Food and Drug Regulations (C.R.C., c. 870)

Regulations are current to 2013-06-10 and last amended on 2013-05-31. Previous Versions

Division 2

Licences And Licensed Dealers

 Subject to this Part, no person except a licensed dealer shall produce, make, assemble, import, export, sell, provide, transport, send or deliver a controlled drug.

  • SOR/2004-238, s. 3.

 To be eligible for a dealer’s licence, a person must be

  • (a) an individual who ordinarily resides in Canada;

  • (b) a corporation that has its head office in Canada or operates a branch office in Canada; or

  • (c) the holder of a position that includes responsibility for controlled drugs on behalf of a department of the Government of Canada or of a government of a province, a police force, a hospital or a university in Canada.

  • SOR/2004-238, s. 3.
  •  (1) A licensed dealer

    • (a) shall designate one qualified person in charge, who may be the licensed dealer if the licensed dealer is an individual, who must work at the premises specified in the licence, have responsibility for supervising activities with respect to controlled drugs specified in the licence and for ensuring, on behalf of the licensed dealer, that those activities comply with these Regulations; and

    • (b) may designate an alternate qualified person in charge who must work at the premises specified the licence and have authority to replace the qualified person in charge when that person is absent.

  • (2) The qualified person in charge and, if applicable, the alternate qualified person in charge

    • (a) shall be familiar with the provisions of the Act and the regulations under it that apply to the licence of the licensed dealer who designated them and have knowledge of chemistry and pharmacology and experience in those fields to properly carry out their duties;

    • (b) shall either

      • (i) be a pharmacist or a practitioner of medicine, dentistry or veterinary medicine, registered with a provincial professional licensing authority, or

      • (ii) possess a degree in an applicable science — such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, organic chemistry or chemical engineering — that is awarded by a Canadian university or, if awarded by a foreign university, that is recognized by a Canadian university or a Canadian professional association; and

    • (c) shall not have been convicted, as an adult, within the preceding 10 years, of

      • (i) a designated drug offence,

      • (ii) a designated criminal offence, or

      • (iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii).

  • SOR/2004-238, s. 3;
  • SOR/2010-222, ss. 1(E), 34;
  • SOR/2012-230, s. 7.

 No licensed dealer may import or export a controlled drug without a permit.