Canada Gazette, Part I, Volume 154, Number 23: GOVERNMENT NOTICES

June 6, 2020

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Interim Order Modifying the Operation of the Heavy-duty Vehicle and Engine Greenhouse Gas Emission Regulations (Trailer Standards)

Whereas certain provisions of part 1037 of title 40 of the United States Code of Federal Regulations correspond to certain provisions of the Heavy-duty Vehicle and Engine Greenhouse Gas Emission Regulationsfootnote a;

And whereas certain provisions of those Heavy-duty Vehicle and Engine Greenhouse Gas Emission Regulations footnote a are inconsistent with Title 40, chapter I, subchapter U, part 1037, of the Code of Federal Regulations because of the stay of the operation of the emission provisions for trailers — namely, the greenhouse gas emission standards for trailers, at 40 Code of Federal Regulations section 1037.107, and the other provisions in 40 Code of Federal Regulations Part 1037 that are contained in the Final Rule of United States’ Environmental Protection Agency, published in October 2016 in volume 81 of the Federal Register of the United States, at page 73,478, to the extent that they apply to trailers or trailer manufacturers — that was granted by the U.S. Court of Appeals for the District of Columbia Circuit, on October 27, 2017, in the case of Truck Trailer Manufacturers Association Inc. v the United States Environmental Protection Agency, and al. (Case No. 16-1430, consolidated with No. 16-1447);

Therefore, the Minister of the Environment, pursuant to subsection 163(1) of the Canadian Environmental Protection Act, 1999footnote b, makes the annexed Interim Order Modifying the Operation of the Heavy-duty Vehicle and Engine Greenhouse Gas Emission Regulations (Trailer Standards).

Gatineau, May 18, 2020

Jonathan Wilkinson
Minister of the Environment

Interim Order Modifying the Operation of the Heavy-duty Vehicle and Engine Greenhouse Gas Emission Regulations (Trailer Standards)

January 1, 2020

1 Despite any provision of the Heavy-duty Vehicle and Engine Greenhouse Gas Emission Regulations, those Regulations do not apply to trailers on and after January 1, 2020.

EXPLANATORY NOTE

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

The Interim Order Modifying the Operation of the Heavy-duty Vehicle and Engine Greenhouse Gas Emission Regulations (Trailer Standards) was made by the Minister of the Environment on May 18, 2020. The Interim Order applies to trailers only and temporarily suspends the application of the trailer provisions of the Heavy-duty Vehicle and Engine Greenhouse Gas Emission Regulations. Upon approval by the Governor in Council, and in accordance with subsection 163(5) of the Canadian Environmental Protection Act, 1999, the Interim Order will cease to have effect one year after the order is made, or the day it is repealed, or the day on which the regulation is amended or repealed to give effect to the order, whichever is earlier.

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Ministerial Condition No. 20222

Ministerial condition

(Paragraph 84(1)(a) of the Canadian Environmental Protection Act, 1999)

Whereas the Minister of the Environment and the Minister of Health (the ministers) have assessed information pertaining to the substance sulfonic acids, branched alkane hydroxy and branched alkene, sodium salts, Confidential Substance Identity Number 19435-3;

And whereas the ministers suspect that the substance is toxic or capable of becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999 (the Act),

The Minister of the Environment, pursuant to paragraph 84(1)(a) of the Act, hereby permits the manufacture or import of the substance in accordance with the conditions of the following annex.

Nancy Hamzawi
Assistant Deputy Minister
Science and Technology Branch

On behalf of the Minister of the Environment

ANNEX

Conditions

(Paragraph 84(1)(a) of the Canadian Environmental Protection Act, 1999)

1. The following definitions apply in these ministerial conditions:

2. The notifier may manufacture or import the substance in accordance with the present ministerial conditions.

Restrictions

3. The notifier may import the substance only to use it to inject in petroleum reservoirs for oil production operations.

4. The notifier shall transfer the physical possession or control of the substance only to a person who agrees to use it in accordance with section 3.

5. At least 120 days prior to the manufacture of the substance in Canada, the notifier shall inform the Minister of the Environment, in writing, and provide the following information:

Disposal of the substance

6. The notifier or the person to whom the substance has been transferred, must collect any waste in their physical possession or under their control and destroy or dispose of it in the following manner:

Environmental release

7. Where any release of the substance or waste to the environment occurs, other than use of the substance in accordance with section 3, the person who has the physical possession or control of the substance or waste shall immediately take all measures necessary to prevent any further release, and to limit the dispersion of any release. Furthermore, the person shall, as soon as possible in the circumstances, inform the Minister of the Environment by contacting an enforcement officer designated under the Canadian Environmental Protection Act, 1999.

Other requirements

8. The notifier shall inform any person to whom they transfer the physical possession or control of the substance or the waste, in writing, of the terms of the present ministerial conditions. The notifier shall obtain, prior to the first transfer of the substance or waste, written confirmation from this person that they were informed of the terms of the present ministerial conditions and agree to comply with sections 3, 6 and 7 of the present ministerial conditions.

Record-keeping requirements

9. (1) The notifier shall maintain electronic or paper records, with any documentation supporting the validity of the information contained in these records, indicating

(2) The notifier shall maintain the electronic or paper records mentioned in subsection (1) at their principal place of business in Canada, or at the principal place of business of their representative in Canada, for a period of at least five years after they are made.

Coming into force

10. The present ministerial conditions come into force on April 27, 2020.

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Ministerial Condition No. 20249

Ministerial condition

(Paragraph 84(1)(a) of the Canadian Environmental Protection Act, 1999)

Whereas the Minister of the Environment and the Minister of Health (the ministers) have assessed information pertaining to the substance amides, tall-oil fatty, N-[3-(dimethylamino)propyl], Chemical Abstracts Service Registry Number 68650-79-3;

And whereas the ministers suspect that the substance is toxic or capable of becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999 (the Act),

The Minister of the Environment, pursuant to paragraph 84(1)(a) of the Act, hereby permits the manufacture or import of the substance in accordance with the conditions of the following annex.

Nancy Hamzawi
Assistant Deputy
Minister Science and Technology Branch

On behalf of the Minister of the Environment

ANNEX

Conditions

(Paragraph 84(1)(a) of the Canadian Environmental Protection Act, 1999)

1. The following definitions apply in these ministerial conditions:

2. The notifier may manufacture or import the substance in accordance with the present ministerial conditions.

Restrictions

3. The notifier may import the substance only to incorporate it as a component of asphalt or bitumen emulsions.

4. The notifier shall transfer the physical possession or control of the substance only to a person who agrees to use it in accordance with section 3.

5. At least 120 days prior to the manufacture of the substance in Canada, the notifier shall inform the Minister of the Environment, in writing, and provide the following information:

Disposal of the substance

6. The notifier or the person to whom the substance has been transferred must

Environmental release

7. Where any release of the substance or waste to the environment occurs, the person who has the physical possession or control of the substance or waste shall immediately take all measures necessary to prevent any further release, and to limit the dispersion of any release. Furthermore, the person shall, as soon as possible in the circumstances, inform the Minister of the Environment by contacting an enforcement officer designated under the Canadian Environmental Protection Act, 1999.

Other requirements

8. The notifier shall inform any person to whom they transfer the physical possession or control of the substance, waste or containers or transportation vessels that contained the substance, in writing, of the terms of the present ministerial conditions. The notifier shall obtain, prior to the first transfer of the substance, waste or containers or transportation vessels, written confirmation from this person that they were informed of the terms of the present ministerial conditions and agree to comply with sections 3, 6 and 7 of the present ministerial conditions.

Record-keeping requirements

9. (1) The notifier shall maintain electronic or paper records, with any documentation supporting the validity of the information contained in these records, indicating

(2) The notifier shall maintain the electronic or paper records mentioned in subsection (1) at their principal place of business in Canada, or at the principal place of business of their representative in Canada, for a period of at least five years after they are made.

Coming into force

10. The present ministerial conditions come into force on April 8, 2020.

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Notice with respect to the availability of an equivalency agreement

Pursuant to subsection 10(4) of the Canadian Environmental Protection Act, 1999, notice is hereby given that the Minister of the Environment makes available, before it is entered into, the Agreement on the Equivalency of Federal and Alberta Regulations Respecting the Release of Methane from the Oil and Gas Sector in Alberta, 2020.

The proposed agreement is available as of June 6, 2020, on the Environmental Registry of the Department of the Environment.

Any person may, within 60 days after the publication of this notice, file with the Minister comments or a notice of objection. All such comments and notices must cite the present notice and its date of publication in the Canada Gazette, Part I, and be sent to the following contact person.

Contact

Magda Little
Director
Oil, Gas and Alternative Energy Division
Department of the Environment
351 Saint-Joseph Boulevard
Gatineau, Quebec
K1A 0H3
Email: ec.methane-methane.ec@canada.ca

DEPARTMENT OF HEALTH

FOOD AND DRUGS ACT

Interim Order 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 Actfootnote d, makes the annexed Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19.

Ottawa, May 23, 2020

Patricia Hajdu
Minister of Health

Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19

Interpretation

Definitions

1 The following definitions apply in this Interim Order.

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 and sale of a COVID-19 medical device that is to be tested in a clinical trial and 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.

Non-application — COVID-19 drug

(3) The following regulations do not apply to the importation and sale of a COVID-19 drug that is to be tested in a clinical trial and 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:

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:

Class II devices

(3) Despite subsection (2), if the application for the authorization is in respect of a Class II COVID-19 medical 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:

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

Suspension

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

Reinstatement

(2) The Minister must reinstate a COVID-19 medical device authorization if the holder of the authorization provides to the Minister, in the time, form and manner specified by the Minister, information or material that demonstrates that the situation giving rise to the suspension did not exist or has been corrected.

Additional information and material

10 (1) The Minister may request an applicant for a COVID-19 medical device authorization or a holder of such an authorization to 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 provide 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

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 provided 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:

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 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 and that include the information and material referred to in subsection 4(2).

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, sold or tested 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:

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

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:

Information — after recall

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

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:

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

Issuance

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

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

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

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, file 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

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

Suspension

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

Reinstatement

(2) The Minister must reinstate a COVID-19 drug authorization if the holder of the authorization provides to the Minister, in the time, form and manner specified by the Minister, information or material that demonstrates that the situation giving rise to the suspension did not exist or has been corrected.

Additional information and material

30 (1) The Minister may request an applicant for a COVID-19 drug authorization or a holder of such an authorization to 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 provide 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

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 provided 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:

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:

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:

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:

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

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

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

Definitions

(3) The following definitions apply in this section.

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

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

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.

EXPLANATORY NOTE

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

Proposal

The Minister may make an interim order under subsection 30.1(1) of the Food and Drugs Act (the Act) if the Minister believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment. The Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 (the Interim Order), made by the Minister of Health on May 23, 2020, creates an agile framework that introduces efficiencies in the conduct of and access to Canadian clinical trials for COVID-19-related drugs and medical devices. The Order in Council enables the operation of the Interim Order under subsection 30.1(2) of the Act, allowing the Interim Order to remain in effect for up to one year after it is made.

The Interim Order provides an optional authorization and implementation pathway for clinical trials of pharmaceutical drugs, biologic drugs (including blood and blood components), and Class II, III and IV medical devices involving human subjects in relation to the diagnosis, treatment, mitigation, or prevention of COVID-19 or COVID-19 complications. The Interim Order regulates both the importation and sale of drugs and devices for the purposes of clinical trials in relation to COVID-19, and the conduct of those clinical trials. As an alternative to the requirements in the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR), the sponsors of clinical trials for COVID-19-related drugs and medical devices may opt to proceed through the pathway created in the Interim Order. The trials may assess existing, marketed products in Canada for use as COVID-19-related therapies, or they may assess new COVID-19-related therapies currently under development.

The framework will facilitate the launch of COVID-19-related clinical trials by reducing the administrative burden relating to trial-related authorizations and implementation, while still upholding the requirements necessary for the health and safety of clinical trial subjects and the validity of trial data. As the framework covers both drugs and medical devices, it uses the common term “clinical trials,” rather than the MDR’s term “investigational testing.”

Objective

The objective of the proposal is to mitigate and prevent infections caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and to protect the health and safety of Canadians in relation to COVID-19 by enabling a framework that introduces efficiencies in the conduct of and access to Canadian clinical trials for drugs and medical devices used in the diagnosis, treatment, mitigation, or prevention of COVID-19 or COVID-19 complications.

Background

COVID-19 is the infectious respiratory disease caused by the most recently discovered coronavirus, SARS-CoV-2. The outbreak of COVID-19 began in December 2019 and has since spread around the world. COVID-19 infection may cause respiratory symptoms, fever, cough, shortness of breath, and breathing difficulties. In more severe cases, COVID-19 infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and death.

