Food and Drug Regulations

Version of section C.01A.004 from 2018-06-13 to 2018-10-16:

  •  (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 that is not an active pharmaceutical ingredient or 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 that is not an active pharmaceutical ingredient or 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) in respect of a narcotic as defined in the Narcotic Control Regulations or a controlled drug as defined in subsection G.01.001(1) unless the person holds a licence for that narcotic or drug under the Narcotic Control Regulations or Part G of these Regulations, as the case may be.

  • SOR/97-12, s. 5;
  • SOR/2002-368, s. 3;
  • SOR/2013-74, s. 4;
  • SOR/2017-259, s. 13.
Date modified: