Food and Drug Regulations

C.05.008 (1) Subject to subsections (4) and (5), when the sale or importation of a drug is authorized under this Division and the sponsor proposes to make an amendment referred to in subsection (2), the sponsor may sell or import the drug for the purposes of the clinical trial in accordance with the amended authorization, if the following conditions are met:

• (a) the sponsor has submitted to the Minister an application for amendment in accordance with subsection (3);

• (b) the Minister does not, within 30 days after the date of receipt of the application for amendment, send to the sponsor a notice in respect of the drug indicating that the sponsor may not sell or import the drug in accordance with the amendment for any of the following reasons, namely,

  • (i) that the information and documents in respect of the application for amendment

    • (A) were not provided in accordance with these Regulations, or

    • (B) are insufficient to enable the Minister to assess the safety and risks of the drug or the clinical trial, or

  • (ii) that based on an assessment of the application for amendment, an assessment of any information submitted under section C.05.009 or a review of any other information, the Minister has reasonable grounds to believe that

    • (A) the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person,

    • (B) the clinical trial is contrary to the best interests of a clinical trial subject, or

    • (C) the objectives of the clinical trial will not be achieved;

• (c) before the sale or importation of the drug, the sponsor submits to the Minister

  • (i) for each clinical trial site, the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of the research ethics board that approved any amended protocol submitted under paragraph (3)(a) or approved any amended statement submitted under paragraph (3)(c), and

  • (ii) the name, address and telephone number and, if applicable, the facsimile number and electronic mail address of any research ethics board that has previously refused to approve any amendment to the protocol, its reasons for doing so and the date on which the refusal was given;

• (d) before the sale or importation of the drug, the sponsor maintains records concerning

  • (i) the information referred to in paragraph C.05.005(h), and

  • (ii) the information referred to in subparagraph C.05.005(c)(ix), if any of that information has changed since it was submitted;

• (e) before the sale or importation of the drug in accordance with the amended authorization, the sponsor ceases to sell or import the drug in accordance with the existing authorization; and

• (f) the sponsor conducts the clinical trial in accordance with the amended authorization.

(2) For the purposes of subsection (1), amendments are

• (a) amendments to the protocol that affect the selection, monitoring or dismissal of a clinical trial subject;

• (b) amendments to the protocol that affect the evaluation of the clinical efficacy of the drug;

• (c) amendments to the protocol that alter the risk to the health of a clinical trial subject;

• (d) amendments to the protocol that affect the safety evaluation of the drug;

• (e) amendments to the protocol that extend the duration of the clinical trial; and

• (f) amendments to the chemistry and manufacturing information that may affect the safety or quality of the drug.

(3) The application for amendment referred to in subsection (1) shall contain a reference to the application submitted under section C.05.005 and shall contain the following documents and information:

• (a) if the application is in respect of an amendment referred to in any of paragraphs (2)(a) to (e), a copy of the amended protocol that indicates the amendment, a copy of the protocol submitted under paragraph C.05.005(a), and the rationale for the amendment;

• (b) if the application is in respect of an amendment referred to in paragraph (2)(e), a copy of the amended investigator’s brochure or an addendum to the investigator’s brochure that indicates the new information, including supporting toxicological studies and clinical trial safety data;

• (c) if the application is in respect of an amendment referred to in any of paragraphs (2)(a) to (f) and, as a result of that amendment, it is necessary to amend the statement referred to in paragraph C.05.005(b), a copy of the amended statement that indicates the new information; and

• (d) if the application is in respect of an amendment referred to in paragraph (2)(f), a copy of the amended chemistry and manufacturing information that indicates the amendment, and the rationale for that amendment.

(4) If the sponsor is required to immediately make one or more of the amendments referred to in subsection (2) because the clinical trial or the use of the drug for the purposes of the clinical trial endangers the health of a clinical trial subject or other person, the sponsor may immediately make the amendment and shall provide the Minister with the information referred to in subsection (3) within 15 days after the date of the amendment.

(5) A sponsor may not sell or import a drug for the purposes of a clinical trial

• (a) during the period of any suspension made under section C.05.016 or C.05.017; or

• (b) after a cancellation made under section C.05.016 or C.05.017.