Government of Canada / Gouvernement du Canada
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Food and Drug Regulations

Version of section C.03.312 from 2018-04-04 to 2021-03-30:

 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.

  • SOR/2012-129, s. 5
  • SOR/2018-69, s. 24(F)

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