Food and Drug Regulations (C.R.C., c. 870)

C.02.019. (1) Subject to subsections (3) and (4), in the case of a packager/labeller, distributor referred to in paragraph C.01A.003(b) or importer, the testing referred to in section C.02.018 shall be performed on a sample taken

• (a) after receipt of each lot or batch of the drug on the premises in Canada of the packager/labeller, distributor referred to in paragraph C.01A.003(b) or importer of the drug; or

• (b) subject to subsection (2), before receipt of each lot or batch of the drug on the premises described in paragraph (a), if

  • (i) the packager/labeller, distributor referred to in paragraph C.01A.003(b) or importer

    • (A) has evidence satisfactory to the Director to demonstrate that drugs sold to him by the vendor of that lot or batch of the drug are consistently manufactured in accordance with and consistently comply with the specifications for those drugs, and

    • (B) undertakes periodic complete confirmatory testing with a frequency satisfactory to the Director, and

  • (ii) the drug has not been transported or stored under conditions that may affect its compliance with the specifications for that drug.

(2) Where the packager/labeller, distributor referred to in paragraph C.01A.003(b) or importer of a drug receives a lot or batch of the drug on their premises in Canada, and the useful life of the drug is more than 30 days, the lot or batch shall be tested for identity, and the packager/labeller shall confirm the identity after the lot or batch is packaged/labelled.

(3) The distributor referred to in paragraph C.01A.003(b) of a drug that is fabricated, packaged/labelled and tested in Canada by a person who holds an establishment licence that authorizes those activities is not required to comply with the requirements of subsections (1) and (2) in respect of that drug.

(4) If a drug is fabricated, packaged/labelled and tested in an MRA country at a recognized building, the distributor referred to in paragraph C.01A.003(b) or importer of that drug is not required to comply with the requirements of subsections (1) and (2) in respect of that drug if

• (a) the address of the building is set out in that person’s establishment licence; and

• (b) that person retains a copy of the batch certificate for each lot or batch of the drug received by that person.

C.02.020. (1) Every fabricator, packager/labeller, distributor referred to in paragraph C.01A.003(b) and importer shall maintain on their premises in Canada, for each drug sold,

• (a) master production documents for the drug;

• (b) evidence that each lot or batch of the drug has been fabricated, packaged/labelled, tested and stored in accordance with the procedures described in the master production documents;

• (c) evidence that the conditions under which the drug was fabricated, packaged/labelled, tested and stored are in compliance with the requirements of this Division;

• (d) evidence establishing the period of time during which the drug in the container in which it is sold will meet the specifications for that drug; and

• (e) adequate evidence of the testing referred to in section C.02.018.

(2) Every distributor referred to in paragraph C.01A.003(b) and importer shall make available to the Director, on request, the results of testing performed on raw materials and packaging/labelling material for each lot or batch of a drug sold.

(3) Every fabricator shall maintain on his premises

• (a) the written specifications for the raw material; and

• (b) adequate evidence of the testing of the raw materials referred to in section C.02.009.

(4) Every person who packages a drug shall maintain on his premises

• (a) the written specifications for the packaging material; and

• (b) adequate evidence of the packaging material examination or testing referred to in section C.02.016.

(5) Every fabricator shall maintain on their premises in Canada

• (a) detailed plans and specifications of each building in Canada at which they fabricate, package/label or test; and

• (b) a description of the design and construction of those buildings.

(6) Every fabricator, packager/labeller and tester shall maintain on their premises in Canada details of the personnel employed to supervise the fabrication, packaging/labelling and testing, including each person’s title, responsibilities, qualifications, experience and training.