Food and Drug Regulations

C.10.009 (1) This section applies — but paragraph C.02.018(3)(c) and section C.02.019 do 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 that the Minister considers satisfactory, in the interests of the health of the consumer or purchaser, 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,

  • (i.1) the licensee undertakes periodic complete confirmatory testing, with a frequency that the Minister considers satisfactory, in the interests of the health of the consumer or purchaser, 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) The licensee shall possess or have immediate access to the specifications for the designated drug until at least the latest expiration date of the designated drug.

(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(6) [Repealed, SOR/2026-96, s. 20]