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Food and Drug Regulations

Version of section C.05.011 from 2012-02-09 to 2024-05-28:

 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
  • SOR/2012-16, s. 8(F)

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