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 a of the Food and Drugs ActFootnote b, 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

Table of contents

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 utili‐ sé 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

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:

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 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:

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 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,

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:

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:

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 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

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, 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

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 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

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:

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.

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

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.

Part 5

Transitional Provisions and Repeal

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.

Footnotes

Footnote b

S.C. 2004, c. 15, s. 66

Return to footnote a referrer

Footnote a

R.S., c. F-27

Return to footnote b referrer

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