Food and Drug Regulations (C.R.C., c. 870)

C.03.308. If the information submitted under section C.03.307 is insufficient to enable the Minister to determine whether the sale or importation of the study drug should be authorized, the Minister may, by notice in writing, request the sponsor to provide any additional information that is necessary to make the determination and that is relevant to the study drug, the study or the protocol, by the date specified in the notice.

C.03.309. After examining the application and any additional information, the Minister shall authorize the sponsor to sell or import the study drug if she or he determines that the application complies with the requirements of section C.03.307, and shall send a notice of that decision to the sponsor that specifies the study sites in respect of which the sale or importation are authorized.

C.03.310. The sponsor shall notify the Minister in writing of the day on which the sale or importation of the study drug is intended to start in respect of each study site, not later than 15 days before that day.

C.03.311. A sponsor shall ensure that each study is conducted in accordance with good clinical practices and that

• (a) the study is scientifically sound and clearly described in its protocol;

• (b) the study is conducted, and the study drug is used, in accordance with the protocol and with these Regulations;

• (c) systems and procedures are implemented that assure the quality of every aspect of the study;

• (d) at each study site, there is only one qualified investigator;

• (e) at each study site, medical care and medical decisions, in respect of the study, are under the supervision of the qualified investigator;

• (f) each individual who is involved in the conduct of the study is qualified by their education, training and experience to perform their respective tasks;

• (g) before a study subject participates in the study, a copy of their signed consent form is included in the records for the study;

• (h) the requirements respecting information and records set out in section C.03.315 are met; and

• (i) the study drug is manufactured, handled and stored in accordance with Division 2, other than sections C.02.019, C.02.025 and C.02.026.

C.03.312. Despite any other provision of these Regulations respecting labelling, the sponsor shall ensure that the study drug

• (a) bears an inner label that sets out both of the following:

  • (i) the unique batch number for the study drug, and

  • (ii) the radiation warning symbol set out in Schedule 3 to the Radiation Protection Regulations and the words “RAYONNEMENT — DANGER — RADIATION”; and

• (b) is accompanied by a package insert that sets out all of the following information:

  • (i) a statement that indicates that the study drug is to be used only under the supervision of a qualified investigator,

  • (ii) the chemical or generic name of the active ingredients in the study drug,

  • (iii) the name and civic address of the manufacturer,

  • (iv) the name and civic address of the sponsor,

  • (v) the code or other identification of the protocol,

  • (vi) the warnings and precautions in respect of the use of the study drug, and

  • (vii) a list of the possible adverse reactions that are associated with the use of the study drug.