Food and Drug Regulations
C.01A.004 (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) 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
- Date modified: