Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (SOR/2022-18)

PART 3General

Marginal note: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.

• Marginal note: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 4Other Clinical Trials

Marginal note: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.

• Marginal note: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.

• Marginal note: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.

Marginal note: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.

• Marginal note: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.

Marginal note: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.

• Marginal note: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.

• Marginal note:Definitions

  (3) The following definitions apply in this section.

  clinical trial

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

  natural health product

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

Marginal note: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 that conducts the testing of the device — is, in respect of the testing, exempt from section 3.1 of the Act.

• Marginal note: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.

Marginal note: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.

• Marginal note:Reinstatement

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

• Marginal note: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.

• Marginal note:Partial suspensions or revocations

  (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 5Transitional Provisions

Marginal note:Definition of Interim Order No. 2

42 In sections 43 to 52, Interim Order No. 2 means the Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19, made by the Minister on May 3, 2021, and published in Part I of the Canada Gazette on May 22, 2021.

Marginal note: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. 2 before the day on which this section comes into force 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 these Regulations.

Marginal note: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. 2 before the day on which this section comes into force and that 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 these Regulations.

Marginal note:Approval — research ethics board

45 Any approval of a research ethics board that was obtained by a holder of a COVID-19 medical device authorization or a holder of a COVID-19 drug authorization under Interim Order No. 2 before the day on which this section comes into force 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 these Regulations.

Marginal note: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. 2 before the day on which this section comes into force are deemed to be terms and conditions imposed on the COVID-19 medical device authorization or the COVID-19 drug authorization under these Regulations.

Marginal note: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. 2 before the day on which this section comes into force 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 these Regulations.

Marginal note: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. 2 before the day on which this section comes into force and that 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 these Regulations.

Marginal note: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. 2 before the day on which this section comes into force and that 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 these Regulations.

Marginal note:Request — additional information and material

50 A request for additional information or material, including samples, that was made by the Minister under Interim Order No. 2 before the day on which this section comes into force is deemed to be a request for additional information or material under these Regulations.

Marginal note:Discontinuance

51 A notice of discontinuance provided to the Minister, or information in respect of discontinuance provided in writing to a qualified investigator, by the holder of a COVID-19 medical device authorization or a COVID-19 drug authorization under Interim Order No. 2 before the day on which this section comes into force is deemed to be a notice of discontinuance or information provided under these Regulations.

Marginal note: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. 2 before the day on which this section comes into force and that 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 these Regulations.

PART 6Consequential Amendments, Related Amendments and Coming into Force

Consequential Amendments

Certificate of Supplementary Protection Regulations

53 [Amendments]

Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages)

54 [Amendments]

Related Amendments

Food and Drug Regulations

55 [Amendments]

Natural Health Products Regulations

56 [Amendments]

Coming into Force

Marginal note:Registration

• Footnote ^*57 (1) Subject to subsection (2), these Regulations come into force on the day on which they are registered.

• Marginal note:Cessation of effect of interim order

  (2) Sections 1 to 53 come into force on the day following the day on which the Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19, made by the Minister on May 3, 2021, and published in the Part I of the Canada Gazette on May 22, 2021, ceases to have effect.

• Return to footnote ^*[Note: Sections 1 to 53 in force February 27, 2022.]