Canada Gazette, Part I, Volume 155, Number 21: GOVERNMENT NOTICES

May 22, 2021

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2021-87-06-02 Amending the Non-domestic Substances List

Whereas, pursuant to subsection 87(5) of the Canadian Environmental Protection Act, 1999^{footnote a}, the Minister of the Environment has added the substances referred to in the annexed Order to the Domestic Substances List^{footnote b};

Therefore, the Minister of the Environment, pursuant to subsection 87(5) of the Canadian Environmental Protection Act, 1999^{footnote a}, makes the annexed Order 2021-87-06-02 Amending the Non-domestic Substances List.

Gatineau, May 6, 2021

Jonathan Wilkinson
Minister of the Environment

Order 2021-87-06-02 Amending the Non-domestic Substances List

Amendment

1 Part I of the Non-domestic Substances List^{footnote 1} is amended by deleting the following:

• 27289-84-5
• 68512-17-4
• 76326-99-3
• 86013-04-9

Coming into Force

2 This Order comes into force on the day on which Order 2021-87-06-01 Amending the Domestic Substances List comes into force.

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Significant New Activity Notice No. 20598

Significant New Activity Notice

(Section 110 of the Canadian Environmental Protection Act, 1999)

Whereas the Minister of the Environment and the Minister of Health have assessed information in their possession in respect of the living organism Bacillus amyloliquefaciens subspecies amyloliquefaciens strain P6T48 under section 108 of the Canadian Environmental Protection Act, 1999;

Whereas the living organism is not specified on the Domestic Substances List;

And whereas the ministers suspect that a significant new activity in relation to the living organism may result in the living organism becoming toxic within the meaning of section 64 of the Act,

Therefore, the Minister of the Environment indicates, pursuant to section 110 of the Canadian Environmental Protection Act, 1999, that subsection 106(4) of that act applies with respect to the living organism in accordance with the Annex.

The Honourable Jonathan Wilkinson
Minister of the Environment

ANNEX

Information Requirements

(Section 110 of the Canadian Environmental Protection Act, 1999)

1. In relation to the living organism identified as Bacillus amyloliquefaciens subspecies amyloliquefaciens strain P6T48, a significant new activity is any use of the living organism other than its use

• (a) in cleaning or degreasing products not intended for application to a natural environment;
• (b) for controlling odours in dumpsters and trash compactors; or
• (c) for treatment of water in any artificial aquatic environment such as aquariums and ornamental ponds.

2. Despite section 1, the following do not constitute a significant new activity:

• (a) the use of the living organism as a research and development organism as defined in subsection 1(1) of the New Substances Notification Regulations (Organisms), if
  • (i) the living organism is for introduction in an agricultural research study conducted on plants and all the conditions set out in paragraphs 2.1(1)(a) to (e) of the Regulations are met, or
  • (ii) the living organism is not for introduction outside a contained facility as defined in subsection 1(1) of the Regulations, and the living organism is:
    • (A) imported to the contained facility in a quantity that, at the time of the import, is less than 50 millilitres or 50 grams, or
    • (B) manufactured in the contained facility and at any given moment there is less than 1000 litres of the living organism present at that facility;
• (b) the use of the living organism for the production of substances in a contained facility, as defined in subsection 1(1) of the Regulations, and not for introduction outside the contained facility; or
• (c) the sale and distribution of the living organism for the uses mentioned in paragraphs 1(a) to (c).

3. For each proposed significant new activity, the following information must be provided to the Minister of the Environment at least 120 days before the day on which the activity begins:

• (a) a description of the significant new activity in relation to the living organism;
• (b) the information specified in items 2 and 3 of Schedule 1 of the Regulations;
• (c) the data and report from a test conducted in conformity with the guideline developed by Environment and Climate Change Canada's publication EPS1/RM/44, entitled Guidance Document for Testing the Pathogenicity and Toxicity of New Microbial Substances to Aquatic and Terrestrial Organisms, that is current at the time the test data are developed to determine the effects of the living organism alone on
  • (i) aquatic invertebrate species likely to be exposed to it in the course of the significant new activity, and
  • (ii) terrestrial invertebrate species likely to be exposed to it in the course of the significant new activity;
• (d) a description of the test procedures followed in developing the test data mentioned in paragraph 3(c), including a description or copy of test methods and of the quality control and quality assurance procedures followed in developing the test data;
• (e) all other information or test data in respect of the living organism that are in the possession of the person proposing the significant new activity, or to which they may reasonably be expected to have access, and that permit the identification of hazards of the living organism to the environment and human health and the degree of environmental and public exposure to the living organism;
• (f) the name of every government department or government agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the use of the living organism and, if known, the department's or agency's file number and, if any, the outcome of the department's or agency's assessment and the risk management actions in relation to the living organism imposed by the department or agency;
• (g) the name, civic and postal addresses, telephone number and, if any, the fax number and email address of the person who is proposing the significant new activity and, if they are not resident in Canada, of the person resident in Canada who is authorized to act on their behalf;
• (h) the name, civic and postal addresses, telephone number and, if any, the fax number and email address of the head of the quality assurance unit of every laboratory that developed test data included in the information; and
• (i) a certification that the information is accurate and complete, dated and signed by the person who is proposing the significant new activity if they are resident in Canada or, if not, by the person resident in Canada who is authorized to act on their behalf.

4. The test data and the test report referred to in paragraph 3(c) must be produced in accordance with the OECD Principles of Good Laboratory Practice set out in Annex II of the Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted by the Organisation for Economic Co-operation and Development on May 12, 1981, that are current at the time the tests are conducted.

5. The information provided under section 3 is to be assessed within 120 days after the day on which it is received by the Minister of the Environment.

EXPLANATORY NOTE

(This explanatory note is not part of the Significant New Activity Notice.)

Description

This Significant New Activity (SNAc) Notice is a legal instrument adopted by the Minister of the Environment pursuant to section 110 of the Canadian Environmental Protection Act, 1999 (the Act) to apply the SNAc provisions of that Act to the living organism Bacillus amyloliquefaciens subspecies amyloliquefaciens strain P6T48. The Notice is now in force, and it is legally binding. It is therefore mandatory for a person who intends to use the living organism for a significant new activity as defined in the Notice to meet all the applicable requirements set out in the Notice.

A SNAc Notice does not constitute an endorsement from the Minister of the Environment, the Department of the Environment or the Government of Canada of the living organism to which it relates, nor does it constitute an exemption from any other laws or regulations that are in force in Canada and that may apply to this living organism or activities involving the living organism.

Applicability of the Significant New Activity Notice

The Notice requires that any person (individual or corporation) engaging in a significant new activity in relation to the living organism Bacillus amyloliquefaciens subspecies amyloliquefaciens strain P6T48 submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Notice at least 120 days prior to using the living organism for the significant new activity.

In order to address the environmental concerns, the Notice requires notification in relation to any use of the living organism other than the following:

• (1) in cleaning or degreasing products not intended for application directly to a natural environment;
• (2) controlling odours in dumpsters or trash compactors;
• (3) for treatment of water in artificial aquatic environments such as aquariums as well as ornamental ponds and pools.

For example, notification is required if a person plans to use the living organism in bioremediation.

A SNAN is required 120 days before the use of the living organism in a significant new activity.

Activities not subject to the Notice

Uses of the living organism that are regulated under the acts of Parliament listed in Schedule 4 of the Act, including the Pest Control Products Act, the Fertilizers Act and the Feeds Act are excluded from the Notice.

Activities involving the use of the living organism as a research and development organism meeting the conditions set out in the Notice are excluded from the Notice. The term “research and development organism” is defined in subsection 1(1) of the New Substances Notification Regulations (Organisms).

Information to be submitted

The Notice sets out the information that must be provided to the Minister 120 days before the day on which the living organism Bacillus amyloliquefaciens subspecies amyloliquefaciens strain P6T48 is used for a significant new activity. The Department of the Environment and the Department of Health will use the information submitted in the SNAN to conduct a risk assessment within 120 days after the complete information is received.

The risk assessment of the living organism identified potential concerns associated with use of the organism in activities resulting in its release above certain concentrations to natural aquatic environments, such as water treatment for fish and seafood aquaculture and treatment of wastewater, or to terrestrial environments, such as the reduction of odour in manure intended for use as fertilizer in agricultural fields. This living organism is a bacteria which can potentially cause adverse effects to aquatic and terrestrial invertebrates. The SNAc Notice is issued to gather information to ensure that the living organism will undergo further assessment before significant new activities are undertaken.

The information requirements in the Notice relate to the notified activity, the introduction of the living organism in the environment following the new activity and the effects of the living organism on aquatic and terrestrial invertebrates. Some of the information requirements reference the New Substances Notification Regulations (Organisms).

Additional guidance on preparing a SNAN can be found in section 1.2 of the Guidelines for the Notification and Testing of New Substances: Organisms.

Compliance

When assessing whether or not a living organism is subject to SNAc provisions, a person is expected to make use of information in their possession or to which they may reasonably have access. This means information in any of the notifier's offices worldwide or other locations where the notifier can reasonably have access to the information.

If any information becomes available that reasonably supports the conclusion that the living organism is toxic or capable of becoming toxic, the person who is in possession of or that has knowledge of the information and is involved in activities with the living organism is obligated, under section 70 of the Act, to provide that information to the Minister without delay.

A company can submit a SNAN on behalf of its clients. For example, in cases where a person takes possession or control of a living organism from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by an original SNAN submitted by the person from whom they obtained the living organism.

Under section 111 of the Act, any person who transfers the physical possession or control of a living organism subject to a SNAc notice must notify all persons to whom the physical possession or control is transferred of the obligation to comply with the notice, including the obligation to notify the Minister of any SNAc and to provide all the required information outlined above.

A pre-notification consultation (PNC) is recommended for notifiers who wish to consult with the program during the planning or preparation of their SNAN to discuss any questions or concerns they have about the prescribed information and test plans.

For further information, please contact the Substances Management Information Line (eccc.substances.eccc@canada.ca [email], 1‑800‑567‑1999 [toll-free in Canada], and 819‑938‑3232 [outside of Canada]).

The Act is enforced in accordance with the publicly available Compliance and Enforcement Policy for the Canadian Environmental Protection Act, 1999. In instances of non-compliance, consideration is given to factors such as the nature of the alleged violation, potential harm, intent, and history of compliance.

DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of a substance — phenol, 4-chloro-3-methyl (chlorocresol), CAS RN ^{footnote 1} 59-50-7 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas chlorocresol is a substance identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;^{footnote 2}

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

And whereas it is concluded that the substance meets one or more 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 recommend to the Administrator in Council that this substance be added to Schedule 1 of the Act.

Notice is furthermore given that the ministers are releasing a proposed risk management approach document for chlorocresol on the Canada.ca (Chemical Substances) website to continue discussions with stakeholders on the manner in which the ministers intend to develop a proposed regulation or instrument respecting preventive or control actions in relation to the substance.

Public comment period on the risk management approach

Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the proposed risk management approach document. 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 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.

Jonathan Wilkinson
Minister of the Environment

Patty Hajdu
Minister of Health

ANNEX
Summary of the screening assessment of chlorocresol

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of phenol, 4-chloro-3-methyl-, hereinafter referred to as chlorocresol. The Chemical Abstracts Service Registry Number (CAS RN) for chlorocresol is 59-50-7. This substance was identified as a priority for assessment, as it met categorization criteria under subsection 73(1) of CEPA.

Chlorocresol was included in a survey issued pursuant to section 71 of CEPA. There were no reports of manufacture of chlorocresol in Canada above the reporting threshold of 100 kg in 2011. Chlorocresol was reported as being imported into Canada with a total volume in the range of 100 to 1 000 kg for commercial uses as a component in an admixture to concrete. Other uses in Canada include as a component in certain body moisturizer creams/lotions at concentrations up to 0.2%. Chlorocresol was also identified as a non-medicinal ingredient in licensed natural health product creams at concentrations up to 0.2%, as a non-medicinal ingredient in a limited number of pharmaceuticals at concentrations up to 0.1%, and as an active ingredient in one registered pest control product in Canada, which is formulated into concrete admixtures. The sodium salt form of chlorocresol is also registered in two pest control products.

The ecological risk of chlorocresol was characterized using the ecological risk classification of organic substances (ERC), which is a risk-based approach that employs multiple metrics for both hazard and exposure, with weighted consideration of multiple lines of evidence for determining risk classification. Hazard profiles are based principally on metrics regarding mode of toxic action, chemical reactivity, food web – derived internal toxicity thresholds, bioavailability, and chemical and biological activity. Metrics considered in the exposure profiles include potential emission rate, overall persistence, and long-range transport potential. A risk matrix is used to assign a low, moderate or high level of potential concern for substances on the basis of their hazard and exposure profiles. Based on the outcome of the ERC analysis, chlorocresol is considered unlikely to be causing ecological harm.

Considering all available lines of evidence presented in this screening assessment, there is a low risk of harm to the environment from chlorocresol. It is concluded that chlorocresol does not meet the criteria under paragraph 64(a) or (b) of CEPA, as it is 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.

On the basis of the low volumes of chlorocresol reported in commerce in Canada, and the low frequency of detection of chlorocresol in Canadian drinking water, wastewater treatment system sludge and indoor air, exposure to the general population to chlorocresol from environmental media is expected to be minimal. Accordingly, risk to human health is considered to be low.

Consumer exposure is not expected from small quantities of chlorocresol used for commercial purposes in certain building or construction materials as a concrete admixture.

In Canada, exposure to chlorocresol may occur through the use of certain body moisturizer creams/lotions, or topical licensed natural health products or pharmaceuticals in which it is present at concentrations up to 0.2%. The highest exposures were estimated for the use of moisturizers when applied to infants (birth to six months old).

The critical health effect for chlorocresol was identified as decreased adrenal gland weights in a chronic exposure study. A comparison of estimated exposure to chlorocresol from its use in body lotions to the critical health effect level resulted in margins of exposure (MOEs) that were considered inadequate to address uncertainties in the health effects and exposure databases.

With respect to short-term dermal exposure to chlorocresol from the use of topical licensed natural health products or pharmaceuticals, a comparison of the estimated exposure to the critical effect level resulted in MOEs that are considered adequate to address uncertainties in the health effects and exposure databases.

Considering all the information presented in this screening assessment, it is concluded that chlorocresol 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.

Overall conclusion

It is concluded that chlorocresol meets one or more of the criteria set out in section 64 of CEPA.

Chlorocresol has been determined to not meet the persistence and bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA.

The screening assessment and the risk management approach document for this substance is available on the Canada.ca (Chemical Substances) website.

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating 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 c} of the Food and Drugs Act^{footnote d}, makes the annexed Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19.

Ottawa, May 3, 2021

Patricia Hajdu
Minister of Health

Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19

Interpretation

Definitions

1 The following definitions apply in this Interim Order.

COVID-19

means the coronavirus disease 2019. (COVID-19)

COVID-19 drug

means a drug for human use that is manufactured, sold or represented for use in relation to COVID-19. (drogue utilisée en lien avec la COVID-19)

COVID-19 drug authorization

means an authorization to do any of the following activities:

• (a) import or sell a COVID-19 drug that is to be tested in a clinical trial; and
• (b) conduct a clinical trial in respect of such a drug. (autorisation relative à une drogue utilisée en lien avec la COVID-19)

COVID-19 medical device

means a medical device that is manufactured, sold or represented for use in relation to COVID-19. (instrument médical utilisé en lien avec la COVID-19)

COVID-19 medical device authorization

means an authorization to do any of the following activities:

• (a) import or sell a COVID-19 medical device that is to be tested in a clinical trial; and
• (b) conduct a clinical trial in respect of such a device. (autorisation relative à un instrument médical utilisé en lien avec la COVID-19)

incident

means any incident involving a COVID-19 medical device that is tested in a clinical trial that

• (a) is related to a failure of the device or a deterioration in its quality or effectiveness or any inadequacy in its labelling or its directions for use; or
• (b) has led to the death or a serious deterioration in the state of health of a clinical trial subject, user or other person or could do so were it to recur. (incident)

qualified investigator

means a person who is a member in good standing of a professional association of persons entitled under the laws of a province to provide health care under their licence in that province and who

• (a) conducts a clinical trial; or
• (b) in the case of a clinical trial conducted by a team, is the responsible leader of that team. (chercheur compétent)

research ethics board

means a body that is not affiliated with an applicant for a COVID-19 medical device authorization or a COVID-19 drug authorization, or a holder of such an authorization, and whose principal mandate is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human subjects in order to ensure the protection of their rights, safety and well-being. (comité d’éthique de la recherche)

Words and expressions

2 (1) Unless the context requires otherwise, words and expressions used in this Interim Order have the same meaning as in the Medical Devices Regulations and the Food and Drug Regulations, as applicable.

Definition of clinical trial

(2) Despite subsection (1), clinical trial has the same meaning as in section 2 of the Act, except as otherwise provided.

Application

Application

3 (1) This Interim Order applies to the importation and sale of a COVID-19 medical device, other than a Class I device, that is to be tested in a clinical trial, to the importation and sale of a COVID-19 drug, other than a drug that is described in Schedule C to the Act, that is to be tested in a clinical trial and to the conduct of a clinical trial in respect of such a device or drug.

Non-application — COVID-19 medical device

(2) The Medical Devices Regulations do not apply to the importation or sale of a COVID-19 medical device that is to be tested in a clinical trial or to the conduct of a clinical trial in respect of such a device if those activities are authorized by a COVID-19 medical device authorization and the authorization has not been revoked in whole.

Non-application — COVID-19 drug

(3) The following regulations do not apply to the importation or sale of a COVID-19 drug that is to be tested in a clinical trial or to the conduct of a clinical trial in respect of such a drug if those activities are authorized by a COVID-19 drug authorization and the authorization has not been revoked in whole:

• (a) the Food and Drug Regulations, other than sections A.01.022 to A.01.024, A.01.026, A.01.041, A.01.042, A.01.050, A.01.067, A.01.068, C.01.015, C.01.036, C.01.037 to C.01.040, C.01.040.2, C.01.051, C.01.064 to C.01.067, C.01.070, C.01.131, C.01.133 to C.01.136 and C.01.435 and Divisions 2 and 4 of Part C; and
• (b) the Blood Regulations.

PART 1
COVID-19 Medical Devices

Application

4 (1) An application for a COVID-19 medical device authorization must be submitted to the Minister in the form and manner specified by the Minister.

Content

(2) The application must contain sufficient information and material to enable the Minister to determine whether to issue the authorization and must include the following:

• (a) the name and contact information of the applicant and, if applicable, the importer;
• (b) the name and class of the device;
• (c) a description of the device and of the materials used in its manufacture and packaging;
• (d) a description of the features of the device that permit it to be used for the medical conditions, purposes and uses for which it is manufactured, sold or represented, including its performance specifications if those specifications are necessary for proper use;
• (e) the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
• (f) the name and contact information of the manufacturer as they appear on the device label;
• (g) the address where the device is manufactured, if the address is different from the one provided in the contact information under paragraph (f);
• (h) the diagnosis, treatment, mitigation or prevention for which the device is required;
• (i) a list of the countries other than Canada where the device has been sold, the total number of units sold in those countries and a summary of any reported problems with the device and of any recalls of the device in those countries;
• (j) the known information in relation to the quality, safety and effectiveness of the device;
• (k) the directions for use, unless directions are not required for the device to be used safely and effectively;
• (l) an attestation by the applicant that documented procedures are in place in respect of distribution records, complaint handling, incident reporting and recalls;
• (m) a copy of the label of the device;
• (n) the name of the qualified investigator and their qualifications, including their training and experience;
• (o) the name and contact information of the institution at which the clinical trial is proposed to be conducted;
• (p) the protocol of the proposed clinical trial, including the number of clinical trial subjects, the number of units of the device proposed to be used for the clinical trial, the hypothesis for and objective of the clinical trial, the period of time during which the clinical trial will be conducted and a copy of the informed consent form;
• (q) a written undertaking from the qualified investigator to
  • (i) conduct the clinical trial in accordance with the protocol provided by the applicant,
  • (ii) inform each clinical trial subject of any risks and benefits associated with the use of the device and obtain the subject's informed consent for its use, and
  • (iii) not permit the device to be used by any other person except under the direction of the qualified investigator; and
• (r) in the case of a Class III or IV device, for each clinical trial site, the name and contact information of the research ethics board that approved the protocol and informed consent form referred to in paragraph (p), if known at the time of submitting the application.

Class II devices

(3) Despite subsection (2), if the application for the authorization is in respect of a COVID-19 medical device that is a Class II device, the information and material set out in paragraphs (2)(c), (h) to (j), (n) and (q) may be omitted from the application.

Issuance

5 The Minister must issue a COVID-19 medical device authorization if the following requirements are met:

• (a) the applicant has submitted to the Minister an application that meets the requirements set out in section 4;
• (b) the applicant has submitted to the Minister any additional information or material requested under subsection 10(1) in the time, form and manner specified under subsection 10(2); and
• (c) the Minister determines that
  • (i) the use of the device that is to be tested in the clinical trial will not unduly affect the health or safety of clinical trial subjects, users or other persons,
  • (ii) the clinical trial is not contrary to the best interests of clinical trial subjects, and
  • (iii) the objectives of the clinical trial are achievable.

Research ethics board approval

6 A holder of a COVID-19 medical device authorization must not import or sell a COVID-19 medical device for which the authorization has been issued or conduct a clinical trial in respect of such a device unless the holder has obtained, for each clinical trial site, the approval of a research ethics board in respect of the protocol and informed consent form referred to in paragraph 4(2)(p).

Terms and conditions

7 The Minister may, at any time, impose terms and conditions on a COVID-19 medical device authorization or amend those terms and conditions.

Amendment

8 A holder of a COVID-19 medical device authorization must not import or sell a COVID-19 medical device for which the authorization has been issued or conduct a clinical trial in respect of such a device if the substance of any of the information or material referred to in subsection 4(2) and, if applicable, submitted under subsection 10(1) is significantly different from the substance of the information or material contained in the application, unless

• (a) the holder has submitted to the Minister an application to amend the authorization;
• (b) the Minister determines that the requirements set out in subparagraphs 5(c)(i) to (iii) are met;
• (c) the holder has submitted to the Minister any additional information or material requested under subsection 10(1) in the time, form and manner specified under subsection 10(2); and
• (d) the Minister amends the authorization.