The World Health Organization declared a global pandemic related to COVID-19 on March 11, 2020. Globally, there are now more than 2.4 million cases in over 200 countries where over 160 000 people have died. The number of confirmed cases in Canada as of April 19, 2020, has exceeded 34 000, with over 1 500 deaths; however, these numbers continue to increase.

There is currently no specific vaccine or treatment for COVID-19 authorized in Canada, but there is active research and development underway around the world to develop therapies for it. The last stage of research and development is human clinical trials, which assess a therapy’s safety and effectiveness. The evidence collected through trials is crucial for demonstrating that the therapy is effective in diagnosing, treating, mitigating, or preventing the condition, and that its benefits exceed its risks.

Through Division 5 in Part C of the FDR and Part 3 of the MDR, Health Canada regulates the importation and sale of drugs and devices for the purpose of clinical trials. Health Canada also regulates the clinical trials of natural health products through Part 4 of the Natural Health Products Regulations (NHPR), radiopharmaceutical drugs through Division 5 in Part C of the FDR, and positron-emitting radiopharmaceuticals through Division 3 in Part C of the FDR, but the clinical trials for those products are not included in the Interim Order, as the priority therapies are pharmaceutical drugs, biologic drugs (including blood and blood components), and medical devices. Class I medical devices are also excluded from the Interim Order.

Health Canada permits the use 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 and requires that a research ethics board has reviewed and approved the trial before it is initiated 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.

These steps and others involved in trials take time, as conducting clinical trials is a complex undertaking, particularly if the trials take place at multiple sites. Administrative steps can result in delays in implementing clinical trials, with a resulting delay in the therapy potentially becoming widely available to treat patients. The possibility of such delays in the availability of therapies for COVID-19 and related conditions is of concern given the widespread impacts of COVID-19 in Canada.

Implications

Flexible pathway

The pathway in the Interim Order has been designed to better facilitate clinical trials during a public health emergency. It can support the launch of clinical trials by increasing efficiencies and reducing the administrative burden of certain requirements; it also makes it easier to set up and run multi-site trials, thereby facilitating larger trials that are more likely to provide the evidence needed to confirm a therapy’s effects.

The Interim Order increases flexibility by, for example, expanding the scope of the definition of qualified investigator for clinical trials for drugs to permit for additional licensed health care professionals, such as nurse practitioners, to fill that role. This flexibility is anticipated to help facilitate multi-site trials as well as trials in locations, such as remote Northern communities, where there is a scarcity of physicians available to oversee them. The Interim Order also enables two alternate means of obtaining informed consent when prospective clinical trial subjects are unable to consent in person or in writing. The first permits remote, written informed consent of a prospective subject when they are unable to be in the same location as the qualified investigator. When a prospective subject cannot provide written informed consent, the second means permits non-written informed consent. These measures will support multi-site trials, including those with sites in remote locations, where the qualified investigator and prospective subject are in different locations and consent may be obtained, for instance, via videoconference. These measures will also reduce barriers to the provision of consent given restrictions currently in place due to COVID-19; for instance, persons in isolation in most hospitals are not allowed access to paper due to infection control.

The Interim Order further reduces the burden of certain requirements involving communication with Health Canada regarding changes that occur over the course of a trial. This includes removing the requirement for notification for lower-risk changes, and requiring amendment applications only for significant changes with potentially higher risks. The Minister of Health will also have the ability to partially suspend or cancel a trial, which, for example, would allow her to suspend one arm, or treatment group, of a randomized trial if needed, while allowing the rest of the trial to continue so that other patients can still continue to receive a promising therapy. This ability will offer increased flexibility for the type of innovative trial designs being pursued for COVID-19 drugs and devices, such as those coordinated through the World Health Organization.

Oversight of clinical trials

As the health and safety of clinical trial subjects remain as important as ever, the Interim Order provides the Minister of Health with certain abilities to oversee and intervene in clinical trials, as needed, in the best interest of clinical trial subjects. These abilities include imposing terms and conditions on clinical trial authorizations, which would be applied on a case-by-case basis to address uncertainties and mitigate risks. Terms and conditions could include requiring more frequent safety reporting; monitoring specific populations because of potential increased risk (e.g. children); or providing additional information to characterize and mitigate newly identified risks. Another oversight ability permits the Minister to request additional information in relation to a clinical trial application or authorization that is necessary to enable the Minister to determine whether to issue, amend, suspend or cancel (in whole or in part) the authorization.

