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Food and Drug Regulations

Version of section C.02.012 from 2013-11-08 to 2024-05-28:

  •  (1) Every fabricator, packager/labeller, distributor referred to in section C.01A.003, importer and wholesaler of a drug shall maintain

    • (a) a system of control that permits complete and rapid recall of any lot or batch of the drug that is on the market; and

    • (b) a program of self-inspection.

  • (2) Every fabricator and packager/labeller and, subject to subsections (3) and (4), every distributor referred to in paragraph C.01A.003(b) and importer of a drug shall maintain a system to ensure that any lot or batch of the drug fabricated and packaged/labelled on premises other than their own is fabricated and packaged/labelled in accordance with the requirements of this Division.

  • (3) Subsection (2) does not apply to a distributor if the drug is fabricated, packaged/labelled and tested in Canada by a person who holds an establishment licence that authorizes those activities in respect of that drug.

  • (4) Subsection (2) does not apply to a distributor or importer if the drug is fabricated or packaged/labelled in an MRA country at a recognized building and both of the following requirements 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 drug that they receive.

  • SOR/82-524, s. 3
  • SOR/97-12, s. 13
  • SOR/2000-120, s. 9
  • SOR/2002-368, s. 9
  • SOR/2013-74, s. 8

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