Suspension

9 (1) The Minister may suspend, in whole or in part, a COVID-19 medical device authorization by notice, giving reasons, if

• (a) the Minister determines that any of the requirements set out in subparagraphs 5(c)(i) to (iii) is no longer met;
• (b) the holder of the authorization has not submitted to the Minister any additional information or material requested under subsection 10(1) in the time, form and manner specified under subsection 10(2); or
• (c) the holder of the authorization has contravened this Interim Order or any provisions of the Act relating to the device.

Reinstatement

(2) The Minister must reinstate a COVID-19 medical device authorization if the holder of the authorization submits 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.

Additional information and material

10 (1) The Minister may request that an applicant for a COVID-19 medical device authorization or a holder of such an authorization submit any additional information or material, including samples, that is necessary to enable the Minister to determine whether to issue, amend or suspend the authorization.

Form and manner

(2) The applicant or holder must submit the information or material in the time, form and manner specified by the Minister.

Discontinuance

11 If a holder of a COVID-19 medical device authorization discontinues, in whole or in part, the clinical trial for which the authorization has been issued, the holder must, without delay,

• (a) notify the Minister, in writing, of the discontinuance and the reasons for it;
• (b) inform all qualified investigators, in writing, of the discontinuance and the reasons for it and advise them, in writing, of any potential risks to the health of clinical trial subjects, users or other persons; and
• (c) in respect of each clinical trial site at which the trial is discontinued, stop the importation or sale of the device as of the date of the discontinuance and take all reasonable measures to ensure the recovery of all unused quantities of the device that have been sold.

Discretionary revocation

12 (1) The Minister may revoke, in whole or in part, a COVID-19 medical device authorization by notice, giving reasons, if the holder of the authorization has not submitted to the Minister, in the time, form and manner specified by the Minister, the information or material referred to in subsection 9(2).

Mandatory revocation

(2) The Minister must revoke, in whole or in part, the authorization if the Minister has received a notice of discontinuance referred to in paragraph 11(a).

Labelling

13 (1) A person must not import or sell a COVID-19 medical device for which a COVID-19 medical device authorization has been issued or conduct a clinical trial in respect of such a device unless the device has a label that sets out the following information:

• (a) the name of the device;
• (b) the name and contact information of the manufacturer;
• (c) the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or device group family;
• (d) in the case of a Class III or IV device, the control number;
• (e) if the contents are not readily apparent, an indication of what the package contains, expressed in terms appropriate to the device, such as the size, net weight, length, volume or number of units;
• (f) a statement indicating that the device is sterile, if the device is to be sold in a sterile condition;
• (g) the expiry date of the device, if the device has one;
• (h) the medical conditions, purposes and uses for which the device is manufactured, sold or represented, including its performance specifications if those specifications are necessary for proper use;
• (i) the directions for use, unless directions are not required for the device to be used safely and effectively;
• (j) any special storage conditions applicable to the device;
• (k) a statement indicating that the device is an investigational device;
• (l) a statement indicating that the device is to be used by qualified investigators only; and
• (m) in the case of an in vitro diagnostic device, a statement indicating that the performance specifications of the device have not been established.

Presentation of information

(2) The information required by subsection (1) to be set out on the label must be in English and in French.

Incident reporting

14 A holder of a COVID-19 medical device authorization must, within 10 days after becoming aware of an incident inside or outside Canada involving a COVID-19 medical device for which the authorization has been issued, report the incident to the Minister and specify the nature of the incident and the circumstances surrounding it.

Records

15 (1) A holder of a COVID-19 medical device authorization must record, handle and store all information in respect of the clinical trial for which the authorization has been issued in a manner that allows for the complete and accurate reporting as well as the interpretation and verification of the information.

Content

(2) The holder of the authorization must maintain complete and accurate records, which include the information and material referred to in subsection 4(2), in respect of a COVID-19 medical device for which the authorization has been issued in order to establish that the clinical trial is conducted in accordance with this Interim Order.

Retention period

(3) The holder of the authorization must retain all records for the period during which this Interim Order is in force.

Distribution records

16 (1) A holder of a COVID-19 medical device authorization must maintain a distribution record in respect of each device that is imported or sold under the authorization or tested in a clinical trial under the authorization.

Withdrawal

(2) The distribution record must contain sufficient information to permit complete and rapid withdrawal of the COVID-19 medical device for which the authorization has been issued.

Retention period

(3) The holder of the authorization must retain the distribution record for the period during which this Interim Order is in force.

Timely retrieval

(4) Distribution records must be maintained in a manner that will allow their timely retrieval.

Complaint handling

17 A holder of a COVID-19 medical device authorization must, in respect of a COVID-19 medical device for which the authorization has been issued, maintain records of the following:

• (a) any reported problems relating to the performance characteristics or safety of the device that are received by the holder after the device was first sold in Canada; and
• (b) all actions taken by the holder in response to those problems.

Documented procedures

18 A holder of a COVID-19 medical device authorization must, in respect of a COVID-19 medical device for which the authorization has been issued, establish and implement documented procedures that will enable the holder to carry out

• (a) an effective and timely investigation of the problems referred to in paragraph 17(a); and
• (b) an effective and timely recall of the device.

Information — recall

19 (1) A holder of a COVID-19 medical device authorization must, on or before recalling a COVID-19 medical device for which the authorization has been issued, provide the Minister with the following:

• (a) the name of the device and its identifier, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;
• (b) the name and contact information of the manufacturer and, if applicable, the importer and the name and contact information of the establishment where the device was manufactured, if different from that of the manufacturer;
• (c) the reason for the recall, the nature of the defectiveness or possible defectiveness and the date on and circumstances under which the defectiveness or possible defectiveness was discovered;
• (d) an evaluation of the risk associated with the defectiveness or possible defectiveness;
• (e) the number of affected units of the device that were manufactured or sold in Canada or imported into Canada;
• (f) the period during which the affected units of the device were sold in Canada;
• (g) the name of each person to whom the affected device was sold and the number of units sold to each person;
• (h) a copy of any communication issued with respect to the recall;
• (i) the proposed strategy for conducting the recall, including the date for beginning the recall, information as to how and when the Minister will be informed of the progress of the recall and the proposed date for its completion;
• (j) the proposed action to prevent a recurrence of the problem; and
• (k) the name, title and telephone number of the representative of the holder of the authorization to contact for any information concerning the recall.

Information — after completion of recall

(2) The holder of the authorization must, as soon as feasible after the completion of the recall, prepare and submit to the Minister

• (a) the results of the recall; and
• (b) the action taken to prevent a recurrence of the problem.

Submission on holder's behalf

(3) Despite subsections (1) and (2), the holder of the authorization may permit the importer of the COVID-19 medical device to prepare and submit, on the holder's behalf, the information and material required under those subsections if the importer has the same information and material.

Notice to Minister

(4) The holder of the authorization must notify the Minister, in writing, if the holder has permitted the importer to prepare and submit the information and material with respect to the recall on the holder's behalf.

PART 2

COVID-19 Drugs

Application

20 (1) An application for a COVID-19 drug authorization must be signed and dated by the applicant's senior medical or scientific officer in Canada and their senior executive officer and must be submitted to the Minister in the form and manner specified by the Minister.

Content

(2) The application must contain sufficient information and material to enable the Minister to determine whether to issue the authorization and must include the following:

• (a) the protocol of the proposed clinical trial;
• (b) a copy of the statement, as it will be set out in each informed consent form, that states the risks and anticipated benefits arising to the health of clinical trial subjects as a result of their participation in the clinical trial;
• (c) a clinical trial attestation containing
  • (i) the title of the protocol and the clinical trial number,
  • (ii) the brand name, chemical name or code for the drug,
  • (iii) the therapeutic and pharmacological classifications of the drug,
  • (iv) the medicinal ingredients of the drug,
  • (v) the non-medicinal ingredients of the drug,
  • (vi) the dosage form of the drug,
  • (vii) the name and contact information of the applicant,
  • (viii) if the drug is to be imported, the name and contact information of the applicant's representative in Canada who is responsible for the sale of the drug,
  • (ix) for each clinical trial site, the name and contact information of the qualified investigator, if known at the time of submitting the application,
  • (x) for each clinical trial site, the name and contact information of the research ethics board that approved the protocol referred to in paragraph (a) and the informed consent form containing the statement referred to in paragraph (b), if known at the time of submitting the application, and
  • (xi) a statement that
    • (A) the clinical trial will be conducted in accordance with good clinical practices and this Interim Order, and
    • (B) all information and material contained in, or referenced by, the application is complete and accurate and is not false or misleading;
• (d) the name and contact information of any research ethics board that has previously refused to approve the protocol referred to in paragraph (a), its reasons for doing so and the date on which the refusal was given, if known at the time of submitting the application;
• (e) the physical, chemical and pharmaceutical properties of the drug;
• (f) the pharmacological aspects of the drug, including its metabolites in all animal species tested;
• (g) the pharmacokinetics of the drug and the drug metabolism, including the biological transformation of the drug in all animal species tested;
• (h) any toxicological effects of the drug in any animal species tested under a single dose study, a repeated dose study or a special study;
• (i) any results of carcinogenicity studies in any animal species tested in respect of the drug;
• (j) any results of clinical pharmacokinetic studies of the drug;
• (k) any information regarding drug safety, pharmacodynamics, efficacy and dose responses of the drug that were obtained from previous clinical trials in humans;
• (l) if the drug contains a human-sourced excipient, including any used in the placebo,
  • (i) a statement indicating that the excipient has been assigned a drug identification number under subsection C.01.014.2(1) of the Food and Drug Regulations or, in the case of a new drug, has been issued a notice of compliance under subsection C.08.004(1) of those Regulations, or
  • (ii) in any other case, sufficient information to support the identity, purity, potency, stability and safety of the excipient;
• (m) if the drug has not been assigned a drug identification number under subsection C.01.014.2(1) of the Food and Drug Regulations or, in the case of a new drug, a notice of compliance has not been issued under section C.08.004 or C.08.004.01 of those Regulations, the chemistry and manufacturing information in respect of the drug, including its site of manufacture; and
• (n) the proposed date for the commencement of the clinical trial at each clinical trial site, if known at the time of submitting the application.

Marketed drug

(3) If the application for the authorization is in respect of a COVID-19 drug that meets the requirements of paragraphs 27(a) to (c), the application must also contain

• (a) a copy of the label of the drug; and
• (b) information on how the proposed use of the drug is consistent with the standard of medical practice.

Issuance

21 The Minister must issue a COVID-19 drug authorization if the following requirements are met:

• (a) the applicant has submitted to the Minister an application that meets the requirements set out in section 20;
• (b) the applicant has submitted to the Minister any additional information or material requested under subsection 30(1) in the time, form and manner specified under subsection 30(2); and
• (c) the Minister determines that
  • (i) the use of the drug that is to be tested in the clinical trial will not unduly affect the health or safety of clinical trial subjects or other persons,
  • (ii) the clinical trial is not contrary to the best interests of clinical trial subjects, and
  • (iii) the objectives of the clinical trial are achievable.

Additional information prior to clinical trial

22 A holder of a COVID-19 drug authorization must not import or sell a COVID-19 drug for which the authorization has been issued or conduct a clinical trial in respect of such a drug unless the holder has

• (a) for each clinical trial site, obtained the approval of a research ethics board in respect of the protocol referred to in paragraph 20(2)(a) and the informed consent form that contains the statement referred to in paragraph 20(2)(b); and
• (b) submitted to the Minister the information and material referred to in subparagraphs 20(2)(c)(ix) and (x) and paragraphs 20(2)(d) and (n), if it was not submitted at the time of submitting the application.

Terms and conditions

23 The Minister may, at any time, impose terms and conditions on a COVID-19 drug authorization or amend those terms and conditions.

Amendment

24 (1) A holder of a COVID-19 drug authorization must not import or sell a COVID-19 drug for which the authorization has been issued or conduct a clinical trial in respect of such a drug if the substance of any of the information or material referred to in paragraph 20(2)(a) or (m) is significantly different from the substance of the information or material contained in the application, unless

• (a) the holder has submitted to the Minister an application to amend the authorization;
• (b) for each clinical trial site, the holder has obtained the approval of a research ethics board in respect of the protocol referred to in paragraph 20(2)(a) and the informed consent form that contains the statement referred to in paragraph 20(2)(b);
• (c) the holder has submitted to the Minister the information and material referred to in subparagraphs 20(2)(c)(ix) and (x) and paragraphs 20(2)(d) and (n), if it was not submitted at the time of submitting the application;
• (d) the Minister determines that the requirements set out in subparagraphs 21(c)(i) to (iii) are met;
• (e) the holder has submitted to the Minister any additional information or material requested under subsection 30(1) in the time, form and manner specified under subsection 30(2); and
• (f) the Minister amends the authorization.

Immediate change

(2) Despite subsection (1), if the holder of the authorization is required to make an immediate change to the substance of any of the information or material referred to in paragraph 20(2)(a) or (m) because the clinical trial or the use of the COVID-19 drug that is tested in the clinical trial endangers the health of a clinical trial subject or other person, the holder may immediately make the change.

Application to amend

(3) The holder of the authorization must, within 15 days after the day on which the change is made, submit an application under subsection (1) to amend the authorization.

Prohibition — import

25 A holder of a COVID-19 drug authorization must not import a COVID-19 drug for which the authorization has been issued if the sale of the drug would constitute a violation of the Act.

Prohibition — import and sale

26 A holder of a COVID-19 drug authorization must not import or sell a COVID-19 drug for which the authorization has been issued unless the holder has a representative in Canada who is responsible for the sale of the drug.

Marketed drugs

27 Paragraphs 20(2)(e) to (l), section 33 and paragraphs 35(2)(a) to (c) do not apply to a COVID-19 drug for which a COVID-19 drug authorization has been issued if

• (a) the use of the drug is consistent with the standard of medical practice;
• (b) the drug has been issued a notice of compliance under subsection C.08.004(1) of the Food and Drug Regulations or has been assigned a drug identification number under subsection C.01.014.2(1) of those Regulations; and
• (c) the clinical trial for which the authorization has been issued is in respect of a purpose or condition of use other than that for which the notice of compliance was issued or drug identification number was assigned.

Good clinical practices

28 A holder of a COVID-19 drug authorization must ensure that the clinical trial for which the authorization has been issued is conducted in accordance with good clinical practices and, without limiting the generality of the foregoing, must ensure that

• (a) the clinical trial is scientifically sound and clearly described in the protocol;
• (b) the clinical trial is conducted, and the drug is used, in accordance with the protocol and this Interim Order;
• (c) systems and procedures that assure the quality of every aspect of the clinical trial are implemented;
• (d) for each clinical trial site, the approval of a research ethics board is obtained before the clinical trial begins;
• (e) at each clinical trial site, there is no more than one qualified investigator;
• (f) at each clinical trial site, medical care and medical decisions, in respect of the clinical trial, are under the supervision of a health care professional who is authorized to provide medical care and make medical decisions;
• (g) each person who is involved in the conduct of the clinical trial is qualified by education, training and experience to perform their respective tasks;
• (h) informed consent, given in accordance with the applicable laws governing consent, is obtained from every person before they participate in the clinical trial, but only after that person has been informed of
  • (i) the risks and anticipated benefits to their health arising from participation in the clinical trial, and
  • (ii) all other aspects of the clinical trial that are necessary for that person to make the decision to participate in the clinical trial; and
• (i) the drug is manufactured, handled and stored in accordance with the applicable good manufacturing practices referred to in Divisions 2 and 4 of Part C of the Food and Drug Regulations, with the exception of sections C.02.019, C.02.025 and C.02.026 of those Regulations.

Suspension

29 (1) The Minister may suspend, in whole or in part, a COVID-19 drug authorization by notice, giving reasons, if

• (a) the Minister determines that any of the requirements set out in subparagraphs 21(c)(i) to (iii) is no longer met;
• (b) the holder of the authorization has not submitted to the Minister any additional information or material requested under subsection 30(1) in the time, form and manner specified under subsection 30(2); or
• (c) the holder of the authorization has contravened this Interim Order or any provisions of the Act relating to the drug.

Reinstatement

(2) The Minister must reinstate a COVID-19 drug authorization if the holder of the authorization submits 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.

Additional information and material

30 (1) The Minister may request that an applicant for a COVID-19 drug authorization or a holder of such an authorization submit any additional information or material, including samples, that is necessary to enable the Minister to determine whether to issue, amend or suspend the authorization.

Form and manner

(2) The applicant or holder must submit the information or material in the time, form and manner specified by the Minister.

Discontinuance

31 If a holder of a COVID-19 drug authorization discontinues, in whole or in part, the clinical trial for which the authorization has been issued, the holder must, without delay,

• (a) notify the Minister, in writing, of the discontinuance and the reasons for it;
• (b) inform all qualified investigators, in writing, of the discontinuance and the reasons for it and advise them, in writing, of any potential risks to the health of clinical trial subjects or other persons; and
• (c) in respect of each clinical trial site at which the trial is discontinued, stop the importation or sale of the drug as of the date of the discontinuance and take all reasonable measures to ensure the recovery of all unused quantities of the drug that have been sold.

Discretionary revocation

32 (1) The Minister may revoke, in whole or in part, a COVID-19 drug authorization by notice, giving reasons, if the holder of the authorization has not submitted to the Minister, in the time, form and manner specified by the Minister, the information or material referred to in subsection 29(2).

Mandatory revocation

(2) The Minister must revoke, in whole or in part, the authorization if the Minister has received a notice of discontinuance referred to in paragraph 31(a).

Labelling

33 (1) A person must not import or sell a COVID-19 drug for which a COVID-19 drug authorization has been issued or conduct a clinical trial in respect of such a drug unless the drug has a label that sets out the following information:

• (a) a statement indicating that the drug is an investigational drug to be used only by a qualified investigator;
• (b) the name, number or identifying mark of the drug;
• (c) the expiration date of the drug;
• (d) the recommended storage conditions for the drug;
• (e) the lot number of the drug;
• (f) the name and contact information of the holder of the authorization; and
• (g) the protocol code or identification.

Presentation of information

(2) The information required by subsection (1) to be set out on the label must be in English and in French.

Serious unexpected adverse drug reaction

34 A holder of a COVID-19 drug authorization must inform the Minister of any serious unexpected adverse drug reaction that has occurred inside or outside Canada, in respect of the COVID-19 drug that is tested in the clinical trial, as follows:

• (a) within 15 days after becoming aware of the reaction, if it is neither fatal nor life-threatening; and
• (b) within seven days after becoming aware of the reaction, if it is fatal or life-threatening.

Records

35 (1) A holder of a COVID-19 drug authorization must record, handle and store all information in respect of the clinical trial for which the authorization has been issued in a manner that allows for the complete and accurate reporting as well as the interpretation and verification of the information.

Content

(2) The holder of the authorization must maintain complete and accurate records in respect of a COVID-19 drug for which the authorization has been issued in order to establish that the clinical trial is conducted in accordance with good clinical practices and this Interim Order, and that include the following:

• (a) the information and material referred to in paragraphs 20(2)(e) to (k);
• (b) records respecting each change made to the information and material referred to in paragraph (a), the rationale for each change and documentation that supports each change;
• (c) records respecting all adverse events in respect of the drug that have occurred inside or outside Canada, including the indication for use and the dosage form of the drug at the time of the adverse event;
• (d) in respect of a drug that meets the requirements of paragraphs 27(a) to (c), records respecting any serious unexpected adverse drug reaction that has occurred inside or outside Canada;
• (e) records respecting the enrolment of clinical trial subjects, including information that allows all subjects to be identified and contacted in the event that the sale of the drug may endanger the health of the subjects or other persons;
• (f) records respecting the shipment, receipt, disposition, return and destruction of the drug;
• (g) for each clinical trial site, an undertaking from the qualified investigator that is signed and dated by them prior to the commencement of their responsibilities in respect of the clinical trial that states that
  • (i) the qualified investigator will conduct the clinical trial in accordance with good clinical practices, and
  • (ii) the qualified investigator will immediately, on discontinuance of the clinical trial, in whole or in part, by the holder, inform both the clinical trial subjects and the research ethics board of the discontinuance, provide them with the reasons for the discontinuance and advise them, in writing, of any potential risks to the health of subjects or other persons;
• (h) for each clinical trial site, a copy of the protocol, informed consent form and any amendment to the protocol or informed consent form that have been approved by a research ethics board for that clinical trial site; and
• (i) for each clinical trial site, an attestation, signed and dated by a research ethics board, stating that it has reviewed and approved the protocol and informed consent form and that the board carries out its functions in a manner consistent with good clinical practices.

Retention period

(3) The holder of the authorization must retain all records for the period during which this Interim Order is in force.

PART 3
General

Remote written informed consent

36 (1) If a qualified investigator is not able to obtain, in person, the written informed consent of a person to participate in a clinical trial in respect of a COVID-19 medical device for which a COVID-19 medical device authorization has been issued or a COVID-19 drug for which a COVID-19 drug authorization has been issued, the qualified investigator may obtain the written informed consent remotely.

Non-written informed consent

(2) In the case where the person is not able to provide their written informed consent, the qualified investigator may obtain their non-written informed consent if the following conditions are met:

• (a) the qualified investigator reads the contents of the informed consent form to the person;
• (b) the person provides their informed consent before a witness; and
• (c) an attestation by the witness that the person has provided their informed consent is provided to the qualified investigator as soon as feasible.

PART 4
Other Clinical Trials

Exemption — certain drugs

37 (1) A person that is authorized under Division 5 of Part C of the Food and Drug Regulations to sell or import a drug for the purposes of a clinical trial — and any other person that conducts the clinical trial — is, in respect of the clinical trial, exempt from section 3.1 of the Act.

Clarification — suspension and cancellation

(2) For greater certainty, the exemption does not apply

• (a) if the authorization to sell or import the drug is suspended in its entirety; or
• (b) in respect of the conduct of the clinical trial at a clinical trial site, if the authorization to sell or import the drug is suspended or cancelled in respect of that site.

Definition of clinical trial

(3) In this section, clinical trial has the same meaning as in section C.05.001 of the Food and Drug Regulations.

Exemption — positron-emitting radiopharmaceuticals

38 (1) A person that is authorized under Division 3 of Part C of the Food and Drug Regulations to sell or import a positron-emitting radiopharmaceutical for the purposes of a study — and any other person that conducts the study — is, in respect of the study, exempt from section 3.1 of the Act.

Clarification — suspension and cancellation

(2) For greater certainty, the exemption does not apply

• (a) if the authorization to sell or import the radiopharmaceutical is suspended in its entirety; or
• (b) in respect of the conduct of the study at a study site, if the authorization to sell or import the radiopharmaceutical is suspended or cancelled in respect of that site.

Exemption — natural health products

39 (1) A person that is authorized under Part 4 of the Natural Health Products Regulations to sell or import a natural health product for the purposes of a clinical trial — and any other person that conducts the clinical trial — is, in respect of the clinical trial, exempt from section 3.1 of the Act.

Clarification — suspension and cancellation

(2) For greater certainty, the exemption does not apply

• (a) if the authorization to sell or import the natural health product is suspended in its entirety; or
• (b) in respect of the conduct of the clinical trial at a clinical trial site, if the authorization to sell or import the natural health product is suspended or cancelled in respect of that site.

Definitions

(3) The following definitions apply in this section.

clinical trial

has the same meaning as in section 63 of the Natural Health Products Regulations. (essai clinique)

natural health product

has the same meaning as in subsection 1(1) of the Natural Health Products Regulations. (produit de santé naturel)

Exemption — medical devices

40 (1) A person that is authorized under Part 3 of the Medical Devices Regulations to sell a medical device for investigational testing — and any person who conducts the testing of the device — is, in respect of the testing, exempt from section 3.1 of the Act.

Exception

(2) The exemption does not apply in respect of any person to whom the medical device can no longer be sold as a result of a measure taken by the Minister under subsection 85(2) of the Medical Devices Regulations.

Suspension — deemed holder

41 (1) An authorization to conduct a clinical trial in respect of a drug is suspended if

• (a) the holder is deemed to hold the authorization under any of sections 180 to 182 of the Budget Implementation Act, 2019, No. 1; and
• (b) the holder's authorization to sell or import the drug for the purposes of the clinical trial is suspended under
  • (i) section C.03.317, C.05.016 or C.05.017 of the Food and Drug Regulations, or
  • (ii) section 80 or 81 of the Natural Health Products Regulations.

Reinstatement

(2) An authorization that is suspended under subsection (1) is reinstated if the authorization referred to in paragraph (1)(b) is reinstated.

Revocation — deemed holder

(3) An authorization to conduct a clinical trial in respect of a drug or medical device is revoked if

• (a) the holder is deemed to hold the authorization under any of sections 180 to 183 of the Budget Implementation Act, 2019, No. 1; and
• (b) the holder's authorization to sell or import the drug or device for the purposes of the clinical trial is cancelled
  • (i) in the case of a drug, under
    • (A) section C.03.319 or paragraph C.05.016(4)(b) or C.05.017(3)(b) of the Food and Drug Regulations, or
    • (B) paragraph 82(b) of the Natural Health Products Regulations, and
  • (ii) in the case of a device, under paragraph 85(2)(b) of the Medical Devices Regulations.

Partial suspensions and cancellations

(4) If the authorization referred to in paragraph (1)(b) or (3)(b) is only partially suspended or cancelled, the authorization to conduct the clinical trial is suspended or revoked to the same extent.

PART 5
Transitional Provisions and Repeal

Transitional Provisions

Definition of Interim Order No. 1

42 In sections 43 to 52, Interim Order No. 1 means the Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19, made by the Minister on May 23, 2020 and published in the Canada Gazette, Part I, on June 6, 2020.

Applications

43 An application for a COVID-19 medical device authorization or a COVID-19 drug authorization that was submitted to the Minister under Interim Order No. 1 before the day on which this Interim Order is made and in respect of which no decision has been made before that day is deemed to be an application for a COVID-19 medical device authorization or a COVID-19 drug authorization submitted under this Interim Order.

Authorizations

44 A COVID-19 medical device authorization or a COVID-19 drug authorization that was issued or reinstated by the Minister under Interim Order No. 1 before the day on which this Interim Order is made and has not been revoked in whole before that day is deemed to be a COVID-19 medical device authorization or a COVID-19 drug authorization issued or reinstated under this Interim Order.

Approval — research ethics board

45 Any approval of a research ethics board that was obtained by the holder of a COVID-19 medical device authorization or the holder of a COVID-19 drug authorization under Interim Order No. 1 before the day on which this Interim Order is made is deemed to be an approval of the research ethics board obtained by the holder of a COVID-19 medical device authorization or the holder of a COVID-19 drug authorization under this Interim Order.

Terms and conditions

46 Any terms and conditions that were imposed on a COVID-19 medical device authorization or a COVID-19 drug authorization by the Minister under Interim Order No. 1 before the day on which this Interim Order is made are deemed to be terms and conditions imposed on the COVID-19 medical device authorization or the COVID-19 drug authorization under this Interim Order.

Amendment applications

47 An application to amend a COVID-19 medical device authorization or a COVID-19 drug authorization that was submitted to the Minister under Interim Order No. 1 before the day on which this Interim Order is made and in respect of which no decision has been made before that day is deemed to be an application to amend a COVID-19 medical device authorization or a COVID-19 drug authorization submitted under this Interim Order.

Amended authorization

48 A COVID-19 medical device authorization or a COVID-19 drug authorization that was amended by the Minister under Interim Order No. 1 before the day on which this Interim Order is made and has not been revoked in whole before that day is deemed to be a COVID-19 medical device authorization or a COVID-19 drug authorization amended to the same extent under this Interim Order.

Suspension

49 A COVID-19 medical device authorization or a COVID-19 drug authorization that was suspended in whole or in part by the Minister under Interim Order No. 1 before the day on which this Interim Order is made and has not been revoked in whole before that day is deemed to be a COVID-19 medical device authorization or a COVID-19 drug authorization suspended in whole or in part to the same extent under this Interim Order.

Request — additional information and material

50 A request that was made by the Minister under Interim Order No. 1 before the day on which this Interim Order is made for additional information or material, including samples, is deemed to be a request for additional information or material under this Interim Order.

Discontinuance

51 A notice of discontinuance provided to the Minister, or information in respect of the discontinuance provided in writing to the qualified investigator, by the holder of a COVID-19 medical device authorization or a COVID-19 drug authorization under Interim Order No. 1 before the day on which this Interim Order is made is deemed to be a notice of discontinuance or information provided under this Interim Order.

Revocation in part

52 A COVID-19 medical device authorization or a COVID-19 drug authorization that was revoked in part by the Minister under Interim Order No. 1 before the day on which this Interim Order is made and has not been revoked in whole before that day is deemed to be a COVID-19 medical device authorization or a COVID-19 drug authorization revoked in part to the same extent under this Interim Order.

Repeal

53 The Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19, made by the Minister of Health on May 23, 2020 and published in the Canada Gazette, Part I, on June 6, 2020, is repealed.

EXPLANATORY NOTE

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

Proposal

This interim order (IO) No. 2 was made by the Minister of Health on May 3, 2021. IO No. 2 repeals and replaces the (ARCHIVED) Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 (IO No. 1), which came into force on May 23, 2020.

Objective

IO No. 2 supports Canada's continued focus on dealing with the significant risk that COVID-19 continues to pose to the health and safety of Canadians.

Background

COVID-19

COVID-19 is a novel infectious respiratory disease caused by a strain of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease was first detected in December 2019. It is caused by a new strain of coronavirus never before seen in humans.

COVID-19 infection has been known to cause respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, it can cause pneumonia, acute respiratory distress syndrome, kidney failure and death.

The World Health Organization declared a global pandemic related to COVID-19 on March 11, 2020. COVID-19 has now affected most countries across the globe. According to the COVID-19 dashboard by the text-center for Systems Science and Engineering at Johns Hopkins University, there are now more than 120 million cases and over 2.5 million people have lost their lives. According to the outbreak update from the Government of Canada, the number of confirmed cases in Canada as of March 25, 2021, is over 900 000. The situation continues to evolve and change.

From the outset, the COVID-19 pandemic created an urgent need for drugs and devices used to diagnose, treat, mitigate or prevent COVID-19. The pandemic also created a need for a pathway to facilitate clinical trials for these potential COVID-19 drugs and medical devices.

Health Canada permits the importation and sale of drugs and devices in clinical trials if they meet safety requirements and if the trial is expected to meet its objectives. Among other requirements, Health Canada assesses available information about the drug or device. Health Canada also requires that a research ethics board review and approve a trial before it starts at each site.

While approved trials are ongoing, Health Canada monitors the emerging safety data by assessing serious unexpected adverse drug reactions, medical device incidents and other information. Health Canada may also carry out routine or for-cause inspections to verify that these clinical trials are taking place in accordance with the regulatory requirements.

Government of Canada's response

The health and safety of Canadians are the Government of Canada's top priority during the COVID-19 pandemic. Therefore, the Minister of Health took action to provide a more efficient way to conduct clinical trials related to COVID-19, while upholding strong patient safety requirements and validity of trial data.

IO No. 1 provided a new optional pathway for authorizing

• clinical trials for drugs, such as pharmaceuticals and biologics; and
• clinical trials for Class II to IV medical devices.

Clinical trials authorized under this pathway could assess

• the use of existing, marketed products in Canada as COVID-19 – related therapies; or
• new COVID-19 – related therapies currently under development.

The authorization scheme in IO No. 1 also gave the Minister a greater ability to

• oversee clinical trials and intervene, as needed; and
• request additional information, or suspend/cancel parts of or an entire authorization.

Thirty-six clinical trial applications have been submitted under this pathway as of April 16, 2021.

Order in Council SI/2020-39 that accompanied IO No. 1 brought into force several subsections of the Budget Implementation Act, 2019, No. 1, including section 3.1 of the Food and Drugs Act. This section prohibits the conduct of a clinical trial unless the person holds an authorization to do so.

Implications

In accordance with the Food and Drugs Act, IO No. 2 is in effect for 14 days unless approved by the Governor in Council.

Flexible pathway

As with the previous Interim Order, IO No. 2 increases efficiencies and reduces the administrative burden caused by certain requirements. This authorization pathway, established in IO No. 1 and now continued in IO No. 2, is designed to better facilitate clinical trials during a public health emergency. It also makes it easier to set up and run multi-site trials.

The pathway increases flexibility by, for example, expanding the scope of the definition of “qualified investigator” for clinical trials for drugs. This expanded scope permits additional licensed health care professionals, such as nurse practitioners, to fill that role. Only a physician or dentist may conduct a clinical trial under the pre-existing pathway in the Food and Drug Regulations.

This increased flexibility will help to facilitate trials

• across multiple sites; and
• in locations, such as remote Northern communities, where there are fewer physicians available to oversee them.