Regarding other requirements for clinical trials, the pathway in this Interim Order has several equivalent requirements to those in the FDR and the MDR. These include requirements for incident reporting, labelling, record keeping, good clinical practices, and good manufacturing practices. However, the Interim Order has certain reduced application, labelling, and record-keeping requirements for marketed drugs that are already authorized in Canada for other uses and that are used in COVID-19-related clinical trials within the standard of medical practice.

There are no unintended gender-based analysis plus implications for this Interim Order. As COVID-19 more seriously affects individuals who are aged, or have compromised immune systems, the Interim Order is expected to assist these populations in accessing therapies related to COVID-19.

As with all clinical trials conducted in Canada, Health Canada will monitor the safety of the drugs and devices used under the Interim Order and will take immediate action, including the suspension or cancellation of authorizations, if required to protect the health and safety of Canadians.

Status quo for clinical trials regulated under the FDR, the MDR and the NHPR

The Interim Order is enabled by powers in the Act that were added through the Budget Implementation Act, 2019, No. 1 (“BIA 2019”) and that, among other things, permit the Minister of Health to regulate the conduct of clinical trials. This power derives from a prohibition against conducting a clinical trial without authorization and the supporting authorities to make regulations respecting that conduct. An Order in Council made on May 22, 2020, brought these provisions into force. The prohibition respecting the conduct of clinical trials applies to clinical trials approved through the Interim Order; clinical trials that have previously been approved through the existing regulatory frameworks in the FDR, the MDR and the NHPR; and upcoming clinical trials that will continue to be approved through the existing regulatory frameworks.

In the case of clinical trials related to COVID-19, the Interim Order provides an optional flexible pathway for the issuance of authorizations to conduct those clinical trials and to import and sell drugs and devices for the purpose of those clinical trials, and it exempts these trials from the application of the current regulatory frameworks.

In the case of those who hold authorizations under the existing regulatory frameworks, the Interim Order contains provisions that provide for the non-application of the prohibition and allow for the maintenance of these regulatory pathways. Existing authorization holders are deemed to be holders of an authorization to conduct a clinical trial as a result of transition provisions that are contained in the BIA 2019. These holders will continue to hold their current authorizations under the regulatory framework under which they were approved. If an authorization under the existing regulatory framework is suspended or revoked in whole or in part, the authorization for conduct is suspended or revoked to the same extent. The result is to make the holding of this deemed authorization overall neutral in its effect.

With respect to upcoming clinical trials (which may include both COVID-19-related clinical trials and clinical trials not related to COVID-19 where the authorization holder has chosen to proceed under the existing regulatory frameworks rather than via the flexible pathway), the Interim Order exempts these clinical trials from the new prohibition and allows for the maintenance of the existing regulatory pathways for these trials so that they can begin in the same manner as existing clinical trials (i.e. with an authorization for sale of the drug or device for use in a clinical trial and a deemed authorization for conduct).

The Interim Order will be in effect for a period of one year from the date it is made. As a result, a Governor in Council regulation will need to be made within that year to continue exempting clinical trials authorized under the current regulatory frameworks from the new prohibition. These exemptions would remain in place until a more comprehensive clinical trial framework, which will be fully consulted on, is ready to be made to allow the new prohibition to apply more broadly.

Consultation

Many aspects of the Interim Order have leveraged elements from the forthcoming broader Clinical Trials Modernization Initiative, which have been discussed with stakeholders via Regulatory Innovation road shows, consultations and outreach. Health Canada has also held targeted consultation sessions to seek input on some of the concepts underlying the Interim Order from key stakeholders, including research ethics boards across Canada, provincial and territorial governments, industry associations in the drug, medical device and biotechnology sectors, the Canadian Institutes of Health Research, the Canadian Institute for Health Information, and the Canadian Cancer Trials Group at Queen’s University.

The Canadian Border Services Agency has been made aware that drugs and medical devices authorized under the Interim Order will be accompanied by a copy of the authorization to facilitate identification and importation at the border.

Contact

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

DEPARTMENT OF HEALTH

HAZARDOUS MATERIALS INFORMATION REVIEW ACT

Filing of claims for exemption

A supplier can file a claim for exemption under the Hazardous Materials Information Review Act (HMIRA) with Health Canada from having to disclose information, under the Hazardous Products Act (HPA) and the Hazardous Products Regulations (HPR), that they consider to be confidential business information (CBI) on a safety data sheet (SDS) or label associated with a hazardous product.

An employer can also file a claim for exemption under the HMIRA with Health Canada from having to disclose information, under the Canada Labour Code or the provisions of the Accord Act, that they consider to be CBI on an SDS or label associated with a hazardous product.

Notice is hereby given of the filing of claims for exemption under the HMIRA listed in the table below.

Lynn Berndt-Weis
Director
Workplace Hazardous Materials Bureau
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch

Claimant

Product Identifier

Subject of the Claim for Exemption

Registry Number

Nalco Canada ULC

EC5981A

C.i. of two ingredients

03357566

Baker Hughes Canada Company

WCW77 COMBINATION PRODUCT

C.i. of five ingredients

03357568

Afton Chemical Corporation

AvGuard™ SDA

C.i. of one ingredient

03357591

Nalco Canada ULC

NALCO EC6697A

C.i. of one ingredient

03357617

LANXESS Canada Co./Cie

XP 190521GA-1

C.i. of one ingredient

03357620

Nalco Canada ULC

SCAL06690A

C.i. of one ingredient

03357807

Luxfer MEL Technologies

SoluMag® HP

C.i. of four ingredients

03358272

Flotek Chemistry

NEC-10

C.i. of one ingredient

03358499

WANHUA CHEMICAL AMERICA CO., LTD.

Aquolin® 268

C.i. of one ingredient

03359475

Ingevity Corporation

Evotherm P25

C.i. and C. of two ingredients

03359706

Hexion Inc.

StructurFast® OS-518SA

C.i. and C. of three ingredients

03359713

Ingevity Corporation

Indulin 209 (Export Only)

C.i. of one ingredient

03360163

Ingevity Corporation

PERAL 600

C.i. of one ingredient

03360164

Baker Hughes Canada Company

FULLSWEET HSS1001

C.i. and C. of two ingredients
C.i. of one ingredient

03360489

Baker Hughes Canada Company

DMO3420 DEMULSIFIER

C.i. and C. of one ingredient
C. of two ingredients

03360923

Cambrian Solutions, a Maroon Group Company

Camsolv

C.i. and C. of seven ingredients

03360938

Canadian Energy Services LP

WRXSOL-NANO-POLY

C.i. and C. of four ingredients

03362696

Canadian Energy Services LP

PC-NANOSURF W

C.i. and C. of three ingredients

03363065

Canadian Energy Services LP

STIMWRX-NANOSURF

C.i. and C. of three ingredients

03363066

Baker Hughes Canada Company

TRETOLITE™ RBW7100 ANTIFOULANT

C.i. and C. of one ingredient
C. of one ingredient

03363108

Baker Hughes Canada Company

EXCALIBUR™ 7760 ADDITIVE

C.i. and C. of one ingredient

03363109

Baker Hughes Canada Company

LIFESPAN™ 3500 HEAVY OIL STABILIZER

C.i. and C. of one ingredient
C. of three ingredients

03363110

Univar Canada Ltd.

VANFROTH 350

C.i. and C. of three ingredients

03363305

Univar Canada Ltd.

VANFROTH 820

C.i. and C. of three ingredients

03363306

Univar Canada Ltd.

VANFROTH 702

C.i. and C. of two ingredients
C. of one ingredient

03363307

Allnex Canada Inc., c/o Goodmans, LLP

SETALUX® D A 160 SN

C.i. and C. of one ingredient

03364105

Hexion Inc.

Cascophen™ TL-3618HT

C.i. and C. of three ingredients

03364162

SUEZ Water Technologies & Solutions Canada

PROSWEET S1820

C.i. and C. of one ingredient

03365410

RAHN USA

GENOMER* 4622

C.i. and C. of one ingredient

03365456

Baker Hughes Canada Company

TOPGUARD™ 1195 NEUTRALIZER

C.i. and C. of one ingredient
C. of two ingredients

03366134

NPS Corporation

Universal Absorbent

C.i. of one ingredient

03366440

The Lubrizol Corporation

SOLSPERSE ™ 12000

C.i. of one ingredient

03366601

Honeywell Aerospace

Abrasive Powder 1

C.i. of one ingredient

03367203

Honeywell Aerospace

Cobalt Salt 1

C.i. of one ingredient

03367204

NextStream LLC

CATALYST A

C.i. and C. of two ingredients
C.i. of one ingredient

03367509

Baker Hughes Canada Company

RE33110RBW WATER CLARIFIER

C.i. of two ingredients

03368702

Baker Hughes Canada Company

RE33111RBW WATER CLARIFIER

C.i. of two ingredients

03368703

Baker Hughes Canada Company

SCW777 SCALE INHIBITOR

C.i. and C. of one ingredient

03368704

Baker Hughes Canada Company

M9900

C.i. and C. of one ingredient

03368705

Baker Hughes Canada Company

SUBSEA 723 SCALE INHIBITOR

C.i. of one ingredient

03368748

ChampionX Canada ULC

PMNP11111A

C.i. and C. of one ingredient

03368762

ChampionX Canada ULC

PMNP11115A

C.i. and C. of one ingredient

03369116

Univar Canada Ltd.

VANQUEST 100

C.i. and C. of five ingredients
C. of one ingredient

03369126

NextStream LLC

CATALYST B

C.i. of two ingredients

03367347

Note: C.i. = chemical identity and C. = concentration

DEPARTMENT OF INDUSTRY

OFFICE OF THE REGISTRAR GENERAL

Appointment

Instrument of Advice dated March 9, 2020

May 27, 2020

Diane Bélanger
Official Documents Registrar

DEPARTMENT OF INDUSTRY

OFFICE OF THE REGISTRAR GENERAL

Appointments

May 27, 2020

Diane Bélanger
Official Documents Registrar

PRIVY COUNCIL OFFICE

Appointment opportunities

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

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

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

Current opportunities

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

Position

Organization

Closing date

Member

Atlantic Pilotage Authority

  

Chairperson

Canada Council for the Arts

  

President and Chief Executive Officer

Canada Lands Company Limited

  

Member (Federal)

Canada–Newfoundland and Labrador Offshore Petroleum Board

  

Chief Executive Officer

Canadian Centre on Substance Abuse

  

President

Canadian Commercial Corporation

  

Chief Executive Officer

Canadian Energy Regulator

  

Commissioner (full-time),
Commissioner (part-time)

Canadian Energy Regulator

  

Director

Canadian Energy Regulator

  

Chairperson

Canadian International Trade Tribunal

  

Director

Canadian Museum for Human Rights

  

Permanent Member

Canadian Nuclear Safety Commission

  

Executive Director

Canadian Race Relations Foundation

  

Member (Alberta and Northwest Territories)

Canadian Radio-television and Telecommunications Commission

  

Member (Atlantic and Nunavut)

Canadian Radio-television and Telecommunications Commission

  

President

Canadian Space Agency

  

Temporary Member

Canadian Transportation Agency

  

President

Destination Canada

  

Director

Export Development Canada

  

Chairperson

Federal Public Sector Labour Relations and Employment Board

  

Vice-Chairperson

Federal Public Sector Labour Relations and Employment Board

  

Chairperson

Great Lakes Pilotage Authority Canada

  

Director (Federal)

Hamilton-Oshawa Port Authority

  

Members (appointment to roster)

International Trade and International Investment Dispute Settlement Bodies

  

Chairperson

Marine Atlantic Inc.

  

Director (Federal)

Nanaimo Port Authority

  

Secretary

National Battlefields Commission

  

Auditor General of Canada

Office of the Auditor General of Canada

  

Taxpayers’ Ombudsman

Office of the Taxpayers’ Ombudsman

  

Member

Payments in Lieu of Taxes Dispute Advisory Panel

  

Chairperson

Polar Knowledge Canada

  

Member

Polar Knowledge Canada

  

President

Polar Knowledge Canada

  

Director

Public Sector Pension Investment Board

  

President

Social Sciences and Humanities Research Council of Canada

  

Registrar

Supreme Court of Canada

  

Member

Transportation Appeal Tribunal of Canada

  

Vice-Chairperson

Transportation Appeal Tribunal of Canada

  

Member

Transportation Safety Board of Canada