 17.23 or 17.24, as applicable, available to the Minister on request.

Ministerial request — implementation

(2) The operator of an aerodrome, an air carrier or NAV CANADA must make information related to the implementation of the policy referred to in section 17.22, 17.23 or 17.24, as applicable, available to the Minister on request.

[17.26 to 17.29 reserved]

Vaccination — Aerodromes in Canada

Application

17.30 (1) Sections 17.31 to 17.40 apply to all of the following persons:

Non-application

(2) Sections 17.31 to 17.40 do not apply to any of the following persons:

Prohibition

17.31 (1) A person must not enter a restricted area of an aerodrome unless they are a fully vaccinated person.

Exception

(2) Subsection (1) does not apply to a person who has been granted an exemption referred to in paragraph 17.22(2)(b) or 17.24(2)(b).

Provision of evidence

17.32 A person must provide to a screening authority or the operator of an aerodrome, on their request,

Request for evidence

17.33 Before permitting a certain number of persons, as specified by the Minister and selected on a random basis, to enter a restricted area, the screening authority must request that each of those persons, when they present themselves for screening at a non-passenger screening checkpoint or a passenger screening checkpoint, provide the evidence referred to in paragraph 17.32(a) or (b).

Declaration

17.34 (1) A person who is a fully vaccinated person or has been granted an exemption referred to in paragraph 17.22(2)(b) and who is unable, following a request to provide evidence under section 17.33, to provide the evidence, may

Exception

(2) Subsection (1) does not apply to the holder of a document of entitlement that expires within seven days after the day on which the request to provide evidence under section 17.33 is made.

Notification to aerodrome operator

(3) If a person signs a declaration referred to in paragraph (1)(a), the screening authority must notify the operator of the aerodrome as soon as feasible of the person’s name and the number or identifier of the person’s document of entitlement.

Provision of evidence

(4) A person who signed a declaration under paragraph (1)(a) must provide the evidence referred to in paragraph 17.32(a) or (b) to the operator of the aerodrome within seven days after the day on which the declaration is signed.

Suspension of restricted area access

(5) An operator of an aerodrome must ensure that the restricted area access of a person who does not provide the evidence within seven days as required under subsection (4) is suspended until the person provides the evidence.

Record keeping — suspension

17.35 (1) The operator of the aerodrome must keep a record of the following information in respect of a person each time the restricted area access of the person is suspended under subsection 17.34(5):

Retention

(2) The operator must retain the record for a period of at least 12 months after the day on which the record was created.

Ministerial request

(3) The operator of the aerodrome must make the record available to the Minister on request.

Prohibition

17.36 (1) A screening authority must deny entry to a restricted area if a person, following a request to provide evidence under section 17.33, does not provide the evidence or, if applicable, does not sign or provide a declaration under subsection 17.34(1).

Notification to aerodrome operator

(2) If a screening authority denies entry to a restricted area it must notify the operator of the aerodrome as soon as feasible of the person’s name and, if applicable, the number or identifier of the person’s document of entitlement.

False or misleading evidence

17.37 A person must not provide evidence that they know to be false or misleading.

Notice to Minister

17.38 A screening authority or the operator of an aerodrome that has reason to believe that a person has provided evidence that is likely to be false or misleading must notify the Minister of the person’s name and, if applicable, the number or identifier of the person’s document of entitlement no later than 72 hours after the provision of the evidence.

Record keeping — denial of entry

17.39 (1) A screening authority must keep a record of the following information in respect of a person each time the person is denied entry to a restricted area under subsection 17.36(1):

Retention

(2) The screening authority must retain the record for a period of at least 12 months after the day on which the record was created.

Ministerial request

(3) The screening authority must make the record available to the Minister on request.

Requirement to establish and implement

17.40 The operator of an aerodrome must ensure that a document of entitlement is only issued to a fully vaccinated person or a person who has been granted an exemption referred to in paragraph 17.22(2)(b).

Face Masks

Non-application

18 (1) Sections 19 to 24 do not apply to any of the following persons:

Face mask readily available

(2) An adult responsible for a child who is at least two years of age but less than six years of age must ensure that a face mask is readily available to the child before boarding an aircraft for a flight.

Wearing of face mask

(3) An adult responsible for a child must ensure that the child wears a face mask when wearing one is required under section 21 and complies with any instructions given by a gate agent under section 22 if the child

Notification

19 A private operator or air carrier must notify every person who intends to board an aircraft for a flight that the private operator or air carrier operates that the person must

Obligation to possess face mask

20 Every person who is at least six years of age must be in possession of a face mask before boarding an aircraft for a flight.

Wearing of face mask — persons

21 (1) Subject to subsections (2) and (3), a private operator or air carrier must require a person to wear a face mask at all times during the boarding process and during a flight that the private operator or air carrier operates.

Exceptions — person

(2) Subsection (1) does not apply

Exceptions — flight deck

(3) Subsection (1) does not apply to any of the following persons when they are on the flight deck:

Compliance

22 A person must comply with any instructions given by a gate agent, a member of the aerodrome security personnel or a crew member with respect to wearing a face mask.

Prohibition — private operator or air carrier

23 A private operator or air carrier must not permit a person to board an aircraft for a flight that the private operator or air carrier operates if

Refusal to comply

24 (1) If, during a flight that a private operator or air carrier operates, a person refuses to comply with an instruction given by a crew member with respect to wearing a face mask, the private operator or air carrier must

Retention period

(2) The private operator or air carrier must retain the record for a period of at least 12 months after the date of the flight.

