Food and Drug Regulations

C.05.011 Despite any other provision of these Regulations respecting labelling, the sponsor shall ensure that the drug bears a label that sets out the following information in both official languages:

• (a) a statement indicating that the drug is an investigational drug to be used only by a qualified investigator;

• (b) the name, number or identifying mark of the drug;

• (c) the expiration date of the drug;

• (d) the recommended storage conditions for the drug;

• (e) the lot number of the drug;

• (f) the name and address of the sponsor;

• (g) the protocol code or identification; and

• (h) if the drug is a radiopharmaceutical as defined in section C.03.201, the information required by subparagraph C.03.202(1)(b)(vi).