Canada Gazette, Part I, Volume 154, Number 40: GOVERNMENT NOTICES

October 3, 2020

DEPARTMENT OF EMPLOYMENT AND SOCIAL DEVELOPMENT

EMPLOYMENT INSURANCE ACT
EMPLOYMENT INSURANCE REGULATIONS

Resolution

Pursuant to section 66.5 of the Employment Insurance Act, notice is hereby given that the employment insurance premium rate for the year 2021 is $1.58 per $100 of insurable earnings.

Pursuant to sections 76.07 and 76.35 of the Employment Insurance Regulations, notice is hereby given that the employment insurance premium reduction rate for the year 2021 for residents of Quebec covered under the Quebec Parental Insurance Plan is $0.40. Therefore, the employment insurance premium rate for residents of Quebec is $1.18 per $100 of insurable earnings.

Canada Employment Insurance Commission

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;

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; and

Whereas a waiver may be granted by the Minister of the Environment under subsection 106(8) of the Canadian Environmental Protection Act, 1999 if

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.

Pascal Roberge
Acting Executive Director
Program Development and Engagement Division

On behalf of the Minister of the Environment

ANNEX

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
Aspire Health Science

Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed

Data from a test 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
AstraZeneca Canada Inc.

Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed (3) table a1 note 1

Data from a test to determine the effects of the living organism on terrestrial plant, invertebrate, and vertebrate species likely to be exposed (3)

Data from tests of antibiotic susceptibility (3)
CanSino Biologics Inc. Data from tests of antibiotic susceptibility
CARsgen Therapeutics Corporation

Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed

Data from a test to determine the effects of the living organism on terrestrial plant and invertebrate species likely to be exposed

Data from tests of antibiotic susceptibility
CRISPR Therapeutics AG

Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed

Data from a test 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
Fisher Clinical Services

Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed

Data from a test 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
Glaxosmithkline Inc.

Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed (2)

Data from a test 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)
Janssen Inc.

Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed

Data from a test 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
Merck Canada Inc.

Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed

Data from a test 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
Novartis Pharmaceuticals Canada Inc.

Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed

Data from a test 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
Ottawa Hospital Research Institute

Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed

Data from a test 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
Replimune Inc.

Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed

Data from a test to determine the effects of the living organism on terrestrial plant, invertebrate, and vertebrate species likely to be exposed
SQZ Biotechnologies

Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed

Data from a test to determine the effects of the living organism on terrestrial plant and invertebrate species likely to be exposed

Data from tests of antibiotic susceptibility
Symvivo Corporation

Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed

Data from a test to determine the effects of the living organism on terrestrial plant, invertebrate, and vertebrate species likely to be exposed
TAG Sexing Technologies ULC Data from a test to determine the ecological effects of the living organism (pathogenicity, toxicity or invasiveness)
University Health Network

Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed

Data from a test 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

Table a1 note 1

The number in parentheses 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, an average of 500 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;

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; and

Whereas a waiver may be granted by the Minister of the Environment under subsection 81(8) of the Canadian Environmental Protection Act, 1999 if

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.

Pascal Roberge
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
Afton Chemical Canada Corporation

Data in respect of adsorption-desorption screening test

Data in respect of octanol/water partition coefficient (3) table a2 note 1
Allnex Canada Inc. (Quebec)

Data in respect of ready biodegradation

Data in respect of vapour pressure
BASF Canada Inc.

Data in respect of boiling point

Data in respect of hydrolysis rate as a function of pH

Data in respect of octanol/water partition coefficient

Data in respect of ready biodegradation

Data in respect of vapour pressure (2)
Biosynthetic Technologies

Data from an in vivo mammalian test for chromosomal aberrations or gene mutations

Data in respect of hydrolysis rate as a function of pH

Data in respect of water solubility
Chevron Oronite LLC

Data in respect of hydrolysis rate as a function of pH

Data in respect of water solubility
Evonik Corporation Data from an in vivo mammalian test for chromosomal aberrations or gene mutations
Henkel Canada Corp.

Data in respect of octanol/water partition coefficient

Data in respect of water solubility
HLS Therapeutics Inc. Data from an acute mammalian toxicity test (oral, dermal or inhalation)
Infineum USA LP Data in respect of octanol/water partition coefficient
Lubrizol Canada Limited

Data from a 28-day minimum repeated-dose toxicity test (oral, dermal or inhalation)

Data from a skin irritation test

Data from a skin sensitization test

Data from an in vitro mutagenicity test for chromosomal aberrations in mammalian cells

Data from an in vivo mammalian test for chromosomal aberrations or gene mutations
Neste US, Inc.

Data from an in vivo mammalian test for chromosomal aberrations or gene mutations (2)

Data in respect of hydrolysis rate as a function of pH
Phoslock Canada Inc.

Data from an in vitro mutagenicity test for chromosomal aberrations in mammalian cells

Data from an in vitro mutagenicity test for gene mutations

Data in respect of hydrolysis rate as a function of pH

Data in respect of octanol/water partition coefficient

Data in respect of ready biodegradation

Data in respect of vapour pressure
Quadra Chemicals Ltd.

Data from an acute mammalian toxicity test (oral, dermal or inhalation)

Data from an in vitro mutagenicity test for chromosomal aberrations in mammalian cells
Shell Canada Limited Data in respect of hydrolysis rate as a function of pH

Table a2 note

Table a2 note 1

The number in parentheses 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, an average of 500 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
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication after screening assessment of four substances in the Other Polymers Group specified on the Domestic Substances List (subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas the four substances identified in the annex below are substances identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the draft screening assessment conducted on these substances pursuant to section 74 of the Act is annexed hereby;

And whereas it is proposed to conclude that DGEBA-DA resin, soya alkyd resin and polyurethane-33 do not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Minister of the Environment and the Minister of Health (the ministers) propose to take no further action on these substances at this time under section 77 of the Act.

And whereas it is proposed to conclude that PHMB meets one or more of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the ministers propose to recommend to Her Excellency the Governor in Council that PHMB be added to Schedule 1 of the Act.

Notice is furthermore given that the ministers have released a risk management scope document for PHMB to initiate discussions with stakeholders on the development of risk management actions.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Canada.ca (Chemical Substances) website. All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be addressed to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819‑938‑5212, by email to eccc.substances.eccc@ canada.ca, or by using the online reporting system available through Environment and Climate Change Canada’s Single Window.

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

Jacqueline Gonçalves
Director General
Science and Risk Assessment Directorate
On behalf of the Minister of the Environment

Gwen Goodier
Director General
Industrial Sectors, Chemicals and Waste Directorate
On behalf of the Minister of the Environment

Greg Carreau
Acting Director General
Safe Environments Directorate
On behalf of the Minister of Health

ANNEX

Summary of the draft screening assessment of the Other Polymers Group

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of Environment and the Minister of Health have conducted a screening assessment of four substances referred to collectively under the Chemicals Management Plan as the Other Polymers Group. Substances in this group were identified as priorities for assessment as they met categorization criteria under subsection 73(1) of CEPA. The Chemical Abstracts Service Registry Numbers (CAS RNsfootnote 1), the Domestic Substances List (DSL) names and the abbreviations of these substances are listed in the table below.