Ministerial request

(3) The private operator or air carrier must make the record available to the Minister on request.

Wearing of face mask — crew member

25 (1) Subject to subsections (2) and (3), a private operator or air carrier must require a crew member to wear a face mask at all times during the boarding process and during a flight that the private operator or air carrier operates.

Exceptions — crew member

(2) Subsection (1) does not apply

Exception — flight deck

(3) Subsection (1) does not apply to a crew member who is a flight crew member when they are on the flight deck.

Wearing of face mask — gate agent

26 (1) Subject to subsections (2) and (3), a private operator or air carrier must require a gate agent to wear a face mask during the boarding process for a flight that the private operator or air carrier operates.

Exceptions

(2) Subsection (1) does not apply

Exception — physical barrier

(3) During the boarding process, subsection (1) does not apply to a gate agent if the gate agent is separated from any other person by a physical barrier that allows the gate agent and the other person to interact and reduces the risk of exposure to COVID-19.

Deplaning

Non-application

27 (1) Section 28 does not apply to any of the following persons:

Wearing of face mask

(2) An adult responsible for a child must ensure that the child wears a face mask when wearing one is required under section 28 if the child

Wearing of face mask — person

28 A person who is on board an aircraft must wear a face mask at all times from the moment the doors of the aircraft are opened until the person enters the air terminal building, including by a passenger loading bridge.

Screening Authority

Non-application

29 (1) Sections 30 to 33 do not apply to any of the following persons:

Wearing of face mask

(2) An adult responsible for a child must ensure that the child wears a face mask when wearing one is required under subsection 30(2) and removes it when required by a screening officer to do so under subsection 30(3) if the child

Requirement — passenger screening checkpoint

30 (1) A screening authority must notify a person who is subject to screening at a passenger screening checkpoint that they must wear a face mask at all times during screening.

Wearing of face mask — person

(2) Subject to subsection (3), a person who is the subject of screening referred to in subsection (1) must wear a face mask at all times during screening.

Requirement to remove face mask

(3) A person who is required by a screening officer to remove their face mask during screening must do so.

Wearing of face mask — screening officer

(4) A screening officer must wear a face mask at a passenger screening checkpoint when conducting the screening of a person if, during the screening, the screening officer is two metres or less from the person being screened.

Requirement — non-passenger screening checkpoint

31 (1) A person who presents themselves at a non-passenger screening checkpoint to enter into a restricted area must wear a face mask at all times.

Wearing of face mask — screening officer

(2) Subject to subsection (3), a screening officer must wear a face mask at all times at a non-passenger screening checkpoint.

Exceptions

(3) Subsection (2) does not apply

Exception — physical barrier

32 Sections 30 and 31 do not apply to a person, including a screening officer, if the person is two metres or less from another person and both persons are separated by a physical barrier that allows them to interact and reduces the risk of exposure to COVID-19.

Prohibition — passenger screening checkpoint

33 (1) A screening authority must not permit a person who has been notified to wear a face mask and refuses to do so to pass beyond a passenger screening checkpoint into a restricted area.

Prohibition — non-passenger screening checkpoint

(2) A screening authority must not permit a person who refuses to wear a face mask to pass beyond a non-passenger screening checkpoint into a restricted area.

Designated Provisions

Designation

34 (1) The provisions of this Interim Order set out in column 1 of Schedule 4 are designated as provisions the contravention of which may be dealt with under and in accordance with the procedure set out in sections 7.7 to 8.2 of the Act.

Maximum amounts

(2) The amounts set out in column 2 of Schedule 4 are the maximum amounts of the penalty payable in respect of a contravention of the designated provisions set out in column 1.

Notice

(3) A notice referred to in subsection 7.7(1) of the Act must be in writing and must specify

Repeal

35 The Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 44, made on November 10, 2021, is repealed.

SCHEDULE 1

(Subsection 13(2))

Countries and Territories
Item Name
1 India
2 Morocco

SCHEDULE 2

(Subsections 1(1) and 17.1(1) and paragraphs 17.1(2)(c), 17.20(a) and (b), 17.21(2)(d) and 17.30(1)(a) to (c) and (e))

Aerodromes
Name ICAO Location Indicator
Abbotsford International CYXX
Alma CYTF
Bagotville CYBG
Baie-Comeau CYBC
Bathurst CZBF
Brandon Municipal CYBR
Calgary International CYYC
Campbell River CYBL
Castlegar (West Kootenay Regional) CYCG
Charlo CYCL
Charlottetown CYYG
Chibougamau/Chapais CYMT
Churchill Falls CZUM
Comox CYQQ
Cranbrook (Canadian Rockies International) CYXC
Dawson Creek CYDQ
Deer Lake CYDF
Edmonton International CYEG
Fort McMurray CYMM
Fort St. John CYXJ
Fredericton International CYFC
Gander International CYQX
Gaspé CYGP
Goose Bay CYYR
Grande Prairie CYQU
Greater Moncton International CYQM
Halifax (Robert L. Stanfield International) CYHZ
Hamilton (John C. Munro International) CYHM
Îles-de-la-Madeleine CYGR
Iqaluit CYFB
Kamloops CYKA
Kelowna CYLW
Kingston CYGK
Kitchener/Waterloo Regional CYKF
La Grande Rivière CYGL
Lethbridge CYQL
Lloydminster CYLL
London CYXU
Lourdes-de-Blanc-Sablon CYBX
Medicine Hat CYXH
Mont-Joli CYYY
Montréal (Montréal — Pierre Elliott Trudeau International) CYUL
Nanaimo CYCD
North Bay CYYB
Ottawa (Macdonald-Cartier International) CYOW
Penticton CYYF
Prince Albert (Glass Field) CYPA
Prince George CYXS
Prince Rupert CYPR
Québec (Jean Lesage International) CYQB
Quesnel CYQZ
Red Deer Regional CYQF
Regina International CYQR
Rivière-Rouge/Mont-Tremblant International CYFJ
Rouyn-Noranda CYUY
Saint John CYSJ
Sarnia (Chris Hadfield) CYZR
Saskatoon (John G. Diefenbaker International) CYXE
Sault Ste. Marie CYAM
Sept-Îles CYZV
Smithers CYYD
St. Anthony CYAY
St. John’s International CYYT
Stephenville CYJT
Sudbury CYSB
Sydney (J.A. Douglas McCurdy) CYQY
Terrace CYXT
Thompson CYTH
Thunder Bay CYQT
Timmins (Victor M. Power) CYTS
Toronto (Billy Bishop Toronto City) CYTZ
Toronto (Lester B. Pearson International) CYYZ
Toronto/Buttonville Municipal CYKZ
Val-d’Or CYVO
Vancouver International CYVR
Victoria International CYYJ
Wabush CYWK
Whitehorse (Erik Nielsen International) CYXY
Williams Lake CYWL
Windsor CYQG
Winnipeg (James Armstrong Richardson International) CYWG
Yellowknife CYZF

SCHEDULE 3

(Subparagraph 17.22(2)(a)(iii) and paragraphs 17.24(2)(a) and 17.30(2)(e))

Departments and Departmental Corporations
Name
Canada Border Services Agency
Correctional Service of Canada
Department of Agriculture and Agri-Food
Department of Fisheries and Oceans
Department of Health
Department of the Environment
Department of Transport
Public Health Agency of Canada
Royal Canadian Mounted Police

SCHEDULE 4

(Subsections 34(1) and (2))

Designated Provisions

Column 1

Designated Provision

Column 2

Maximum Amount of Penalty ($)
Individual Corporation
Subsection 2(1) 5,000 25,000
Subsection 2(2) 5,000 25,000
Subsection 2(3) 5,000 25,000
Subsection 2(4) 5,000 25,000
Subsection 3(1) 5,000  
Subsection 3(2) 5,000  
Section 4 5,000 25,000
Section 5 5,000 25,000
Subsection 8(1) 5,000 25,000
Subsection 8(2) 5,000 25,000
Subsection 8(3) 5,000  
Subsection 8(4) 5,000 25,000
Subsection 8(5) 5,000  
Subsection 8(7) 5,000 25,000
Section 9 5,000 25,000
Section 10 5,000  
Section 12 5,000 25,000
Subsection 13(1) 5,000  
Section 15 5,000  
Section 16 5,000 25,000
Section 17 5,000 25,000
Section 17.2   25,000
Subsection 17.3(1) 5,000  
Subsection 17.4(1) 5,000  
Subsection 17.5(1)   25,000
Subsection 17.5(2)   25,000
Section 17.6   25,000
Section 17.7 5,000  
Section 17.11 5,000  
Section 17.12   25,000
Subsection 17.13(1)   25,000
Subsection 17.13(2)   25,000
Subsection 17.14(1)   25,000
Subsection 17.14(2)   25,000
Subsection 17.14(3)   25,000
Subsection 17.14(4)   25,000
Subsection 17.15(1) 5,000  
Subsection 17.15(2) 5,000  
Subsection 17.16(1)   25,000
Subsection 17.16(2)   25,000
Subsection 17.16(3)   25,000
Subsection 17.17(1)   25,000
Subsection 17.17(2)   25,000
Subsection 17.17(3)   25,000
Subsection 17.22(1)   25,000
Subsection 17.24(1)   25,000
Subsection 17.25(1)   25,000
Subsection 17.25(2)   25,000
Subsection 17.31(1) 5,000  
Section 17.32 5,000  
Section 17.33   25,000
Subsection 17.34(3)   25,000
Subsection 17.34(4) 5,000  
Subsection 17.34(5)   25,000
Subsection 17.35(1)   25,000
Subsection 17.35(2)   25,000
Subsection 17.35(3)   25,000
Subsection 17.36(1)   25,000
Subsection 17.36(2)   25,000
Section 17.37 5,000  
Section 17.38   25,000
Subsection 17.39(1)   25,000
Subsection 17.39(2)   25,000
Subsection 17.39(3)   25,000
Section 17.40   25,000
Subsection 18(2) 5,000  
Subsection 18(3) 5,000  
Section 19 5,000 25,000
Section 20 5,000  
Subsection 21(1) 5,000 25,000
Section 22 5,000  
Section 23 5,000 25,000
Subsection 24(1) 5,000 25,000
Subsection 24(2) 5,000 25,000
Subsection 24(3) 5,000 25,000
Subsection 25(1) 5,000 25,000
Subsection 26(1) 5,000 25,000
Subsection 27(2) 5,000  
Section 28 5,000  
Subsection 29(2) 5,000  
Subsection 30(1)   25,000
Subsection 30(2) 5,000  
Subsection 30(3) 5,000  
Subsection 30(4) 5,000  
Subsection 31(1) 5,000  
Subsection 31(2) 5,000  
Subsection 33(1)   25,000
Subsection 33(2)   25,000

DEPARTMENT OF TRANSPORT

CANADA SHIPPING ACT, 2001

Interim Order Respecting Certain Flooded Areas in British Columbia, 2021, No. 2

Whereas the Minister of Transport is of the opinion that the annexed Interim Order Respecting Certain Flooded Areas in British Columbia, 2021, No. 2 is required to deal with a direct or indirect risk to marine safety or to the marine environment;

And whereas the provisions of the annexed Order may be contained in a regulation made pursuant to paragraphs 136(1)(f)footnote h and (h)footnote h of the Canada Shipping Act, 2001footnote i;

Therefore, the Minister of Transport, pursuant to subsection 10.1(1)footnote j of the Canada Shipping Act, 2001 footnote i, makes the annexed Interim Order Respecting Certain Flooded Areas in British Columbia, 2021, No. 2.

Ottawa, November 30, 2021

Omar Alghabra
Minister of Transport

Interim Order Respecting Certain Flooded Areas in British Columbia, 2021, No. 2

Interpretation

Interpretation

1 Unless the context requires otherwise, words and expressions used in this Interim Order have the same meaning as in the Vessel Operation Restriction Regulations.

Prohibition

Operation of vessels

2 It is prohibited for a person to operate a vessel in the waters mentioned in column 2 of the table to this section, that are in the vicinity of a location set out in column 1 and that are within the areas illustrated on a map, entitled Map relating to the Transport Canada Interim Order Respecting Certain Flooded Areas in British Columbia, 2021, published on November 30, 2021, by the Department of Transport and available through its website.

TABLE
Item

Column 1

Location

Column 2

Waters
1 City of Merritt
  • Coldwater River and waters over the floodplains within the limits of the city of Merritt
  • Coldwater River and its tributaries, south of the city of Merritt, and waters over the floodplains along Coldwater Road near its intersection with Kane Valley Road
2 City of Princeton Similkameen River within the limits of the city of Princeton and waters over the floodplains to the east of that city
3 Regional District of the Okanagan - Similkameen Similkameen River and waters over the floodplains along Crowsnest Highway, from south of Hedley to the U.S. border
4 City of Abbotsford/ City of Chilliwack
  • Sumas River and the waters over the floodplains on the Sumas Prairies, between McCallum Road, the U.S. border and Vedder River
  • Fraser River and its tributaries, including the waters over the neighbouring floodplains, from the town of Yale to the city of Mission
  • Chilliwack River and the waters over the floodplains from Chilliwack Lake to, and including, Vedder River, and also including Slesse Creek
5 District of Hope Coquihalla River and the waters over the floodplains along the Coquihalla Highway and Crowsnest Highway from Shylock Road to where the Coquihalla River meets the Fraser River
6 Village of Lytton Fraser River and its tributaries, including waters over the neighbouring floodplains, from south of the community of Lillooet to south of the village of Lytton
7 Village of Tulameen Tulameen River and the waters over the floodplains in the vicinity of the village of Tulameen
8 Nicola River Nicola River and the waters over the floodplains from the community of Spences Bridge to Spius Creek, west of the city of Merritt

Exception

Persons

3 Section 2 does not apply to vessels operated by any of the following persons:

Enforcement

Enforcement officers

4 For the purpose of ensuring compliance with section 2, the persons or classes of persons set out in the table to this section are appointed or specified as enforcement officers.

TABLE
Item

Column 1

Person or Class of Persons

Column 2

Geographic Location
1 A member of the Royal Canadian Mounted Police Across Canada
2 An officer of the Canadian Coast Guard who is a Marine Communications and Traffic Services Officer Across Canada
3 An officer of the Canadian Coast Guard working on a vessel, when they are on board the vessel Across Canada
4 A member of any harbour or river police force Across Canada
5 A member of any provincial, county or municipal police force British Columbia
6 A marine safety inspector Across Canada
7 A pleasure craft safety inspector Across Canada
8 A First Nations Constable appointed under the British Columbia Police Act, R.S.B.C. 1996, c. 367 British Columbia
9 A fishery officer designated under the Fisheries Act Across Canada
10 An Office of Boating Safety Officer Across Canada

Powers

5 An enforcement officer may

Repeal

6 The Interim Order Respecting Certain Flooded Areas in British Columbia, 2021, made on November 19, 2021, is repealed.

DEPARTMENT OF TRANSPORT

CANADA SHIPPING ACT, 2001

Interim Order Respecting Vessel Restrictions and Vaccination Requirements Due to the Coronavirus Disease 2019 (COVID-19)

Whereas the Minister of Transport believes that the annexed Interim Order Respecting Vessel Restrictions and Vaccination Requirements Due to the Coronavirus Disease 2019 (COVID-19) is required to deal with a direct or indirect risk to marine safety or to the marine environment;

And whereas the provisions of the annexed Interim Order may be contained in a regulation made pursuant to subsection 120(1)footnote k and paragraphs 136(1)(f)footnote h and (h)footnote i of the Canada Shipping Act, 2001footnote i;

Therefore, the Minister of Transport, pursuant to subsection 10.1(1)footnote j of the Canada Shipping Act, 2001 footnote j, makes the annexed Interim Order Respecting Vessel Restrictions and Vaccination Requirements Due to the Coronavirus Disease 2019 (COVID-19).

