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.
- SOR/2012-129, s. 5
- SOR/2018-69, s. 24(F)
- SOR/2021-46, s. 9(F)
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