Food and Drug Regulations

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.