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 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.