Ottawa, November 29, 2021

Omar Alghabra
Minister of Transport

Interim Order Respecting Vessel Restrictions and Vaccination Requirements Due to the Coronavirus Disease 2019 (COVID-19)

Interpretation

Definitions

1 (1) The following definitions apply in this Interim Order.

COVID-19
means the coronavirus disease 2019. (COVID-19)
COVID-19 molecular test
means a COVID-19 screening or diagnostic test carried out by an accredited laboratory, including a test performed using the method of polymerase chain reaction (PCR) or reverse transcription loop-mediated isothermal amplification (RT-LAMP). (essai moléculaire relatif à la COVID-19)
cruise ship
means any passenger vessel, other than a ferry vessel or a passenger vessel that provides essential services, whose passengers are scheduled to be on board for 24 hours or more. (navire de croisière)
ferry vessel
means any vessel, having provision for deck passengers and for vehicles, that is operated on a short run on a schedule between two points over the most direct water route and offers a public service of a type normally attributed to a bridge or tunnel. (transbordeur)
Minister
means the Minister of Transport. (ministre)
passenger vessel
means a vessel, other than a ferry vessel, that is certified to carry more than 12 passengers as indicated on its inspection certificate or Passenger Ship Safety Certificate issued under the Vessel Safety Certificates Regulations or on an equivalent certificate issued by a foreign government. (bâtiment à passagers)
passenger vessel that provides essential services
means a passenger vessel that is set out in the schedule. (bâtiment à passagers qui fournit des services essentiels)
pilot
has the same meaning as in section 1.1 of the Pilotage Act. (pilote)
Ship Safety Bulletin No. 17/2021
means the Ship Safety Bulletin entitled Measures for Persons (other than passengers) on Canadian Vessels and Foreign Passenger Vessels Operating in Canadian Waters to Mitigate the Spread of COVID-19, SSB No. 17/2021, published on November 1, 2021 by the Marine Safety and Security Directorate of Transport Canada, as amended from time to time or as replaced. (bulletin de la sécurité des navires no 17/2021)
Ship Safety Bulletin No. 18/2021
means the Ship Safety Bulletin entitled Measures to Support Safe Cruise Travel in Canada, SSB No. 18/2021, published on November 30, 2021 by the Marine Safety and Security Directorate of Transport Canada, as amended from time to time or as replaced. (bulletin de la sécurité des navires no 18/2021)

Interpretation — fully vaccinated

(2) For the purposes of this Interim Order, a person is fully vaccinated at least 14 days after the they complete a COVID-19 vaccine dosage regimen if

For greater certainty

(3) For greater certainty, for the purposes of subsection (2), a COVID-19 vaccine that is authorized for sale in Canada does not include a similar vaccine sold by the same manufacturer that has been authorized for sale in another jurisdiction.

Application

Passengers

2 The provisions of this Interim Order apply in respect of passengers beginning on November 30, 2021.

Canadian Vessels

Prohibition

3 (1) It is prohibited for a Canadian vessel, other than a cruise ship, that is operated with 12 or more crew members on board to be operated in any waters, unless the vessel’s authorized representative

Prohibition — other vessels

(2) Subsection (1) also applies in respect of any other Canadian vessel, other than a cruise ship, of an authorized representative who is also the authorized representative of a cruise ship that is a Canadian vessel or of any other Canadian vessel that is operated with 12 or more crew members on board.

Exception

(3) For the purposes of paragraph (1)(b), the reference to “person” does not include

Evidence of vaccination

4 (1) It is prohibited for a person, other than a person who intends to be a passenger or who is a pilot, to board a Canadian vessel referred to in section 3 that is in Canadian waters unless the person provides to the vessel’s authorized representative

Verification

(2) Despite subsection (1), a person, other than a person who intends to be a passenger or who is a pilot, may board the vessel if the authorized representative has verified that the person has not completed a COVID-19 vaccine dosage regimen due to one of the following reasons:

Evidence

(3) A person who relies on a reason referred to in paragraph (2)(a) or (b) must provide to the authorized representative evidence of their medical contraindication or their sincerely held religious belief that contains the information set out in Ship Safety Bulletin No. 17/2021.

COVID-19 test result

(4) Before boarding a vessel, a person who is not fully vaccinated, other than a person who intends to be a passenger or who is a pilot, must provide to the vessel’s authorized representative evidence that they received

Prohibition

(5) A person who is not fully vaccinated, other than a person who intends to be a passenger or who is a pilot, who receives a positive result for a COVID-19 test must not board the vessel for a period of 14 days after the the specimen on which the test was performed was collected, unless they receive a negative result for a COVID-19 molecular test that was performed on a specimen collected from the person no more than 72 hours before the person boards the vessel.

Evidence — elements

(6) For the purposes of this Interim Order, evidence of a result for a COVID-19 test must include

Continued testing

(7) Any person who provides evidence of a result described in paragraph (4)(a) must be tested for COVID-19 in accordance with the authorized representative’s vaccination policy every three days for the duration of the voyage if it is scheduled to last six days or more.

Pilots

Prohibition

5 (1) It is prohibited for any vessel that is operated in Canadian waters to have a pilot on board unless the vessel’s authorized representative verifies

Verification

(2) Despite subsection (1), a vessel referred to in that subsection that is operated in Canadian waters may have on board a pilot who is not fully vaccinated if the vessel’s authorized representative verifies that the pilot has a document confirming that the pilotage authority that employs the pilot or that has a contract with the pilot or with a body corporate of which the pilot is a member or shareholder has verified that the pilot has provided evidence that they have not completed a COVID-19 vaccine dosage regimen for a reason referred to in subsection 6(2).

Prohibition

6 (1) It is prohibited for a pilot to board any vessel that is operated in Canadian waters unless the pilot provides to the vessel’s authorized representative

Verification

(2) Despite subsection (1), a pilot referred to in that subsection may board the vessel if the pilotage authority that employs the pilot or that has a contract with the pilot or with a body corporate of which the pilot is a member or shareholder has verified that the pilot has not completed a COVID-19 vaccine dosage regimen due to one of the following reasons:

Accommodation under applicable legislation

(3) If a pilot relies on a reason referred to in subsection (2), the pilotage authority that employs the pilot or that has a contract with the pilot or with a body corporate of which the pilot is a member or shareholder must verify that the pilot is entitled to be accommodated, on the basis of the reason the pilot is relying on, under applicable legislation by being permitted to board the cruise ship without being fully vaccinated.

Evidence

(4) A pilot who relies on a reason referred to in paragraph (2)(a) or (b) must provide to the pilotage authority evidence of their medical contraindication or their sincerely held religious belief that contains the information set out in Ship Safety Bulletin No. 17/2021.

COVID-19 test result

(5) Before boarding a vessel, a pilot who is not fully vaccinated must provide to the vessel’s authorized representative evidence that they have received a result described in subsection 4(4) for a COVID-19 test that they took or a result described in subsection 4(5) for a COVID-19 molecular test that they took, as the case may be.

Cruise Ships

Prohibition

7 (1) It is prohibited for a cruise ship that is a Canadian vessel to be operated in any waters, and for a cruise ship that is a foreign vessel to be operated in Canadian waters, unless the cruise ship’s authorized representative

Vaccination status

(2) For the purposes of paragraph (1)(b), the vaccination status to be verified is the following:

Exception

(3) For the purposes of paragraph (1)(b), the reasons a person may have for not being vaccinated are the following:

COVID-19 test results

(4) For the purposes of paragraph (1)(c), the COVID-19 test results that a person must have received are the following:

Confirmation

8 Before a cruise ship is operated in Canadian waters, the authorized representative of the cruise ship must confirm to the Minister that they have

Evidence of vaccination

9 (1) It is prohibited for any person, other than a passenger or pilot, to be on board a cruise ship that is a Canadian vessel or a cruise ship that is a foreign vessel in Canadian waters unless the person has provided to the cruise ship’s authorized representative

Evidence of vaccination — passengers

(2) It is prohibited for a passenger who is 12 years and 4 months of age or older to be on board a cruise ship that is a Canadian vessel or a cruise ship that is a foreign vessel in Canadian waters unless they have provided to the cruise ship’s authorized representative evidence of COVID-19 vaccination demonstrating that they are fully vaccinated.

Verification

(3) Despite subsection (1) and paragraph (2)(a), a person may board the cruise ship if the authorized representative has verified that the person has not completed a COVID-19 vaccine dosage regimen due to one of the following reasons:

Accommodation under applicable legislation

(4) If the person relying on a reason referred to in subsection (3) is a passenger, the authorized representative must verify that the passenger is entitled to be accommodated, on the basis of the reason they are relying on, under applicable legislation by being permitted to board the cruise ship without being fully vaccinated.

Evidence

(5) A person who relies on a reason referred to in paragraph (3)(a) or (b) must provide to the authorized representative the following evidence:

COVID-19 test results — persons other than passengers

(6) A person who is not fully vaccinated, other than a passenger or pilot, must have provided to the cruise ship’s authorized representative evidence that they received their results of a COVID-19 test referred to in subsection 4(4) or (5).

Continued testing

(7) Any person, other than a passenger or pilot, who provides evidence of a result described in paragraph 4(4)(a) for a COVID-19 test that they took or a result described in subsection 4(5) for a COVID-19 molecular test that they took, as the case may be, must be tested for COVID-19 in accordance with the authorized representative’s vaccination policy every three days for the duration of the voyage if that voyage is scheduled to last six days or more.

COVID-19 test results — passengers

(8) A person who intends to be a passenger must be tested for COVID-19 in accordance with Ship Safety Bulletin No. 18/2021 and must provide the results of their COVID-19 test to the authorized representative in accordance with that Bulletin.

Notification — vaccination

10 A cruise ship that is a foreign vessel on a voyage to Canada departing from any other country must not enter Canadian waters unless the authorized representative of the cruise ship notified every person before they boarded the cruise ship that they may be required, under an order made under section 58 of the Quarantine Act, to provide, before boarding the cruise ship or before entering Canadian waters, to the Minister of Health or to a screening officer, as defined in section 2 of that Act, or person designated as a quarantine officer under subsection 5(2) of that Act, by the electronic means specified by that Minister, information related to their COVID-19 vaccination and evidence of COVID-19 vaccination. The authorized representative must also notify every person that they may be denied permission to board the cruise ship and may be liable to a fine if this requirement applies to them and they fail to comply with it.

Exceptions

11 Sections 3 to 10 do not apply to

Vaccination Policy

Content

12 (1) A vaccination policy must include

Medical contraindication

(2) For the purposes of paragraphs (1)(g) and (h), the vaccination policy must provide that a document is to be issued to a person confirming that they did not complete a COVID-19 vaccine dosage regimen on the basis of a medical contraindication only if the person provides a medical certificate from a medical doctor or nurse practitioner who is licensed to practise in Canada certifying that the person cannot complete a COVID-19 vaccination regimen due to a medical condition and specifying whether the condition is permanent or temporary.

Canadian Human Rights Act

(3) For the purposes of paragraphs (1)(g) and (h), in the case of an employee of an authorized representative or a person hired by the authorized representative to provide a service, the vaccination policy must provide that a document is to be issued to the employee or person confirming that they did not complete a COVID-19 vaccine dosage regimen on the basis of their sincerely held religious beliefs only if the authorized representative is obligated to accommodate them on that basis under the Canadian Human Rights Act.

Applicable legislation

(4) For the purposes of paragraphs (1)(g) and (h), in the case of an employee of an authorized representative’s contractor or agent or mandatary, the vaccination policy must provide that a document is to be issued to the employee confirming that they did not complete a COVID-19 vaccine dosage regimen on the basis of their sincerely held religious beliefs only if they would be entitled to an accommodation on that basis under applicable legislation.

Vaccination policy kept on board

(5) The authorized representative of a vessel referred to in section 3 or of a cruise ship that is a Canadian vessel must ensure that a copy of the vaccination policy is kept on board each such vessel or cruise ship of which they are the authorized representative and must make that policy available to the Minister within 48 hours of the Minister’s request.

Familiarity with policy

(6) The authorized representative must ensure that the crew members on board the vessel or cruise ship are familiar with the content of the vaccination policy and must keep on board the vessel or cruise ship a record indicating that the crew members have familiarized themselves with the policy.

Authorized representative’s confirmation

13 The authorized representative of a vessel referred to in section 3 or of a cruise ship that is a Canadian vessel that begins to operate after this Interim Order is made must, on the day on which the vessel or cruise ship begins to operate, provide to the Minister written confirmation that they implemented a vaccination policy that meets the requirements set out in subsection 12(1).

Documents

14 The authorized representative of a vessel referred to in section 3 or of a cruise ship that is a Canadian vessel must make information related to the implementation of the vaccination policy available to the Minister on the Minister’s request.

Amending vaccination policy

15 The authorized representative of a vessel referred to in section 3 or of a cruise ship that is a Canadian vessel must amend the vaccination policy on the request of the Minister and must submit the amended vaccination policy to the Minister within five business days after the day on which the request is made.

Evidence of vaccination — elements

16 (1) For the purposes of this Interim Order, evidence of COVID-19 vaccination must be evidence issued by the government or the non-governmental entity that is authorized to issue it and must contain the following information:

Evidence of vaccination — translation

(2) The evidence of COVID-19 vaccination must be in English or French and any translation into English or French must be a certified translation.

Notice to Minister — persons other than passengers

17 (1) An authorized representative referred to in section 3 or 7 or a pilotage authority referred to in subsection 6(2) who has reason to believe that a person other than a passenger provided evidence of COVID-19 vaccination, of a COVID-19 test result, of a medical contraindication or of a sincerely held religious belief that is likely to be false or misleading must as soon as feasible provide to the Minister the person’s name, contact information and, if applicable, their Candidate document number (CDN) or their Certificate of Competency number from the Standards for Training, Certification and Watchkeeping (STCW).

Notice to Minister — passengers

(2) An authorized representative of a cruise ship who has reason to believe that a passenger provided evidence of COVID-19 vaccination, of a COVID-19 test result, of a medical contraindication or of a sincerely held religious belief that is likely to be false or misleading must as soon as feasible provide to the Minister

COVID-19 Management Plan

Content

18 A COVID-19 management plan must include

Notice to Minister

19 The authorized representative of a cruise ship must notify the Minister 45 days before the cruise ship is first operated in, or first enters, Canadian waters, whichever occurs first after this Interim Order is made, that they have implemented their COVID-19 management plan in accordance with section 18.

Management plan kept on board

20 The authorized representative of a cruise ship that is a Canadian vessel operating in any waters or of a cruise ship that is a foreign vessel operating in Canadian waters must ensure that a copy of their COVID-19 management plan is kept on board each cruise ship of which they are the authorized representative and must make that plan available to the Minister within 48 hours of the Minister’s request.

Amending management plan

21 The authorized representative of a cruise ship must amend their COVID-19 management plan on the request of the Minister and must submit the amended plan to the Minister within five business days after the the request is made.

Checklist Respecting Procedures at Ports

Requirement

22 (1) The authorized representative of a cruise ship must have a checklist respecting procedures to be followed at the ports where the cruise ship is scheduled to call that is signed by the port authorities of those ports and the appropriate public health authorities.

Content

(2) The checklist must include

Notice to Minister

(3) The authorized representative of a cruise ship must notify the Minister 45 days before the cruise ship is first operated in, or first enters, Canadian waters, whichever occurs first after this Interim Order is made, that they have the checklist referred to in subsection (1).

Checklist kept on board

23 The authorized representative of a cruise ship that is a Canadian vessel operating in any waters or of a cruise ship that is a foreign vessel operated in Canadian waters must ensure that a copy of the checklist referred to in subsection 22(1) is kept on board each cruise ship of which they are the authorized representative and must make that checklist available to the Minister within 48 hours of the Minister’s request.