Substances in the Other Polymers Group
CAS RN DSL name Abbreviations
55818-57-0 Phenol, 4,4’-(1-methylethylidene)bis-, polymer with (chloromethyl) oxirane, 2-propenoate DGEBA-DA resin
32289-58-0 27083-27-8 table a3 note a

Poly(iminocarbonimidoylim inocarbonimidoylimino-1,6- hexanediyl), hydrochloride

Guanidine, N,N’’’-1,6-hexanediylbis[N’- cyano-, polymer with 1,6-hexanediamine, hydrochloride

 PHMB
67762-15-6 Soybean oil, polymer with maleic anhydride, pentaerythritol and phthalic anhydride Soya alkyd resin
125826-44-0 Hexanedioic acid, polymer with 2,2-dimethyl-1,3-propanediol, 1,6-hexanediol, hydrazine, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid and 1,1’-methylenebis[4-isocyanatocyclohexane], compd. with N,N-diethylethanamine Polyurethane-33

Table a3 note

Table a3 note a

The substance bearing this CAS RN was previously assessed under the Second Phase of Polymer Rapid Screening, but it is being reassessed as it is equivalent to the substance bearing CAS RN 32289-58-0.

Return to table a3 note a referrer

These four substances were previously evaluated under the Second Phase of Polymer Rapid Screening, which identified DGEBA-DA resin, PHMB (CAS RNs 32289-58-0 and 27083-27-8), soya alkyd resin, and polyurethane-33 as having low potential to cause ecological harm. However, they were identified on the basis of structural alerts, toxicological information and/or uses associated with significant consumer exposure as requiring further assessment due to potential human health risk. The present assessment further elaborates on the potential for DGEBA-DA resin, PHMB (CAS RNs 32289-58-0 and 27083-27-8), soya alkyd resin, and polyurethane-33 to cause harm to human health in order to reach an overall conclusion under section 64 of CEPA.

While conducting this assessment, it was determined that CAS RN 27083-27-8 is synonymous with CAS RN 32289-58-0; the former is described by the starting monomers, and the latter is described by the resulting polymer. As a result, the two CAS RNs can be used interchangeably. Although it had been determined that CAS RN 27083-27-8 did not meet the criteria under section 64 of CEPA during the second phase of polymer rapid screening, this CAS RN is being reassessed in this report. It is additionally noted that PHMB may also be identified by two other CAS RNs (28757-47-3 and 1802181-67-4) outside of Canada; these additional CAS RNs are not on the Domestic Substances List and would be subject to notification and assessment under the New Substances Notification Regulations (Chemicals and Polymers) prior to being imported or manufactured in Canada.

DGEBA-DA resin, PHMB (CAS RNs 32289-58-0 and 27083-27-8), soya alkyd resin, and polyurethane-33 were identified in the second phase of polymer rapid screening (ECCC, HC 2018) as having either low water solubility/extractability or low potential for exposure and were characterized as having low potential for ecological risk.

DGEBA-DA resin does not occur naturally in the environment. In Canada, it is reported to be used as a binder, sealant, and reactive oligomer in the coating, automotive and adhesive industries, as well as in printing inks and overprint varnishes, packaging (including food packaging materials), books, newsprint, cosmetics, toners, and colourants. It has been reported that between 100 000 and 1 000 000 kg of DGEBA-DA resin were either manufactured in or imported into Canada in 2014. Although DGEBA-DA resin contains acrylates (a reactive functional group [RFG] associated with adverse human health effects), almost all DGEBA-DA resin in commercial and consumer applications is present in its cured form, lacking the free acrylates present in the monomers and any other RFGs or structural features associated with human health concerns. Acrylate groups present in the uncured substance are associated with dermal sensitization, subchronic toxicity with effects on the prostate, and genotoxicity. However, a negligible amount of unreacted material is expected to be present in the cured DGEBA-DA resins. Neither direct exposure (oral, inhalation, dermal) nor indirect exposure of the general population to DGEBA-DA resin through residues in drinking water is expected.

PHMB does not occur naturally in the environment. In Canada, it is reported to be used as an antimicrobial preservative in cosmetics and pharmaceuticals. It has been reported that the substance is not manufactured in Canada, but that between 100 and 1 000 kg of PHMB were imported into Canada in 2014. In Canada, direct exposure (oral, dermal, inhalation) of the general population to PHMB is expected. The greatest risk is associated with inhalation exposure. On April 7, 2017, the European Commission’s Scientific Committee on Consumer Safety (SCCS) adopted the opinion that the use of PHMB as a preservative in cosmetic products at concentrations up to 0.1% is safe but that its use in sprayable formulations is not advised. PHMB has high inhalation toxicity, and Commission Regulation (EU) 2019/831 states that PHMB should not be used in applications that may lead to exposure of the end user’s lungs by inhalation (EU 2019). Cosmetic products containing PHMB can be purchased by Canadians. The International Nomenclature of Cosmetic Ingredients (INCI) database identifies CAS RN 32289-58-0 under the INCI name of “polyaminopropyl biguanide,” and the Cosmetics Notification Database has added 282 cosmetic notifications containing this substance since 2015. The majority of these products list this substance at less than 0.1%, but a small number of products show concentrations of up to 3%. Considering a concentration of 0.1% PHMB in a cosmetic spray product, margins of exposure (MOEs) of 22.7 and 7.4 for adults and children, respectively, were estimated. The calculated MOEs for cosmetic spray products are considered inadequate to address uncertainties in the health effects and exposure databases. PHMB is listed as a non-medicinal ingredient (NMI) in the Natural Health Products Ingredients Database. It can be used as a preservative antimicrobial, for topical use only, up to 0.1% and is not permitted in sprayable formulations. Indirect exposure of the general population to PHMB through environmental residues in drinking water is not anticipated. PHMB causes adverse effects on the respiratory system. It is also a dermal sensitizer with three known cases of anaphylaxis. Cross sensitization from respiratory exposure is not known. Therefore, the dermal sensitization potential to PHMB remains a health risk to members of the general population, in addition to posing inhalation hazard concerns.

On the basis of further evaluation, soya alkyd resin and polyurethane-33 were identified as meeting the criteria used to identify polymers of low concern of the New Substances Notification Regulations (Chemicals and Polymers). Both of these substances are used in coatings, such as paints. Polymers of low concern are generally of low ecological and human health hazard. It is therefore proposed to conclude that these two polymers are not a concern to the environment or human health.

Considering all available lines of evidence presented in this assessment, there is a low risk of harm to the environment from DGEBA-DA resin, PHMB (CAS RNs 32289-58-0 and 27083-27-8), soya alkyd resin, and polyurethane-33. It is proposed to conclude that these substances do not meet the criteria under paragraph 64(a) or (b) of CEPA as they are not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

Based on the information presented in this draft screening assessment, it is proposed to conclude that DGEBA-DA resin, soya alkyd resin, and polyurethane-33 do not meet the criteria under paragraph 64(c) of CEPA as they are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger to human life or health in Canada. However, it is proposed to conclude that PHMB (CAS RNs 32289-58-0 and 27083-27-8) meets the criteria under paragraph 64(c) of CEPA as it is entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Proposed overall conclusion

Therefore, it is proposed to conclude that DGEBA-DA resin, soya alkyd resin, and polyurethane-33 do not meet any of the criteria set out in section 64 of CEPA, but that PHMB (CAS RNs 32289-58-0 and 27083-27-8) does meet the criteria in section 64 of CEPA.

It is also proposed that PHMB (CAS RNs 32289-58-0 and 27083-27-8) meets the persistence criteria but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA.

The draft screening assessment and the risk management scope document for these substances are available on the Canada.ca (Chemical Substances) website.

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19

Whereas the Minister of Health believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment;

Therefore, the Minister of Health, pursuant to subsection 30.1(1)footnote a of the Food and Drugs Actfootnote b, makes the annexed Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.

Ottawa, September 16, 2020

Patricia Hajdu
Minister of Health

Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19

Interpretation

Definitions

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

Other words and expressions

(2) Unless the context otherwise requires, words and expressions used in this Interim Order have the meanings assigned by the Regulations.

Interpretation

(3) For the purposes of the definition innovative drug in subsection C.08.004.1(1) of the Regulations, a medicinal ingredient in a COVID-19 drug is not considered to be approved in a drug by the Minister by reason of the Minister having issued or amended an authorization in respect of the COVID-19 drug.

Authorizations

Non-application

2 (1) The provisions of the Regulations — other than the following provisions — do not apply to a COVID-19 drug if an authorization is issued in respect of the drug and the authorization is not suspended or revoked:

Clarification

(2) For greater certainty, an authorization issued in respect of a COVID-19 drug authorizes the sale and advertising of the drug in accordance with this Interim Order.

Application for authorization

3 (1) Subject to section 4, an application for an authorization in respect of a COVID-19 drug must be in a form established by the Minister and contain sufficient information and material to enable the Minister to determine whether to issue the authorization, including

Incomplete application — plan

(2) If, at the time an application is initially submitted to the Minister, the applicant is unable to provide information or material referred to in any of paragraphs (1)(g) to (k) and (m) to (o) or that information or material is incomplete, the applicant must include in the initial part of the application a plan as to how and when they will provide the Minister with the missing information or material.

Application based on comparison

(3) A person may submit an application for an authorization in respect of a COVID-19 drug under this section on the basis of a direct or indirect comparison to another drug only if

Application for authorization — foreign drug

4 (1) An application for an authorization in respect of a COVID-19 drug may be based on a comparison to a foreign drug if the sale of the foreign drug is authorized by a foreign regulatory authority on the basis of information submitted to the authority in relation to the quality, safety and effectiveness of that drug.

Content

(2) The application must be in a form established by the Minister and contain the following information and material:

Issuance

5 The Minister must issue an authorization in respect of a COVID-19 drug if the following requirements are met:

Prohibition — significant difference

6 (1) It is prohibited to sell a COVID-19 drug to which an authorization relates if any of the matters referred to in subsection 3(1) or subsection 4(2) — other than in paragraph 3(1)(i) or 4(2)(e), as the case may be — are significantly different from the information or material contained in the application, unless the Minister amends the authorization.

Amendment

(2) The Minister must amend the authorization if the following requirements are met:

Drug identification number

7 (1) When the Minister issues or amends an authorization, he or she must assign a drug identification number for each distinct combination of dosage form, strength and route of administration for the COVID-19 drug to which the authorization relates.

Deeming — holder

(2) Any reference to a person that holds a drug identification number in sections C.01.050, C.01.052, C.01.053 and C.01A.003 of the Regulations is deemed to include a reference to the holder of an authorization.

Deeming — drug identification number

(3) Any reference to a drug identification number in the provisions of Divisions 1 and 1A of Part C of the Regulations — other than in sections C.01.050, C.01.052, C.01.053 and C.01A.003 — is deemed to include a reference to a drug identification number assigned under subsection (1).

Notification of first sale

8 The holder of an authorization must, within 15 days after the day on which the COVID-19 drug to which the authorization relates is first sold in Canada, notify the Minister, in writing, of the date of that first sale.

Notification of discontinuance

9 The holder of an authorization must, within 15 days after the day on which they permanently discontinue the sale in Canada of the COVID-19 drug to which the authorization relates, notify the Minister, in writing, of the date on which the sale was permanently discontinued.

Terms and conditions

10 The Minister may, at any time, impose terms and conditions on an authorization or amend those terms and conditions.

Suspension

11 (1) The Minister may suspend an authorization, in whole or in part, giving reasons, if

Reinstatement

(2) The Minister must reinstate a suspended authorization if the holder provides to the Minister, in the time, form and manner specified by the Minister, information or material that demonstrates that the situation giving rise to the suspension did not exist or has been corrected.

Discretionary revocation

12 (1) The Minister may revoke an authorization, in whole or in part, giving reasons, if the holder of the authorization has not provided to the Minister, in the time, form and manner specified by the Minister, the information or material referred to in subsection 11(2).

Mandatory revocation

(2) The Minister must revoke an authorization if the holder of the authorization requests it.

Request for information or material

13 (1) The Minister may request that a person that has submitted an application for an authorization in respect of a COVID-19 drug or the holder of such an authorization provide any information or material, including samples, that is necessary to enable the Minister to determine whether to issue, amend or suspend the authorization.

Time, form and manner

(2) The person or holder, as the case may be, must provide the information, material or samples in the time, form and manner specified by the Minister.

Comparison — submission or supplement

14 (1) Despite sections C.08.002, C.08.002.01, C.08.002.1 and C.08.003 of the Regulations and subject to subsection (2), a manufacturer of a new drug is not permitted to file a submission or supplement for the new drug on the basis of a direct or indirect comparison to a COVID-19 drug in respect of which an authorization is issued.

Clarification

(2) In the case where both a notice of compliance and an authorization are issued in respect of a COVID-19 drug, subsection (1) does not prevent a manufacturer of a new drug from filing a submission or supplement for the new drug in respect of the matters that are approved under the notice of compliance.

Expanded indication

15 Section C.08.003 of the Regulations does not apply to the sale of a new drug — in respect of which a notice of compliance is issued and that is set out in the List of New Drugs for Expanded Indication — in relation to the expanded indication that is set out in the List in respect of the new drug if the Minister

Supplementary information

16 The Minister must publish on a Government of Canada website supplementary information pertaining to the expanded indication of a new drug that is set out in the List of New Drugs for Expanded Indication, including

Information request

17 (1) If a new drug for which a notice of compliance is issued is set out in the List of New Drugs for Expanded Indication, the Minister may request the manufacturer to which the notice of compliance is issued to provide any information that it possesses or has reasonable access to in relation to the expanded indication that is set out in the List in respect of the drug.

Time, form and manner

(2) The manufacturer must provide the information in the time, form and manner specified by the Minister.

Shortages or discontinuation of sale

18 Despite the definition drug in section C.01.014.8 of the Regulations, sections C.01.014.9 and C.01.014.10 of the Regulations apply, with any modifications that may be necessary, to the holder of an authorization in respect of the COVID-19 drug to which the authorization relates.

Records

19 (1) The holder of an authorization must maintain records of the following in relation to the COVID-19 drug to which the authorization relates:

Provision to Minister

(2) The holder of the authorization must provide to the Minister

Establishment Licences

Application for establishment licence

20 (1) A person that submits an application for an establishment licence under section C.01A.005 of the Regulations that relates solely to one or more activities set out in Table I of section C.01A.008 of the Regulations in respect of a COVID-19 drug may include a statement to that effect in the application.

Application for amendment

(2) A person that submits an application for the amendment of their establishment licence under section C.01A.006 of the Regulations that relates solely to one or more activities set out in Table I of section C.01A.008 of the Regulations in respect of a COVID-19 drug may include a statement to that effect in the application.

Deeming

(3) In the case of an application referred to in subsection (1) or (2) that includes the relevant statement, any reference to information and documents in sections C.01A.006 and C.01A.008 of the Regulations is deemed to include that statement.

Information and material

21 For the purposes of section C.01A.008 of the Regulations, the Minister must, in determining whether he or she has received the information and material required by sections C.01A.005 to C.01A.007 of the Regulations in relation to an application referred to in subsection 20(1) or (2) that includes the statement referred to in the applicable subsection, also take into consideration the necessity of addressing the urgent public health need related to COVID-19.

Terms and conditions

22 (1) Despite subsection C.01A.008(4) of the Regulations and subject to subsection (2), the Minister may, at any time, including when issuing an establishment licence, impose terms and conditions on an establishment licence that is issued or amended under section C.01A.008 of the Regulations on the basis of an application referred to in subsection 20(1) or (2) that includes the statement referred to in the applicable subsection.

Duration

(2) Any terms and conditions that the Minister imposes on an establishment licence under subsection (1) cease to apply to the licence immediately before this Interim Order ceases to have effect.

Scope

(3) For greater certainty, terms and conditions that may be imposed under subsection (1) are not limited to those described in paragraphs C.01A.008(4)(a) and (b) of the Regulations.

Amending terms and conditions

23 Despite section C.01A.012 of the Regulations, the Minister may, at any time, amend any terms and conditions that are imposed on an establishment licence under section 22.

Verification — holder or importer

24 (1) If the holder of an authorization receives a lot or batch of the COVID-19 drug to which the authorization relates — or an importer receives a lot or batch of such a COVID-19 drug — on their premises in Canada the useful life of which is more than 30 days, the holder or importer must visually inspect the lot or batch to confirm its identity.

Verification — packager/labeller

(2) If a packager/labeller receives a lot or batch of a COVID-19 drug on their premises in Canada the useful life of which is more than 30 days, the packager/labeller must test the lot or batch for identity and must confirm the identity of the lot or batch after it is packaged/labelled.

Exception — holder

(3) Subsection (1) does not apply to the holder of the authorization if the COVID-19 drug is fabricated, packaged/labelled and tested in Canada by a person that holds an establishment licence that authorizes those activities in respect of that drug.

Exception — holder or importer

(4) Subsection (1) does not apply to the holder of the authorization or the importer if the following requirements are met:

Non-application — records

25 (1) Paragraphs C.02.020(1)(a), (b) and (d) of the Regulations do not apply to an importer in respect of a COVID-19 drug to which an authorization relates.

Deeming — holder

(2) Any reference in section C.02.020 of the Regulations to a distributor referred to in paragraph C.01A.003(b) of the Regulations is deemed to include a reference to the holder of an authorization.

Cancellation

26 (1) Any establishment licence that the Minister has issued under section C.01A.008 of the Regulations on the basis of an application referred to in subsection 20(1) that includes the statement referred to in that subsection is cancelled immediately before this Interim Order ceases to have effect.

Amendment ceasing to have effect

(2) Any amendment that the Minister has made to an establishment licence that was issued under section C.01A.008 of the Regulations before this Interim Order is made ceases to have effect immediately before this Interim Order ceases to have effect if the Minister made the amendment on the basis of an application referred to in subsection 20(2) that included the statement referred to in that subsection.

Pre-positioning of COVID-19 Drugs

Application

27 Sections 28 to 30 apply in respect of a COVID-19 drug if the following conditions are met:

Importation

28 (1) The holder of an establishment licence may import a COVID-19 drug if the following conditions are met:

Exception

(2) Paragraph (1)(b) does not apply to the holder of an establishment licence in respect of a building referred to in subparagraph (1)(b)(i) if

Letter

(3) If the conditions set out in subsection (1) are met, the Minister must send a letter to the Chief Public Health Officer to that effect.

Non-application — importation

29 Sections A.01.040 and C.01.004.1, subsection C.01A.004(1) and section C.01A.006 of the Regulations and the provisions of Divisions 2 to 4 of Part C of the Regulations, except for the following provisions, do not apply in respect of the importation of a COVID-19 drug by the holder of an establishment licence under section 28:

Distribution of imported drug

30 Despite anything in the Regulations, the holder of an establishment licence may distribute a COVID-19 drug that they have imported under section 28 if the following conditions are met:

EXPLANATORY NOTE

(This note is not part of the Interim Order.)

Proposal

The Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the Interim Order) was signed by the Minister of Health on September 16, 2020. The Interim Order allows for the issuance of an expedited authorization for the importation, sale and advertising of drugs used in relation to COVID-19; this includes both human and veterinary drugs. It allows the Minister to account for urgent public health needs relating to COVID-19 in deciding whether to authorize a COVID-19 drug based on the provided evidence of safety, efficacy, and quality. The Interim Order also allows establishment licences to be issued in relation to COVID-19 drugs in a more agile manner, taking into consideration urgent public health needs, and provides a mechanism for the Minister to allow the Public Health Agency of Canada (PHAC) to import promising COVID-19 drugs for placement (pre-positioning) in Canadian facilities prior to their authorization in Canada.

The Interim Order was made under subsection 30.1(1) of the Food and Drugs Act (the Act), which allows the Minister to make temporary interim orders if the Minister believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment.

Without an Order in Council approving it, the Interim Order would, in accordance with paragraph 30.1(2)(a) of the Act, cease to have effect 14 days after it was made. An Order in Council would enable the operation of the Interim Order, allowing it to remain in effect for up to one year after it is made.

