Government of Canada / Gouvernement du Canada
Symbol of the Government of Canada

Search

Food and Drug Regulations

Version of section C.01A.004 from 2022-12-08 to 2024-04-01:

  •  (1) Subject to subsection (2), no person shall, except in accordance with an establishment licence,

    • (a) fabricate, package/label or import a drug;

    • (b) perform the tests, including examinations, required under Division 2;

    • (c) distribute as a distributor referred to in section C.01A.003 a drug other than

      • (i) an active pharmaceutical ingredient, or

      • (ii) an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act; or

    • (d) wholesale a drug other than

      • (i) an active pharmaceutical ingredient, or

      • (ii) an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act.

  • (2) A person does not require an establishment licence to perform tests under Division 2 if the person holds an establishment licence as a fabricator, a packager/labeller, a distributor referred to in paragraph C.01A.003(b) or an importer.

  • (3) No person shall carry on an activity referred to in subsection (1) unless the person holds

    • (a) in respect of a narcotic as defined in the Narcotic Control Regulations, a licence for that narcotic under those Regulations;

    • (b) in respect of a controlled drug as defined in section G.01.001, a licence for that drug under Part G; or

    • (c) in respect of a drug containing cannabis as defined in subsection 2(1) of the Cannabis Act, a licence for that drug to conduct that activity under the Cannabis Regulations.

  • SOR/97-12, s. 5
  • SOR/2002-368, s. 3
  • SOR/2013-74, s. 4
  • SOR/2017-259, s. 13
  • SOR/2018-144, s. 368
  • SOR/2019-171, s. 24
  • SOR/2022-100, s. 3

Date modified: