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38 (1) A person that is authorized under Division 3 of Part C of the Food and Drug Regulations to sell or import a positron-emitting radiopharmaceutical for the purposes of a study — and any other person that conducts the study — is, in respect of the study, exempt from section 3.1 of the Act.

(2) For greater certainty, the exemption does not apply

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  (b) in respect of the conduct of the study at a study site, if the authorization to sell or import the radiopharmaceutical is suspended or cancelled in respect of that site.

(2) The application must contain sufficient information and material to enable the Minister to determine whether to issue the authorization and must include the following:

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  (h) any toxicological effects of the drug in any animal species tested under a single dose study, a repeated dose study or a special study;

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  (i) any results of carcinogenicity studies in any animal species tested in respect of the drug;

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  (j) any results of clinical pharmacokinetic studies of the drug;