Objective

The objective of the Interim Order is to expedite the authorization for the importation, sale, and advertising of drugs used in relation to COVID-19 while taking into consideration urgent public health needs. It also provides an option for establishment licences to be issued in relation to COVID-19 drugs in a more agile manner. The Interim Order further provides the ability for the Chief Public Health Officer of PHAC to notify the Minister of a need to pre-position a promising COVID-19 drug in Canada. In order for a drug to be pre-positioned, the Government of Canada must have entered into a contract for its procurement and the manufacturer must have filed an application for the drug’s authorization in Canada, or abroad with a foreign reference regulator. Together, these measures help ensure Canadians have timely access to COVID-19 drugs.

Background

COVID-19 is a new disease not previously identified in humans. It is an infectious respiratory disease caused by the most recently discovered coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). COVID-19 infection has been known to cause respiratory symptoms, fever, cough, shortness of breath, and breathing difficulties. In more severe cases, it may cause pneumonia, severe acute respiratory syndrome, kidney failure, and death. The World Health Organization declared a global pandemic related to COVID-19 on March 11, 2020. There are now more than 26 300 000 cases, in at least 185 countries, and over 860 000 people have lost their lives.footnote 2 The number of confirmed cases in Canada as of September 3, 2020, has exceeded 130 000;footnote 3 however, the situation is changing rapidly.

Many pharmaceutical companies and academic institutions worldwide are developing candidate vaccines and potential treatments and therapies for COVID-19. While these new drugs and vaccines are being developed to specifically address COVID-19, pharmaceutical companies are looking at the potential of using already approved and marketed drugs, such as broad-spectrum antivirals and anti-inflammatory drugs. Expedited authorization of drugs for use in relation to COVID-19 will allow these medically necessary drugs to be made available quickly for Canadians.

Prior to a product being available on the Canadian market, Health Canada reviews product information to confirm the requirements of the Food and Drugs Act and its associated regulations are met. Based on the information provided, the Department assesses the risks and benefits of the product to ensure Canadians have access to products that are safe, effective and of high quality. In addition, any person who fabricates, packages, labels, imports, tests, distributes, or wholesales a drug for sale in Canada must hold an establishment licence issued under the Food and Drug Regulations.

On March 18, 2020, the Minister of Health published a notice entitled “Expedited Review of Health Product Submissions and Applications to address COVID-19.” This notice outlined Health Canada’s intent to expedite the authorization of a vaccine and other therapies for COVID-19 as they become available.

Implications

The Interim Order introduces expedited authorization pathways for the importation, sale and advertising of drugs used in relation to COVID-19. The authorization of a drug under the Interim Order is predicated on the Minister’s determination that the evidence provided supports the conclusion that the benefits outweigh the risks associated with the drug, taking into account the uncertainties related to the benefits and risks, as well as the urgent public health need caused by COVID-19. This includes weighing the risks of modifying certain requirements for information to support the safety and effectiveness of a drug, such as allowing consideration of a foreign regulatory approval, against the benefits of having it available to Canadians quickly.

The Interim Order introduces expedited authorization pathways for drugs with a COVID-19 indication that are not yet authorized in Canada or other jurisdictions, as well as COVID-19 drugs that are authorized for sale by a foreign regulatory authority. In addition, the Interim Order provides a mechanism to permit the sale of a drug that is already authorized in Canada under this Interim Order or the Food and Drug Regulations, for indications related to COVID-19 that are not included in the drug’s authorization.

Although COVID-19 is understood to be primarily a human disease, COVID-19 is a new disease and its impacts on animal health may not be fully known at this time. To date, there have not been any reports of livestock contracting COVID-19 and early information from a small number of studies suggests pigs, chickens and ducks are not susceptible to the virus. However, there have been several reports of infected humans spreading the virus to their pet dog or cat; therefore, out of an abundance of caution, veterinary drugs were included in the scope of the Interim Order.

Drugs not authorized in Canada or by a foreign regulatory authority

The Interim Order introduces an expedited pathway for the authorization of a new COVID-19 drug by providing more agile application and administrative requirements than what is offered under division 8 of the Food and Drug Regulations.

The Interim Order provides the Minister with the ability to take into consideration the uncertainties and the urgent public health needs in the context of the COVID-19 pandemic while determining if a drug demonstrates that its benefits outweigh its risks. Instead of providing detailed reports of the tests establishing the safety of a new drug and substantial evidence of clinical effectiveness as required by the Food and Drug Regulations, the Interim Order requires an applicant to submit the known information with respect to the safety and effectiveness of a COVID-19 drug.

In addition, in order to expedite the review process for drug applications submitted for authorization under the Interim Order, a more agile approach has been included to allow an applicant to file further information throughout the course of the review as it becomes available, also known as a rolling application. If using this rolling application approach, the applicant must submit a plan outlining how and when they will provide the Minister with the required information or data that is outstanding.

Drugs authorized by a foreign regulatory authority

In order for a drug to be eligible to use the expedited pathway for drugs that are authorized by a foreign regulatory authority, the drug must be included on the List of Foreign Drugs, which is maintained by the Minister and incorporated by reference in the Interim Order. A drug may be included on this list if it has been shown to provide benefit in the context of the COVID-19 pandemic, and it has received an authorization for sale in a foreign jurisdiction. The Minister may become aware of such drugs through interactions with international counterparts or environmental scanning, including dialogues with health care providers or potential drug applicants.

In order to be imported, sold, or advertised in Canada, a drug included on the list must still be authorized under the Interim Order; however, the applicant can leverage this foreign regulatory approval and submit a more abbreviated application. The applicant must submit evidence that the drug is authorized for sale in a foreign jurisdiction and sign an attestation that, if requested, all of the information used to authorize the drug by the foreign regulatory authority will be made available to the Minister.

With respect to the foreign drug, the Minister must still determine that all criteria outlined in the Interim Order have been met and, in the context of the COVID-19 pandemic, the benefits of authorizing this drug outweigh the risks.

Expanded indication of drugs authorized in Canada

The Interim Order permits a drug that is already authorized in Canada to be advertised and sold for an expanded indication related to COVID-19. This will be done by the addition of the drug to the incorporated by reference List of New Drugs for Expanded Indication. Unlike for an amendment under the Food and Drug Regulations, this process can be initiated without an application from the manufacturer.

Additions to this list will be based on environmental scanning by Health Canada, including dialogues with health care providers, as evidence supporting the use of existing drugs in the context of COVID-19 becomes available. However, an external applicant may make the Minister aware of a drug that may qualify for this process.

As a drug qualifying for this process will already hold an authorization through the Interim Order or the Food and Drug Regulations, there will already be known evidence to support its safety, efficacy (for other indications) and quality. In addition, the inclusion of a drug to this list will allow the Minister to request any information the authorization holder may have pertaining to the COVID-19 indication. Any additional information provided on the COVID-19-related indication is also included on the incorporated by reference list.

Drug establishment licences and good manufacturing practices

The Interim Order introduces an option for drug establishment licences to be issued or amended to include the conduct of activities in relation to COVID-19 drugs. This balances the need for flexibilities, such as the modification of certain good manufacturing practices requirements, while still protecting the health and safety of Canadians who will use these COVID-19 drugs. All drug establishment licence applications submitted in relation to the Interim Order will be processed in an expedited manner. Licensing decisions will consider both the material submitted in the application and the necessity of the drug in addressing urgent COVID-19-related health needs.

Labelling, advertising, and reporting requirements

In order to maintain bilingual labelling requirements in accordance with the Official Languages Act, the Interim Order ensures the appropriate sections of the Food and Drug Regulations will still apply to COVID-19 drugs. These drugs are also subject to similar advertising prohibitions, as well as adverse drug reaction reporting and recall and shortages reporting requirements, as drugs authorized under the Food and Drug Regulations.

Terms and conditions

The Interim Order allows the Minister to impose or amend terms and conditions, and request additional information, in relation to a COVID-19 drug submission, authorization, or establishment licence, at any time while it is in effect. In light of the severity of the COVID-19 pandemic, this allows the Minister to act quickly to gather important safety information or mitigate risk in a timely manner.

Suspension or cancellation

When expediting the authorization of a drug in relation to COVID-19 through the Interim Order, with the goal of enabling timely access to drugs in relation to COVID-19, Health Canada will continue to ensure that these products are supported by sufficient evidence of safety, efficacy and quality. Health Canada will monitor the safety and effectiveness of these drugs and will take immediate action, including the suspension or cancellation of authorizations or establishment licences, if required, to protect the health and safety of Canadians.

Intellectual property

The Interim Order does not include explicit intellectual property protections for innovative drugs submitted for authorization through this process. However, Health Canada will ensure that an innovative drug is able to receive data protection, if and when an authorization is issued under the Food and Drug Regulations or another transitional mechanism, by ensuring an authorization for a drug and its medicinal ingredients issued under the Interim Order is not considered a previous approval for the purposes of defining an innovative drug under section C.08.004.1 of the Food and Drug Regulations; and stipulating that a submission cannot be made under the Food and Drug Regulations for a new drug, in respect of a COVID-19 claim, based on a direct or indirect comparison to a COVID-19 drug authorized under the Interim Order.

In addition, to maintain incentives for manufacturers of COVID-19 drugs and to ensure the accessibility of these drugs, an application for an authorization based on the direct or indirect comparison to another COVID-19 drug will only be accepted if that other drug is not available on the Canadian market in sufficient quantities to address urgent public health needs related to COVID-19. Prior to a person submitting an application based on a direct or indirect comparison to another drug, they must notify the Minister of their intent to file and provide information demonstrating that the drug being compared to has been issued an authorization under the Interim Order or a Notice of Compliance and is not available in sufficient quantities. The Minister is then required to notify the manufacturer of the drug it is being compared to so the manufacturer can make representations to the Minister as to whether or not it is available in sufficient quantities. If the Minister determines that the drug being compared to is not available in sufficient quantities, the application can be submitted.

Authorization period and fees

Authorizations issued under, and drug establishment licences issued in relation to, the Interim Order are only valid while the Interim Order is in effect. The review of drug applications submitted under the Interim Order will not be subject to cost recovery fees, nor will fees be charged for establishment licence applications submitted in relation to the Interim Order if the application meets the conditions specified in the Establishment Licence Fees Remission Order (Indication of an activity in respect of a COVID-19 Drug). In addition, the annual fee to sell a product on the Canadian market will not apply to COVID-19 drugs.

Release of clinical information

Health Canada will make publicly available the safety and efficacy evidence relied upon to issue an authorization under the Interim Order. Clinical information will be released for non-commercial purposes and will have all personal information and confidential business information protected prior to publication on Health Canada’s Clinical Information Portal.

Pre-positioning

In order to facilitate timely access to promising COVID-19 drugs, the Interim Order introduces a mechanism for the Minister to allow the importation of promising COVID-19 drugs for placement in Canadian facilities prior to their market authorization in Canada, referred to as pre-positioning. This mechanism may be used to import a promising COVID-19 drug into Canada if the Chief Public Health Officer of Canada has notified the Minister of a need to pre-position a COVID-19 drug and the Government of Canada has a procurement agreement for the purchase of the drug. In addition, the manufacturer of the drug must have filed an application for market authorization with Health Canada under the Interim Order or the Food and Drug Regulations, or filed an application for market authorization with a foreign regulatory authority.

The Chief Public Health Officer of Canada must also provide a description of the drug to be pre-positioned, which includes the quantity of the drug to be imported into Canada, information regarding the drug’s manufacturer, the proposed Canadian drug establishment licence holder that will import and pre-position the drug, and the facilities where the drug is to be stored. This establishment licence holder could be PHAC, which operates the National Emergency Stockpile System (NESS); the manufacturer itself, which has the contractual agreement with the Government of Canada; or an establishment licence holder identified by the Chief Public Health Officer of Canada.

Guidance and resources

The guidance document entitled “Information and Application Requirements for Drugs Authorized Under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19” outlines the regulatory requirements and other important information for manufacturers wishing to submit an application for authorization through the Interim Order. In addition, Health Canada will publish a list of COVID-19 drug applications received and a list of COVID-19 drugs authorized under the Interim Order. These lists, along with the List of Foreign Drugs and the List of New Drugs for Expanded Indication, will be made publicly available on the Government of Canada website.

Consultation

Canadians have been informed of the expedited review of COVID-19 drug submissions and applications through the Notice entitled “Expedited Review of Health Product Submissions and Applications to address COVID-19,” published on March 18, 2020. Through various other communications, members of the federal health portfolio, provincial and territorial governments, industry associations, and other stakeholders have been made aware, and are supportive of this action to expedite the authorization of COVID-19 drugs.

Three engagement sessions with health care system partners took place between April 30 and May 15, 2020. Stakeholders invited included hospital associations, national advisory committees, the Pan-Canadian Pharmaceutical Alliance, and provincial and territorial drug plan managers, among others. An information session with industry and industry association stakeholders was held on June 25, 2020, with over 80 participants attending, including BIOTECanada and Innovative Medicines Canada. Additional targeted sessions were held on July 2, 2020, to engage the Canadian Animal Health Institute, and July 24 and August 11, 2020, to engage innovative drug manufacturers. The intent of these sessions was to inform these key stakeholders about the details of the Interim Order, to identify measures to ensure its efficient implementation, to discuss future transition measures under consideration for when the Interim Order ceases to have effect, and to provide stakeholders with an opportunity to ask questions.

Participants of all sessions were generally supportive of the Interim Order and the proposed measures. Innovative drug manufacturers, however, raised concerns regarding the absence of protections for innovative products and intellectual property and proposed changes to alleviate these concerns. Health Canada subsequently modified the Interim Order based on these suggestions.

Contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Address Locator: 3000A
Holland Cross, Suite 14
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Email: hc.lrm.consultations-mlr.sc@canada.ca

DEPARTMENT OF PUBLIC SAFETY AND EMERGENCY PREPAREDNESS

TIME LIMITS AND OTHER PERIODS ACT (COVID-19)

Order Respecting Periods Established by the Firearms Act (COVID-19)

The Minister of Public Safety and Emergency Preparedness, pursuant to subsection 7(1) of the Time Limits and Other Periods Act (COVID-19)footnote c, makes the annexed Order Respecting Periods Established by the Firearms Act (COVID-19).

Ottawa, September 14, 2020

William Sterling Blair
Minister of Public Safety and Emergency Preparedness

Order Respecting Periods Established by the Firearms Act (COVID-19)

Extension

Extension of periods — subsections 64(1), (3) and (4)

1 The validity periods of a licence that are established by subsections 64(1), (3) and (4) of the Firearms Act and that end before December 31, 2020 are extended until that day.

Extension of period — subsection 64(1.1)

2 The period of six months referred to in subsection 64(1.1) of the Firearms Act is extended until December 31, 2020, if that period ends before that day.

Extension of period — subsection 64(2)

3 A validity period of a licence established by subsection 64(2) of the Firearms Act and that ends before December 31, 2020 is extended

Coming into Force

September 23, 2020

4 This Order comes into force on September 23, 2020, but if it is made after that day, it comes into force on the day on which it is made.

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.

Position Organization Closing date
Member Atlantic Pilotage Authority Canada  
President and Chief Executive Officer Atomic Energy of Canada Limited  
Director Business Development Bank of Canada  
Director — Board Risk Committee Chairperson Business Development Bank of Canada  
President and Chief Executive Officer Canada Development Investment Corporation  
Commissioner for Employers Canada Employment Insurance Commission  
Commissioner for Workers Canada Employment Insurance Commission  
President and Chief Executive Officer Canada Lands Company Limited  
President Canada Mortgage and Housing Corporation  
Member (Federal) Canada—Newfoundland and Labrador Offshore Petroleum Board  
President Canadian Commercial Corporation  
Commissioner (full-time), Commissioner (part-time) Canadian Energy Regulator  
Director Canadian Energy Regulator  
Chief Commissioner Canadian Grain Commission  
Commissioner Canadian Grain Commission  
Member Canadian Human Rights Tribunal  
Chairperson Canadian International Trade Tribunal  
Chairperson Canadian Museum of History  
Permanent Member Canadian Nuclear Safety Commission  
Executive Director Canadian Race Relations Foundation  
President Canadian Space Agency  
Chairperson Canadian Transportation Agency  
Temporary Member Canadian Transportation Agency  
Chief Administrator Courts Administration Service  
Director Export Development Canada  
Director Farm Credit Canada  
Chairperson Federal Public Sector Labour Relations and Employment Board  
Vice-Chairperson Federal Public Sector Labour Relations and Employment Board  
Chairperson Great Lakes Pilotage Authority Canada  
Director (Federal) Hamilton-Oshawa Port Authority  
Member, Northwest Territories Historic Sites and Monuments Board of Canada  
Assistant Deputy Chairperson Immigration and Refugee Board of Canada  
Member (appointment to roster) International Trade and International Investment Dispute Settlement Bodies  
Chairperson The Jacques Cartier and Champlain Bridges Incorporated  
Chairperson Marine Atlantic Inc.  
Director (Federal) Nanaimo Port Authority  
Secretary National Battlefields Commission  
Member Natural Sciences and Engineering Research Council of Canada  
Taxpayers’ Ombudsman Office of the Taxpayers’ Ombudsman  
Veterans’ Ombudsman Office of the Veterans’ Ombudsman  
Member Payments in Lieu of Taxes Dispute Advisory Panel  
Chairperson Polar Knowledge Canada  
Member Polar Knowledge Canada  
President Polar Knowledge Canada  
Director Public Sector Pension Investment Board  
Commissioner Roosevelt Campobello International Park Commission  
Member Social Sciences and Humanities Research Council of Canada  
President Social Sciences and Humanities Research Council of Canada  
Registrar Supreme Court of Canada  
Member Telefilm Canada  
Chairperson and Member Transportation Appeal Tribunal of Canada  
Member Transportation Appeal Tribunal of Canada  
Vice-Chairperson Transportation Appeal Tribunal of Canada  

TREASURY BOARD SECRETARIAT

TIME LIMITS AND OTHER PERIODS ACT (COVID-19)

Order Extending a Time Limit Established by the Pension Benefits Division Act (COVID-19)

The President of the Treasury Board, pursuant to subsection 7(1) of the Time Limits and Other Periods Act (COVID-19)footnote c, makes the annexed Order Extending a Time Limit Established by the Pension Benefits Division Act (COVID-19).

Ottawa, September 23, 2020

Jean-Yves Duclos
President of the Treasury Board

Order Extending a Time Limit Established by the Pension Benefits Division Act (COVID-19)

Extension of 180 days

1 The time limit of 60 days established by subsection 6(1) of the Pension Benefits Division Act is extended by 180 days or to December 31, 2020, if that day occurs before the day on which the 180-day extension ends.

TREASURY BOARD SECRETARIAT

TIME LIMITS AND OTHER PERIODS ACT (COVID-19)

Order Respecting Time Limits Established by or Under the Lieutenant Governors Superannuation Act (COVID-19)

The President of the Treasury Board, pursuant to subsections 7(1) and (5) of the Time Limits and Other Periods Act (COVID-19) footnote c, makes the annexed Order Respecting Time Limits Established by or Under the Lieutenant Governors Superannuation Act (COVID-19).

Ottawa, September 23, 2020

Jean-Yves Duclos
President of the Treasury Board

Order Respecting Time Limits Established by or Under the Lieutenant Governors Superannuation Act (COVID-19)

Extensions

Lieutenant Governors Superannuation Act

Extension – 180 days

1 The time limits established by subsections 3(3) and 5(1) of the Lieutenant Governors Superannuation Act are extended by 180 days or to December 31, 2020 if that day occurs before the day on which the 180-day extension ends.

Lieutenant Governors Superannuation Regulations

Extension – 180 days

2 The time limit established by subsection 4(2) of the Lieutenant Governors Superannuation Regulations is extended by 180 days or to December 31, 2020 if that day occurs before the day on which the 180-day extension ends.

Coming into Force

March 13, 2020

3 This Order is deemed to have come into force on March 13, 2020.

TREASURY BOARD SECRETARIAT

TIME LIMITS AND OTHER PERIODS ACT (COVID-19)

Order Respecting Time Limits Established by or Under the Members of Parliament Retiring Allowances Act (COVID-19)

The President of the Treasury Board, pursuant to subsections 7(1) and (5) of the Time Limits and Other Periods Act (COVID-19)footnote c, makes the annexed Order Respecting Time Limits Established by or Under the Members of Parliament Retiring Allowances Act (COVID-19).

Ottawa, September 23, 2020

Jean-Yves Duclos
President of the Treasury Board

Order Respecting Time Limits Established by or Under the Members of Parliament Retiring Allowances Act (COVID-19)

Extensions

Members of Parliament Retiring Allowances Act

Extension – 180 days

1 The time limits established by subsections 10(1) and 32(1) of the Members of Parliament Retiring Allowances Act are extended by 180 days or to December 31, 2020 if that day occurs before the day on which the 180-day extension ends.

Former Members of Parliament Elections for Joint and Survivor Benefits Regulations

Extension – 180 days

2 The time limits established by sections 5 and 8 and subsection 14(3) of the Former Members of Parliament Elections for Joint and Survivor Benefits Regulations are extended by 180 days or to December 31, 2020 if that day occurs before the day on which the 180-day extension ends.

Recovery of Overpayments Made to Former Members of Parliament Regulations

Extension – 180 days

3 The time limit established under subsection 3(2) of the Recovery of Overpayments Made to Former Members of Parliament Regulations is extended by 180 days or to December 31, 2020 if that day occurs before the day on which the 180-day extension ends.

Coming into Force

March 13, 2020

4 This Order is deemed to have come into force on March 13, 2020.

TREASURY BOARD SECRETARIAT

TIME LIMITS AND OTHER PERIODS ACT (COVID-19)

Order Respecting Time Limits Established by or Under the Public Service Superannuation Act (COVID-19)

The President of the Treasury Board, pursuant to subsections 7(1) and (5) of the Time Limits and Other Periods Act (COVID-19)footnote c, makes the annexed Order Respecting Time Limits Established by or Under the Public Service Superannuation Act (COVID-19).

Ottawa, September 23, 2020

Jean-Yves Duclos
President of the Treasury Board

Order Respecting Time Limits Established by or Under the Public Service Superannuation Act (COVID-19)

Extension

Extension of time limit

1 A time limit set out in column 2 of a Part of the schedule and established under the provision set out in column 1 is extended by 180 days or to December 31, 2020, if that day occurs before the day on which the 180-day extension ends.

Coming into Force

March 13, 2020

2 This Order is deemed to have come into force on March 13, 2020.

SCHEDULE

(Section 1)

Extended Time Limits

PART 1

Public Service Superannuation Act
Item

Column 1

Provision

Column 2

Time Limit Being Extended
1 clause 6(1)(b)(iii)(A) 1 year
2 clause 6(1)(b)(iii)(B) 1 year
3 clause 6(1)(b)(iii)(C) 1 year
4 clause 6(1)(b)(iii)(D) 1 year
5 clause 6(1)(b)(iii)(E) 1 year
6 clause 6(1)(b)(iii)(F) 1 year
7 clause 6(1)(b)(iii)(H) 1 year
8 clause 6(1)(b)(iii)(I) 1 year
9 clause 6(1)(b)(iii)(J) 1 year
10 section 9 1 year
11 subsection 10(4) 3 months
12 paragraph 10(5)(a) 1 year
13 subsection 25(7) 3 months
14 subsection 39(1) 1 year
15 subsection 40(11) 1 year
16 subsection 51(1) 1 year
17 paragraph 51(2)(a) 30 days
18 paragraph 51(2)(b) 30 days
19 subsection 51(3) 30 days
20 subsection 57(2) 30 days

PART 2

Counting of Service by Former Members of the Senate or House of Commons Regulations
Item

Column 1

Provision

Column 2

Time Limit Being Extended
1 subsection 5(1) 1 year
2 subsection 5(2) 1 year
3 subsection 6.1(2) 30 days
4 paragraph 9(a) 1 year

PART 3

Public Service Superannuation Regulations
Item

Column 1

Provision

Column 2

Time Limit Being Extended
1 paragraph 5(1)(a) end of the month
2 subsection 5(2) 30 days
3 subsection 6(2) 30 days
4 subsection 7.2(2) in advance of each year of a period of absence
5 subsection 7.2(2) in advance of each quarter of a period of absence
6 paragraph 8.1(a) 3 months after the day on which the contributor returns to duty
7 subsection 8.2(3) 3 months
8 subsection 13.3(1) 2 years
9 paragraph 19.1(a) 3 months
10 paragraph 19.1(c) 3 months
11 paragraph 19.1(c) 6 months
12 subsection 43.1(2) 6 months
13 paragraph 48(3)(a) immediately upon electing to pay
14 paragraph 48(3)(b) immediately upon completing a period of five continuous years
15 paragraph 48(3)(c) immediately upon attaining the age of 55 years
16 paragraph 48(4)(a) 30 days
17 paragraph 48(4)(b) 1 year
18 paragraph 49(2)(b) 1 year
19 subsection 49(4) 1 year
20 paragraph 54(1)(d) 90th day
21 subsection 57(2) while employed in operational service
22 paragraph 57(3)(a) 1 year
23 subsection 58(3) 1 year
24 section 60 1 year
25 subsection 61(2) 3 months
26 section 64 1 year
27 section 67 1 year
28 paragraph 74(3)(a) 3 months
29 paragraph 74(3)(b) 3 months
30 section 85 1 year after the date on which the contributor ceases to be employed in the public service
31 section 85 1 year after the date on which the contributor ceases to be employed by the new employer
32 paragraph 86(1)(b) 6 months
33 subsection 86(4) 3 months
34 paragraph 87(b) 1 year
35 paragraph 101(3)(a) first anniversary of the date of the written notice
36 paragraph 101(3)(b) first anniversary of the date of the written notice
37 subsection 104(2) 90th day

PART 4

Public Service Superannuation Special Election Regulations
Item

Column 1

Provision

Column 2

Time Limit Being Extended
1 subsection 4(1) 1 year

PART 5

Supplementary Death Benefit Regulations
Item

Column 1

Provision

Column 2

Time Limit Being Extended
1 section 7 in advance annually
2 section 7 in advance quarterly
3 section 7 in advance of the participant’s absence from duty
4 subsection 24(4) 1 year

PART 6

Portions of the Public Service General Divestiture Regulations
Item

Column 1

Provision

Column 2

Time Limit Being Extended
1 subsection 3(2) 1 year

TREASURY BOARD SECRETARIAT

TIME LIMITS AND OTHER PERIODS ACT (COVID-19)

Order Respecting Time Limits Established by the Diplomatic Service (Special) Superannuation Act (COVID-19)

The President of the Treasury Board, pursuant to subsections 7(1) and (5) of the Time Limits and Other Periods Act (COVID-19)footnote c, makes the annexed Order Respecting Time Limits Established by the Diplomatic Service (Special) Superannuation Act (COVID-19).

Ottawa, September 23, 2020

Jean-Yves Duclos
President of the Treasury Board

Order Respecting Time Limits Established by the Diplomatic Service (Special) Superannuation Act (COVID-19)

Extension

Extension – 180 days

1 The time limits established by subsections 7(1) and 11(1) of the Diplomatic Service (Special) Superannuation Act are extended by 180 days or to December 31, 2020 if that day occurs before the day on which the 180-day extension ends.

Coming into Force

March 13, 2020

2 This Order is deemed to have come into force on March 13, 2020.