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

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by the Minister under Interim Order No. 2 before the day on which this section comes into force and that has not been revoked in whole before that day is deemed to be a COVID-19 medical device authorization or a COVID-19 drug authorization issued or reinstated under these Regulations.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.]