Through the pathway, an applicant for a medical device clinical trial authorization is not limited to a manufacturer and importer. An applicant may also be an investigator, such as researcher, clinician or health care facility. Under IO No. 1 and now IO No. 2, an investigator in a medical device clinical trial, independent of the medical device manufacturer, can also apply for an authorization.

The pathway also provides two other means of obtaining informed consent when prospective clinical trial participants are unable to consent in person or in writing:

1. permits remote, written informed consent of a prospective participant when they cannot be in the same location as the qualified investigator; and
2. permits non-written informed consent when a prospective participant cannot provide written informed consent.

These measures will also continue to reduce barriers to the provision of consent given the restrictions that are in place due to COVID-19. For instance, the infection control practices in most hospitals may prohibit people who are in isolation from accessing paper.

Other changes from the Food and Drug Regulations and Medical Devices Regulations introduced by the IO No. 1 pathway include

• reducing the requirements around communicating with Health Canada on changes that occur over the course of a trial;
• requiring amendment applications only for significant changes that carry potentially higher risks; and
• reducing the application, labelling and record-keeping requirements for marketed drugs already authorized in Canada for other uses and that are being used in COVID-19 – related clinical trials within the standard of medical practice.

Under IO No. 2, the Minister also continues to have the ability to partially suspend or revoke a trial authorization. This allows her to suspend a single treatment group of a randomized trial if needed, while allowing the rest of the trial to continue so that other participants may continue to receive a promising therapy. This ability offers increased flexibility for the type of innovative trial designs being pursued for COVID-19 drugs and devices.

Oversight of clinical trials

The health and safety of clinical trial participants are as important as ever. As with the previous interim order, IO No. 2 continues to provide the Minister with certain abilities to oversee and intervene in clinical trials, as needed, in the best interest of clinical trial participants.

These abilities include the use of terms and conditions on clinical trial authorizations, which may be applied on a case-by-case basis to address uncertainties and mitigate risks. Terms and conditions may include

• requiring more frequent safety reporting;
• monitoring specific populations because of potential increased risk (for example children); and
• requiring additional information to characterize and mitigate newly identified risks.

Another oversight ability permits the Minister to request additional information about a clinical trial application or authorization. This information may be considered necessary to enable the Minister to determine whether to issue, amend, suspend or cancel (in whole or in part) the authorization.

As with all clinical trials conducted in Canada, Health Canada will monitor the safety of the drugs and devices used under IO No. 2. If required, Health Canada will take immediate action, including the suspension or cancellation of authorizations, to protect the health and safety of Canadians.

IO No. 2 also includes provisions to ensure that all authorizations and suspensions for clinical trials issued under IO No. 1, including any terms and conditions, will remain in effect. Further, any applications made under IO No. 1 that are outstanding at the time of its repeal will be considered as applications made under IO No. 2.

As was the case under IO No. 1, the new authorization pathway is optional. The existing pathways in the Food and Drug Regulations and the Medical Devices Regulations continue to be available. Authorization holders continue to hold their existing authorizations under the regulatory framework for which they were approved.

IO No. 2 also addresses two concerns that were raised by the Standing Joint Committee for the Scrutiny of Regulations. These changes include

• correcting an inconsistency in the French text, with an amendment made to use only “précis” for the word “accurate”,
• the French text used both “exacts” and “précis” for the word “accurate” in the English text in IO No. 1; and
• clarifying that informed consent can be obtained in accordance with applicable laws governing consent, which includes remotely, as provided for in IO No. 2.

Consultation

Information gathered from the consultations held in the spring of 2020 for IO No. 1 helped to inform IO No. 2. Consultation sessions sought input on some of the concepts from key stakeholders, including

• research ethics boards across Canada;
• provincial and territorial governments;
• industry associations in the drug, medical device and biotechnology sectors; and
• Canadian Institutes of Health Research (CIHR).

Many aspects of IO No. 2 have leveraged elements from the forthcoming broader clinical trials modernization initiative. To date, outreach and other engagement activities have involved in-person and online consultations.

Health Canada continues to engage with the CIHR, the Canadian Association of Research Ethics Boards and other research ethics boards that review clinical trials in Canada. Engagement sessions on clinical trial oversight and implementation are held every month. Through this initiative, policymakers, regulators, funders and oversight bodies are collaborating and sharing information on clinical trials.

In December 2020, Health Canada informed industry, health care practitioners, hospital and university researchers, research institutes and academia, and health care partners about IO No. 2, including holding webinars. Written stakeholder feedback was encouraged between December 10, 2020, and January 25, 2021. There were no comments or questions related to IO No. 2.

Contact

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

DEPARTMENT OF INDUSTRY

OFFICE OF THE REGISTRAR GENERAL

Appointments

• Canadian Transportation Agency
  • Member and Chairperson
    • Pégeot, France, Order in Council 2021-366
• Chief Human Resources Officer
  • Donoghue, Christine, Order in Council 2021-353
• Court of Appeal of Quebec
  • Puisne Judge
    • Kalichman, The Hon. Peter, Order in Council 2021-326
• Deputy Minister of Canadian Heritage
  • Mondou, Isabelle, Order in Council 2021-352
• Federal Public Sector Labour Relations and Employment Board
  • Vice-Chairperson
    • Perrault, Marie-Claire, Order in Council 2021-345
• Superior Court of Quebec for the district of Montréal
  • Puisne Judges
    • Bienvenu, Charles, Order in Council 2021-328
    • Breault, The Hon. Annie, Order in Council 2021-327
• Supreme Court of British Columbia
  • Judges
    • Blake, Lauren, Order in Council 2021-330
    • Brongers, Jan E., Order in Council 2021-331
    • Lamb, Julianne K., Q.C., Order in Council 2021-329

May 11, 2021

Diane Belanger
Official Document Registrar

DEPARTMENT OF TRANSPORT

AERONAUTICS ACT

Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 28

Whereas the annexed Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 28 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 4.71^{footnote e} and 4.9^{footnote f}, paragraphs 7.6(1)(a)^{footnote g} and (b)^{footnote h} and section 7.7^{footnote i} of the Aeronautics Act^{footnote j};

And whereas, pursuant to subsection 6.41(1.2)^{footnote k} of that Act, the 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 Minister of Transport, pursuant to subsection 6.41(1)^{footnote k} of the Aeronautics Act ^{footnote j}, makes the annexed Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 28.

Ottawa, May 5, 2021

Omar Alghabra
Minister of Transport

Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 28

Interpretation

Definitions

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

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)

checked baggage

has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012. (bagages enregistrés)

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)

elevated temperature

means a temperature within the range set out in the standards. (température élevée)

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 officer

has the same meaning as in section 2 of the Canadian Air Transport Security Authority Act. (agent de contrôle)

standards

means the document entitled the Transport Canada Temperature Screening Standards, published by the Minister, as amended from time to time. (normes)

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:

• (a) it is made of multiple layers of tightly woven materials such as cotton or linen;
• (b) it completely covers a person's nose, mouth and chin without gaping;
• (c) it can be secured to a person's head with ties or ear loops.

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

• (a) the rest of the face mask is made of multiple layers of tightly woven materials such as cotton or linen; and
• (b) there is a tight seal between the transparent material and the rest of the face mask.

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 and prepaid accommodation

(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 by the electronic means specified by that Minister a suitable quarantine plan and evidence of prepaid accommodation arrangements that enables them to remain in quarantine at a government-authorized accommodation for a three-day period that begins on the day on which they enter Canada 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.

False declarations

(3) 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.

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 declaration

(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:

• (a) a crew member;
• (b) a person who provides a medical certificate certifying that any symptoms referred to in subsection 8(1) that they are exhibiting are not related to COVID-19.

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:

• (a) a fever;
• (b) a cough;
• (c) breathing difficulties.

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 not be permitted to board the aircraft if

• (a) they exhibit a fever and a cough or a fever and breathing difficulties, unless they provide a medical certificate certifying that their symptoms are not related to COVID-19;
• (b) they have, or suspect that they have, COVID-19;
• (c) they have been denied permission to board an aircraft in the previous 14 days for a medical reason related to COVID-19; or
• (d) in the case of a flight departing in Canada, they are the subject of a mandatory quarantine order as a result of recent travel or as a result of a local or provincial public health order.

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:

• (a) the person has, or suspects that they have, COVID-19;
• (b) the person has been denied permission to board an aircraft in the previous 14 days for a medical reason related to COVID-19;
• (c) in the case of a flight departing in Canada, the person is the subject of a mandatory quarantine order as a result of recent travel or as a result of a local or provincial public health order.

False declaration — 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 declaration — 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

• (a) answer all questions; and
• (b) not provide answers or a confirmation that they know to be false or misleading.

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

• (a) the person's answers to the health check questions indicate that they exhibit
  • (i) a fever and cough, or
  • (ii) a fever and breathing difficulties;
• (b) the private operator or air carrier observes that, as the person is boarding, they exhibit
  • (i) a fever and cough, or
  • (ii) a fever and breathing difficulties;
• (c) the person's confirmation under subsection 8(3) indicates that one of the situations described in paragraphs 8(3)(a), (b) or (c) applies to that person; or
• (d) the person is a competent adult and refuses to answer any of the questions asked of them under subsection 8(1) or to give the confirmation under subsection 8(3).

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 refusal, 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

10.1 (1) Sections 10.2 to 10.7 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 10.2 to 10.7 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

10.2 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 not be permitted 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

10.3 (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

• (a) a negative result for a COVID-19 molecular test that was performed on a specimen collected no more than 72 hours before the aircraft's initial scheduled departure time; or
• (b) a positive result for such a test that was performed on a specimen collected at least 14 days and no more than 90 days before the aircraft's initial scheduled departure time.

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

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

• (a) the person's name and date of birth;
• (b) the name and civic address of the laboratory that administered the test;
• (c) the date the specimen was collected and the test method used; and
• (d) the test result.

False or misleading evidence

10.5 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

10.6 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

10.7 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 10.3.

Temperature Screening — Flights to Canada

Application

11 (1) Sections 12 to 19 apply to an 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 19 do not apply to either of the following persons:

• (a) a child who is less than two years of age;
• (b) a person who provides a medical certificate certifying that their elevated temperature is not related to COVID-19.

Non-application — crew member

(3) Sections 12 to 15 do not apply to a crew member who underwent a temperature screening under section 22 for the duration of the shift during which the temperature screening was conducted.

Requirement

12 (1) Subject to subsection 19(2), an air carrier must conduct a temperature screening of every person boarding an aircraft for a flight that the air carrier operates. The screening must be conducted using equipment that complies with the standards and conducted according to the procedures set out in the standards.

Second screening

(2) The air carrier must conduct a second temperature screening if the first temperature screening indicates that the person has an elevated temperature. The second temperature screening must be conducted using equipment that complies with the standards and conducted according to the procedures set out in the standards.

Notification

13 (1) An air carrier must notify every person boarding an aircraft for a flight that the air carrier operates that they may not be permitted to board an aircraft for a flight to Canada for a period of 14 days if the temperature screening conducted under subsection 12(2) indicates that they have an elevated temperature, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Confirmation

(2) Before boarding an aircraft for a flight, every person must confirm to the air carrier operating the flight that they understand that they may not be permitted to board an aircraft for a flight to Canada for a period of 14 days if the temperature screening conducted under subsection 12(2) indicates that they have an elevated temperature, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Prohibition — elevated temperature

14 (1) If the temperature screening conducted under subsection 12(2) indicates that the person has an elevated temperature, the air carrier must

• (a) not permit the person to board the aircraft; and
• (b) notify the person that they are not permitted to board another aircraft for a flight to Canada for a period of 14 days after the refusal, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Prohibition — refusal

(2) If a person refuses to be subjected to a temperature screening, the air carrier must not permit the person to board the aircraft.

Period of 14 days

15 A person who is not permitted to board an aircraft under section 14 is not permitted to board another aircraft for a flight to Canada for a period of 14 days after the refusal, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Requirement — equipment

16 An air carrier must calibrate and maintain the equipment that it uses to conduct temperature screenings under subsection 12(2) to ensure that the equipment is in proper operating condition.

Requirement — training

17 An air carrier must ensure that the person using the equipment to conduct temperature screenings under subsection 12(2) has been trained to operate that equipment and interpret the data that it produces.

Record keeping — equipment

18 (1) An air carrier must keep a record of the following information in respect of each flight it operates:

• (a) the number of persons who were not permitted to board the aircraft under paragraph 14(1)(a);
• (b) the date and flight number;
• (c) the make and model of the equipment that the air carrier used to conduct the temperature screenings under subsection 12(2);
• (d) the date and time that that equipment was last calibrated and last maintained, as well as the name of the person who performed the calibration or maintenance; and
• (e) the results of the last calibration and the activities performed during the last maintenance of that equipment, including any corrective measures taken.

Record keeping — training

(2) An air carrier must keep a record of the name of every person who has received training under section 17, as well as the contents of the training.

Retention period

(3) The air carrier must

• (a) retain the records referred to in subsection (1) for a period of at least 90 days after the day of the flight; and
• (b) retain the records referred to in subsection (2) for a period of at least 90 days after the day on which the person received the training.

Ministerial request

(4) The air carrier must make the records referred to in subsections (1) and (2) available to the Minister on request.

Definition of authorized person

19 (1) For the purposes of this section, authorized person means a person authorized by a competent authority to conduct temperature screenings at an aerodrome located outside of Canada.

Exception

(2) An air carrier may rely on an authorized person to conduct the temperature screening under subsection 12(1), in which case subsection 12(2) and sections 13, 14 and 16 to 18 do not apply to that air carrier.

Notification

(3) The air carrier must notify every person boarding the aircraft for the flight that they are not permitted to board an aircraft for a flight to Canada for a period of 14 days if the temperature screening indicates that they have an elevated temperature, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Period of 14 days

(4) If the temperature screening indicates that a person has an elevated temperature, that person is not permitted to board an aircraft for a flight to Canada for a period of 14 days after the temperature screening, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Equipment

(5) The air carrier must ensure that the equipment used to conduct those temperature screenings is calibrated and maintained so that the equipment is in proper operating condition.

Temperature Screening — Aerodromes in Canada

Definition of screening authority

20 (1) For the purposes of this section and sections 21 to 31, screening authority has the same meaning as in section 3 of the Canadian Aviation Security Regulations, 2012.

Application

(2) Sections 21 to 31 apply to all of the following persons:

• (a) a person entering a restricted area within an air terminal building at an aerodrome listed in Schedule 2 from a non-restricted area;
• (b) a person undergoing a screening at a non-passenger screening checkpoint outside an air terminal building at an aerodrome listed in Schedule 2;
• (c) the operator of an aerodrome listed in Schedule 2;
• (d) a screening authority at an aerodrome listed in Schedule 2;
• (e) an air carrier operating a flight departing from an air terminal building at an aerodrome listed in Schedule 2.

Non-application

(3) Sections 21 to 31 do not apply to any of the following persons:

• (a) a child who is less than two years of age;
• (b) a person who provides a medical certificate certifying that their elevated temperature is not related to COVID-19;
• (c) a member of emergency response provider personnel who is responding to an emergency;
• (d) a peace officer who is responding to an emergency.

Requirement

21 A person entering a restricted area within an air terminal building from a non-restricted area within the air terminal building must do so at a passenger screening checkpoint or non-passenger screening checkpoint.

Requirement — temperature screening

22 (1) Subject to subsection (3), a screening authority must conduct a temperature screening of every person who presents themselves at a passenger screening checkpoint or non-passenger screening checkpoint within an air terminal building for the purpose of entering a restricted area from a non-restricted area and of every person undergoing a screening at a non-passenger screening checkpoint outside an air terminal building. The screening must be conducted using equipment that complies with the standards and conducted according to the procedures set out in the standards.

Second screening

(2) Following a rest period of 10 minutes, the screening authority must conduct a second temperature screening if the first temperature screening indicates that the person has an elevated temperature. The second temperature screening must be conducted using equipment that complies with the standards and conducted according to the procedures set out in the standards.

Exception

(3) If the temperature screening of a person, other than a passenger, who presents themselves at a passenger screening checkpoint or non-passenger screening checkpoint within an air terminal building for the purpose of entering a restricted area from a non-restricted area, or of a person who is undergoing a screening at a non-passenger screening checkpoint outside an air terminal building, indicates that the person does not have an elevated temperature, the screening authority is not required to conduct any further temperature screenings of that person for the duration of the day during which the temperature screening was conducted.

Notification — consequence of elevated temperature

23 (1) An air carrier must notify every person, other than a crew member, who intends to board an aircraft for a flight that the air carrier operates that they may not be permitted to board an aircraft for a flight originating in Canada and that they must not enter a restricted area at any aerodrome in Canada for a period of 14 days if the temperature screening conducted under subsection 22(2) indicates that they have an elevated temperature, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Confirmation — consequence of elevated temperature

(2) Before passing beyond a passenger screening checkpoint to board an aircraft for a flight, every person other than a crew member must confirm to the air carrier operating the flight that they understand that they may not be permitted to board an aircraft for a flight originating in Canada and that they must not enter a restricted area at any aerodrome in Canada for a period of 14 days if the temperature screening conducted under subsection 22(2) indicates that they have an elevated temperature, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Prohibition — elevated temperature

24 (1) If the temperature screening conducted under subsection 22(2) indicates that the person has an elevated temperature, the screening authority must

• (a) deny the person entry to the restricted area; and
• (b) notify the person that they are not permitted to board an aircraft for a flight originating in Canada or enter a restricted area at any aerodrome in Canada for a period of 14 days after the denial, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Prohibition — refusal

(2) If a person refuses to be subjected to a temperature screening, the screening authority must deny them entry to the restricted area.

Period of 14 days

25 A person who is denied entry to the restricted area under section 24 is not permitted to enter a restricted area at any aerodrome in Canada for a period of 14 days after the denial, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Denial — person intending to board aircraft

26 (1) If, under section 24, a screening authority denies entry to a restricted area to a person who intends to board an aircraft for a flight, other than a crew member, the screening authority must, for the purpose of paragraph 26(4)(a), notify the air carrier operating the flight that that person has been denied entry to the restricted area and provide the person's name and flight number to the air carrier.

Denial — person not intending to board aircraft

(2) If, under section 24, a screening authority denies entry to a restricted area to a person who does not intend to board an aircraft for a flight, the screening authority must, for the purpose of subsection 26(5), provide the following information to the operator of the aerodrome:

• (a) the person's name as it appears on their document of entitlement;
• (b) the number or identifier of the person's document of entitlement; and
• (c) the reason why the person was denied entry to the restricted area.

Denial — crew member

(3) If, under section 24, a screening authority denies entry to a restricted area to a crew member, the screening authority must provide the information referred to in subsection (2) to the air carrier for the purpose of allowing the air carrier to assign a replacement crew member, if necessary.

Denial — air carrier requirements

(4) An air carrier that has been notified under subsection (1) must

• (a) ensure that the person is directed to a location where they can retrieve their checked baggage, if applicable; and
• (b) if the person is escorted to a location where they can retrieve their checked baggage, ensure that the escort wears a face mask and maintains a distance of at least two metres between themselves and the person.

Denial — aerodrome operator requirement

(5) The operator of an aerodrome that has been notified under subsection (2) must suspend the person's restricted area entry privileges for a period of 14 days after the person was denied entry to the restricted area, unless the person provides a medical certificate certifying that their elevated temperature is not related to COVID-19.

Prohibition — restricted area

(6) If, under section 24, a screening authority denies entry to a restricted area to a crew member or to a person who does not intend to board an aircraft for a flight, the crew member or that person must not present themselves at a passenger screening checkpoint or non-passenger screening checkpoint at any aerodrome for the purpose of entering a restricted area for a period of 14 days after the denial, unless they provide a medical certificate certifying that their elevated temperature is not related to COVID-19.

Requirement — equipment

27 A screening authority must ensure that the equipment that it uses to conduct temperature screenings under section 22 is calibrated and maintained so that the equipment is in proper operating condition.

Requirement — training

28 A screening authority must ensure that the person using the equipment to conduct temperature screenings under section 22 has been trained to operate that equipment and interpret the data that it produces.

Record keeping — equipment

29 (1) A screening authority must keep a record of the following information with respect to any temperature screening it conducts:

• (a) the number of persons who are denied entry under paragraph 24(1)(a) at a passenger screening checkpoint;
• (b) the number of persons who are denied entry under paragraph 24(1)(a) at a non-passenger screening checkpoint;
• (c) the flight number of any person who is denied entry under paragraph 24(1)(a) at a passenger screening checkpoint and the date on which the person was denied entry;
• (d) the make and model of the equipment that the screening authority uses to conduct the temperature screenings under section 22;
• (e) the date and time when that equipment was calibrated and maintained, as well as the name of the person who performed the calibration or maintenance; and
• (f) the results of the calibration and the activities performed during the maintenance of that equipment, including any corrective measures taken.

Record keeping — training

(2) The screening authority must keep a record of the name of every person who has received training under section 28, as well as the contents of the training.

Retention

(3) The screening authority must

• (a) retain the records referred to in subsection (1) for a period of at least 90 days after the day on which the record was created; and
• (b) retain the records referred to in subsection (2) in accordance with any record retention requirements under the Privacy Act.

Ministerial request

(4) The screening authority must make the records referred to in subsections (1) and (2) available to the Minister on request.

Temperature screening facilities

30 The operator of an aerodrome must make facilities available for temperature screening that are accessible without having to enter a restricted area.

Requirement — air carrier representative

31 An air carrier must ensure that the screening authority at the aerodrome has been provided with the name and telephone number of the on-duty representative of the air carrier for the purpose of facilitating the return of checked baggage to persons who are denied entry to a restricted area under section 24.

Face Masks

Non-application

32 (1) Sections 33 to 38 do not apply to any of the following persons:

• (a) a child who is less than two years of age;
• (b) a child who is at least two years of age but less than six years of age who is unable to tolerate wearing a face mask;
• (c) a person who provides a medical certificate certifying that they are unable to wear a face mask for a medical reason;
• (d) a person who is unconscious;
• (e) a person who is unable to remove their face mask without assistance;
• (f) a crew member;
• (g) a gate agent.

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 35 and complies with any instructions given by a gate agent under section 36 if the child

• (a) is at least two years of age but less than six years of age and is able to tolerate wearing a face mask; or
• (b) is at least six years of age.

Notification

33 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

• (a) be in possession of a face mask before boarding;
• (b) wear the face mask at all times during the boarding process, during the flight and from the moment the doors of the aircraft are opened until the person enters the air terminal building; and
• (c) comply with any instructions given by a gate agent or a crew member with respect to wearing a face mask.

Obligation to possess face mask

34 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

35 (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

• (a) when the safety of the person could be endangered by wearing a face mask;
• (b) when the person is drinking or eating, unless a crew member instructs the person to wear a face mask;
• (c) when the person is taking oral medications;
• (d) when a gate agent or a crew member authorizes the removal of the face mask to address unforeseen circumstances or the person's special needs; or
• (e) when a gate agent, a member of the aerodrome security personnel or a crew member authorizes the removal of the face mask to verify the person's identity.

Exceptions — flight deck

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

• (a) a Department of Transport air carrier inspector;
• (b) an inspector of the civil aviation authority of the state where the aircraft is registered;
• (c) an employee of the private operator or air carrier who is not a crew member and who is performing their duties;
• (d) a pilot, flight engineer or flight attendant employed by a wholly owned subsidiary or a code share partner of the air carrier;
• (e) a person who has expertise related to the aircraft, its equipment or its crew members and who is required to be on the flight deck to provide a service to the private operator or air carrier.

Compliance

36 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

37 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

• (a) the person is not in possession of a face mask; or
• (b) the person refuses to comply with an instruction given by a gate agent or a crew member with respect to wearing a face mask.

Refusal to comply

38 (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

• (a) keep a record of
  • (i) the date and flight number,
  • (ii) the person's name, date of birth and contact information, including the person's home address, telephone number and email address,
  • (iii) the person's seat number, and
  • (iv) the circumstances related to the refusal to comply; and
• (b) inform the Minister as soon as feasible of any record created under paragraph (a).

Retention period

(2) The private operator or air carrier must retain the record referred to in paragraph (1)(a) for a period of at least 12 months after the day of the flight.

Ministerial request

(3) The private operator or air carrier must make the records referred to in paragraph (1)(a) available to the Minister on request.

Wearing of face mask — crew member

39 (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

• (a) when the safety of the crew member could be endangered by wearing a face mask;
• (b) when the wearing of a face mask by the crew member could interfere with operational requirements or the safety of the flight; or
• (c) when the crew member is drinking, eating or taking oral medications.

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

40 (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

• (a) when the safety of the gate agent could be endangered by wearing a face mask; or
• (b) when the gate agent is drinking, eating or taking oral medications.

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

41 (1) Section 42 does not apply to any of the following persons:

• (a) a child who is less than two years of age;
• (b) a child who is at least two years of age but less than six years of age who is unable to tolerate wearing a face mask;
• (c) a person who provides a medical certificate certifying that they are unable to wear a face mask for a medical reason;
• (d) a person who is unconscious;
• (e) a person who is unable to remove their face mask without assistance;
• (f) a person who is on a flight that originates in Canada and is destined to another country.

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 42 if the child

• (a) is at least two years of age but less than six years of age and is able to tolerate wearing a face mask; or
• (b) is at least six years of age.

Wearing of face mask — person

42 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

Definition of screening authority

43 (1) For the purposes of sections 44 and 47, 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.

Non-application

(2) Sections 44 to 47 do not apply to any of the following persons:

• (a) a child who is less than two years of age;
• (b) a child who is at least two years of age but less than six years of age who is unable to tolerate wearing a face mask;
• (c) a person who provides a medical certificate certifying that they are unable to wear a face mask for a medical reason;
• (d) a person who is unconscious;
• (e) a person who is unable to remove their face mask without assistance;
• (f) a member of emergency response provider personnel who is responding to an emergency;
• (g) a peace officer who is responding to an emergency.

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 subsection 44(2) and removes it when required by a screening officer to do so under subsection 44(3) if the child

• (a) is at least two years of age but less than six years of age and is able to tolerate wearing a face mask; or
• (b) is at least six years of age.

Requirement — passenger screening checkpoint

44 (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

45 (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

• (a) when the safety of the screening officer could be endangered by wearing a face mask; or
• (b) when the screening officer is drinking, eating or taking oral medications.

Exception — physical barrier

46 Sections 44 and 45 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

47 (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

48 (1) The provisions of this Interim Order set out in column 1 of Schedule 3 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 3 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

• (a) the particulars of the alleged contravention;
• (b) that the person on whom the notice is served or to whom it is sent has the option of paying the amount specified in the notice or filing with the Tribunal a request for a review of the alleged contravention or the amount of the penalty;
• (c) that payment of the amount specified in the notice will be accepted by the Minister in satisfaction of the amount of the penalty for the alleged contravention and that no further proceedings under Part I of the Act will be taken against the person on whom the notice in respect of that contravention is served or to whom it is sent;
• (d) that the person on whom the notice is served or to whom it is sent will be provided with an opportunity consistent with procedural fairness and natural justice to present evidence before the Tribunal and make representations in relation to the alleged contravention if the person files a request for a review with the Tribunal; and
• (e) that the person on whom the notice is served or to whom it is sent will be considered to have committed the contravention set out in the notice if they fail to pay the amount specified in the notice and fail to file a request for a review with the Tribunal within the prescribed period.

Repeal

49 The Interim Order Respecting Certain Requirements for Civil Aviation Due to COVID-19, No. 27, made on April 22, 2021, is repealed.

SCHEDULE 1

(Subsection 10.3(2))

Countries and Territories

Name
India
Pakistan

SCHEDULE 2

(Subsection 20(2))

Aerodromes

Name	ICAO Location Indicator
Calgary International Airport	CYYC
Edmonton International Airport	CYEG
Halifax / Robert L. Stanfield International Airport	CYHZ
Kelowna International Airport	CYLW
Montréal / Pierre Elliott Trudeau International Airport	CYUL
Ottawa / Macdonald-Cartier International Airport	CYOW
Québec / Jean Lesage International Airport	CYQB
Regina International Airport	CYQR
Saskatoon / John G. Diefenbaker International Airport	CYXE
St. John's International Airport	CYYT
Toronto / Billy Bishop Toronto City Airport	CYTZ
Toronto / Lester B. Pearson International Airport	CYYZ
Vancouver International Airport	CYVR
Victoria International Airport	CYYJ
Winnipeg / James Armstrong Richardson International Airport	CYWG

SCHEDULE 3

(Subsections 48(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 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 10.2	5,000	25,000
Subsection 10.3(1)	5,000
Section 10.5	5,000
Section 10.6	5,000	25,000
Section 10.7	5,000	25,000
Subsection 12(1)		25,000
Subsection 12(2)		25,000
Subsection 13(1)		25,000
Subsection 13(2)	5,000
Subsection 14(1)		25,000
Subsection 14(2)		25,000
Section 15	5,000
Section 16		25,000
Section 17		25,000
Subsection 18(1)		25,000
Subsection 18(2)		25,000
Subsection 18(3)		25,000
Subsection 18(4)		25,000
Subsection 19(3)		25,000
Subsection 19(4)	5,000
Subsection 19(5)		25,000
Section 21	5,000
Subsection 22(1)		25,000
Subsection 22(2)		25,000
Subsection 23(1)		25,000
Subsection 23(2)	5,000
Subsection 24(1)		25,000
Subsection 24(2)		25,000
Section 25	5,000
Subsection 26(1)		25,000
Subsection 26(2)		25,000
Subsection 26(3)		25,000
Subsection 26(4)		25,000
Subsection 26(5)		25,000
Subsection 26(6)	5,000
Section 27		25,000
Section 28		25,000
Subsection 29(1)		25,000
Subsection 29(2)		25,000
Subsection 29(3)		25,000
Subsection 29(4)		25,000
Section 30		25,000
Section 31		25,000
Subsection 32(2)	5,000
Subsection 32(3)	5,000
Section 33	5,000	25,000
Section 34	5,000
Subsection 35(1)	5,000	25,000
Section 36	5,000
Section 37	5,000	25,000
Subsection 38(1)	5,000	25,000
Subsection 38(2)	5,000	25,000
Subsection 38(3)	5,000	25,000
Subsection 39(1)	5,000	25,000
Subsection 40(1)	5,000	25,000
Subsection 41(2)	5,000
Section 42	5,000
Subsection 43(3)	5,000
Subsection 44(1)		25,000
Subsection 44(2)	5,000
Subsection 44(3)	5,000
Subsection 44(4)	5,000
Subsection 45(1)	5,000
Subsection 45(2)	5,000
Subsection 47(1)		25,000
Subsection 47(2)		25,000

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
Member	Atlantic Pilotage Authority Canada
Commissioner	British Columbia Treaty Commission
Director	Business Development Bank of Canada
President and Chief Executive Officer	Business Development Bank of Canada
Member	Canada Council for the Arts
Vice-Chairperson	Canada Council for the Arts
President and Chief Executive Officer	Canada Development Investment Corporation
Commissioner for Employers	Canada Employment Insurance Commission
Director	Canada Infrastructure Bank
Director	Canada Mortgage and Housing Corporation
Chairperson	Canada-Nova Scotia Offshore Petroleum Board
Member of the Board of Directors	Canada Post
Member	Canadian Cultural Property Export Review Board
Chairperson	Canadian Dairy Commission
Chief Executive Officer	Canadian Dairy Commission
Director	Canadian Energy Regulator
Federal Housing Advocate	Canadian Human Rights Commission
Chairperson	Canadian Human Rights Tribunal
Member	Canadian Human Rights Tribunal
Member	Canadian Institutes of Health Research
Director	Canadian Museum of History
Director	Canadian Race Relations Foundation
Temporary Member	Canadian Transportation Agency
Chairperson	Destination Canada
Director	Destination Canada
Director	Farm Credit Canada
Vice-Chairperson	Federal Public Sector Labour Relations and Employment Board
Director	Freshwater Fish Marketing Corporation
Member	Great Lakes Pilotage Authority Canada
Director (Federal)	Hamilton-Oshawa Port Authority
Member, Yukon	Historic Sites and Monuments Board of Canada
Governor	International Development Research Centre
Member (appointment to roster)	International Trade and International Investment Dispute Settlement Bodies
Chairperson	Laurentian Pilotage Authority Canada
Director	Marine Atlantic Inc.
Chairperson	Military Police Complaints Commission of Canada
Member	Military Police Complaints Commission of Canada
Member	National Arts Centre Corporation
Member	National Research Council Canada
Member	National Seniors Council
Commissioner and Director	Office of the Commissioner of Indigenous Languages
Superintendent	Office of the Superintendent of Financial Institutions Canada
Member	Payments in Lieu of Taxes Dispute Advisory Panel
Director	Public Sector Pension Investment Board of Canada
Member	Public Service Pension Advisory Committee
Chairperson	Standards Council of Canada
Registrar	Supreme Court of Canada
Director (Federal)	Toronto Port Authority
Chairperson and Member	Transportation Appeal Tribunal of Canada
Vice-Chairperson	Transportation Appeal Tribunal of Canada
Director (Federal)	Trois-Rivières Port Authority