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).
- SOR/2001-203, s. 4.
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