Reports

Complete report

24 (1) The authorized representative of a vessel referred to in section 3 or of a cruise ship that is a Canadian vessel must provide to the Minister, in accordance with Ship Safety Bulletin No. 17/2021, a report that contains the following information:

Abridged report

(2) An authorized representative of a vessel referred to in section 3 or of cruise ship that is a Canadian vessel who implements a vaccination policy that exceeds the requirements of this Interim Order and that applies to all their employees, including those whose employment responsibilities do not require them to be on board the vessel or cruise ship, is exempt from subsection (1) but must provide to the Minister, in accordance with Ship Safety Bulletin No. 17/2021, a report that contains the information set out in paragraphs (1)(a) to (d).

Report on passengers

25 An authorized representative of a cruise ship that is a Canadian vessel operating in any waters or of a cruise ship that is a foreign vessel operating in Canadian waters must provide to the Minister, in accordance with Ship Safety Bulletin No. 18/2021, a report that contains the following information:

Passenger Vessels That Provide Essential Services and Ferry Vessels

Permission

26 (1) A passenger vessel that provides essential services may be operated in Canadian waters if

Notice to Minister

(2) The authorized representative of a vessel who implements measures in accordance with paragraph (1)(b) must notify the Minister, in writing, of the measures before implementing them and must keep a copy of the notice on board.

Guidelines

27 The authorized representative and master of a passenger vessel that provides essential services must make reasonable efforts to implement the measures contained in the guidelines that are set out in the document entitled COVID-19: Guidance Material for Passenger Vessel and Ferry Operators published on April 17, 2020 by the Marine Safety and Security Directorate of Transport Canada, as amended from time to time.

Ferry vessels

28 The authorized representative and master of a ferry vessel must ensure that the applicable requirements set out in section 3, paragraph 26(1)(a) or (b) and subsection 26(2) are met and must comply with the requirement set out in section 27.

Prohibition — Authorized Representative and Master

Prohibition

29 The authorized representative, and master, of a vessel referred to in section 3 or a cruise ship must not permit the vessel or cruise ship to contravene any of the restrictions or prohibitions set out in this Interim Order.

Enforcement

Persons ensuring compliance

30 (1) The following persons are authorized to ensure compliance with this Interim Order:

Powers and duties

(2) A person who is authorized to ensure compliance with this Interim Order may

Obligation to comply

31 A person or vessel must comply with any direction given to them or a requirement or prohibition imposed on them under subsection 30(2).

Repeal

32 The Interim Order No. 7 Respecting Passenger Vessel Restrictions Due to the Coronavirus Disease 2019 (COVID-19), made on October 30, 2021, is repealed.

SCHEDULE

(Subsection 1(1))

Passenger Vessels That Provide Essential Services
Item Vessels
1 A vessel operating to protect public health or safety or the marine environment including a vessel that is involved in
  • (a) search and rescue operations; or
  • (b) emergency or environmental response.
2 A vessel that supports the activities of any of the following at their request:
  • (a) the Minister;
  • (b) the Minister of Fisheries and Oceans;
  • (c) a member of the Canadian Coast Guard; or
  • (d) a peace officer in the performance of their duties.
3 A vessel that operates when it is the most practical means to
  • (a) give passengers access to their domicile or residence or their place of employment;
  • (b) give passengers access to essential goods and services, including
    • (i) goods or services directly related to the response to COVID-19, including medical equipment, testing and laboratory services,
    • (ii) essential health services, including primary health care services and pharmacies, and
    • (iii) food, potable water, pharmaceuticals and fuel;
  • (c) transport cargo to resupply communities, businesses or industry; or
  • (d) give passengers access to services that are declared to be essential services by the Government of Canada, a provincial government, a local authority or a government, council or other entity authorized to act on behalf of an Indigenous group.

PRIVY COUNCIL OFFICE

Appointment opportunities

We know that our country is stronger — and our government more effective — when decision-makers reflect Canada’s diversity. The Government of Canada has implemented an appointment process that is transparent and merit-based, strives for gender parity, and ensures that Indigenous peoples and minority groups are properly represented in positions of leadership. We continue to search for Canadians who reflect the values that we all embrace: inclusion, honesty, fiscal prudence, and generosity of spirit. Together, we will build a government as diverse as Canada.

We are equally committed to providing a healthy workplace that supports one’s dignity, self-esteem and the ability to work to one’s full potential. With this in mind, all appointees will be expected to take steps to promote and maintain a healthy, respectful and harassment-free work environment.

The Government of Canada is currently seeking applications from diverse and talented Canadians from across the country who are interested in the following positions.

Current opportunities

The following opportunities for appointments to Governor in Council positions are currently open for applications. Every opportunity is open for a minimum of two weeks from the date of posting on the Governor in Council appointments website.

Governor in Council appointment opportunities
Position Organization Closing date
Chief Executive Officer Canadian Centre on Substance Abuse  
Member Canadian Cultural Property Export Review Board  
Chief Executive Officer Canadian Dairy Commission  
Deputy Chief Commissioner Canadian Human Rights Commission  
Member Canadian Human Rights Commission  
Member Canadian Museum of Nature  
Chairperson Invest in Canada Hub  
Chief Executive Officer Invest in Canada Hub  
Director Invest in Canada Hub  
Trustee National Gallery of Canada  
Privacy Commissioner Office of the Privacy Commissioner of Canada  
Director (Federal) Québec Port Authority  
Director Windsor-Detroit Bridge Authority