Food and Drug Regulations

C.10.009 (1) Section C.02.019 does not apply to a person who holds an establishment licence in respect of a designated drug that they import under section C.10.006.

(2) The licensee shall perform the finished product testing on a sample of the designated drug that is taken either

• (a) after receipt of each lot or batch of the designated drug on their premises in Canada; or

• (b) before receipt of each lot or batch of the designated drug on their premises in Canada if the following conditions are met:

  • (i) the licensee has evidence satisfactory to the Minister to demonstrate that lots or batches of the designated drug sold to them by the vendor of the lot or batch are consistently manufactured in accordance with and consistently comply with the specifications for that drug, and

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

(3) In subsection (2), a reference to specifications is a reference to the specifications with which the designated drug is required to comply within the jurisdiction of the foreign regulatory authority referred to in paragraph C.10.006(1)(b).

(4) If the licensee receives on their premises in Canada a lot or batch of a designated drug whose useful life is more than 30 days, they shall visually inspect the lot or batch to confirm the identity of the product.

(5) Subsections (2) and (4) do not apply to the licensee if the designated drug is fabricated, packaged/labelled and tested in an MRA country at a recognized building and the following conditions are met:

• (a) the address of the building is set out in their establishment licence; and

• (b) they retain a copy of the batch certificate for each lot or batch of the designated drug that they receive for at least one year after the expiration date of the lot or batch.

(6) In this section, specifications has the same meaning as in section C.02.002.