Food and Drug Regulations

C.04.007 (1) In this section, suitable for sale, in respect of a lot of a drug, means that the lot has been fabricated, packaged/labelled and tested in accordance with these Regulations and in a manner that is consistent with information provided to the Minister regarding the quality and safety of the drug.

(2) The Minister may, for the purpose of assessing whether a lot of a drug in dosage form is suitable for sale, request that the following persons provide the Minister with any information, samples of the drug or its active ingredients, or material to be used to test the samples:

• (a) a fabricator of the drug;

• (b) a packager/labeller of the drug;

• (c) an importer of the drug; or

• (d) the holder of the drug identification number.

(3) It is prohibited for a person who is requested to provide information, samples or material under subsection (2), and any other person whom the Minister notifies of the request, to sell drugs from the lot to which the request relates unless the Minister notifies the person that the lot is suitable for sale.