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 a drug as set out in section C.01A.003 that is not an active pharmaceutical ingredient; or

• (d) wholesale a drug that is not an active pharmaceutical ingredient.

(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.