Government of Canada / Gouvernement du Canada
Symbol of the Government of Canada

Search

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

Regulations are current to 2020-03-05 and last amended on 2019-12-16. Previous Versions

PART GControlled Drugs (continued)

DIVISION 1General (continued)

Test Kits (continued)

 [Repealed, SOR/2019-171, s. 1]

DIVISION 2Licensed Dealers

Authorized Activities

Marginal note:General

  •  (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a controlled drug if they comply with this Part and the terms and conditions of their dealer’s licence and any permit issued under this Part.

  • Marginal note:Qualified person in charge present

    (2) A licensed dealer may conduct an activity in relation to a controlled drug at their site only if the qualified person in charge or an alternate qualified person in charge is present at the site.

  • Marginal note:Permit — import and export

    (3) A licensed dealer must obtain a permit to import or export a controlled drug.

  • Marginal note:Possession for export

    (4) A licensed dealer may possess a controlled drug for the purpose of exporting it if they have obtained it in accordance with this Part.

  • SOR/2004-238, s. 3
  • SOR/2019-171, s. 1

 [Repealed, SOR/2019-171, s. 1]

 [Repealed, SOR/2019-171, s. 1]

Dealer’s Licences

Preliminary Requirements

Marginal note:Eligible persons

 The following persons may apply for a dealer’s licence:

  • (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 the Government of Canada, the government of a province, a police force, a hospital or a university in Canada.

  • SOR/2019-171, s. 1

 [Repealed, SOR/2019-171, s. 1]

Marginal note:Senior person in charge

 An applicant for a dealer’s licence must designate only one individual as the senior person in charge, who has overall responsibility for management of the activities with respect to controlled drugs that are specified in the licence application. The applicant may designate themself if the applicant is an individual.

  • SOR/2004-238, s. 4
  • SOR/2010-222, s. 2
  • SOR/2012-230, s. 8
  • SOR/2014-260, ss. 1, 16(F)
  • SOR/2019-171, s. 1

 [Repealed, SOR/2019-171, s. 1]

 [Repealed, SOR/2019-171, s. 1]

 [Repealed, SOR/2019-171, s. 1]

 [Repealed, SOR/2019-171, s. 1]

 [Repealed, SOR/2019-171, s. 1]

 [Repealed, SOR/2019-171, s. 1]

 [Repealed, SOR/2019-171, s. 1]

 [Repealed, SOR/2019-171, s. 1]

 [Repealed, SOR/2019-171, s. 1]

 [Repealed, SOR/2019-171, s. 1]

Marginal note:Qualified person in charge

  •  (1) An applicant for a dealer’s licence must designate only one individual as the qualified person in charge, who is responsible for supervising the activities with respect to controlled drugs that are specified in the licence application and for ensuring that those activities comply with this Part. The applicant may designate themself if the applicant is an individual.

  • Marginal note:Alternate qualified person in charge

    (2) An applicant for a dealer’s licence may designate an individual as an alternate qualified person in charge, who is authorized to replace the qualified person in charge when that person is absent. The applicant may designate themself if the applicant is an individual.

  • Marginal note:Qualifications

    (3) Only an individual who meets the following requirements may be designated as a qualified person in charge or an alternate qualified person in charge:

    • (a) they work at the site specified in the dealer’s licence;

    • (b) they

      • (i) are a person entitled or, if applicable, registered and entitled by a provincial professional licensing authority or a professional association in Canada and entitled to practise a profession that is relevant to their duties, such as pharmacist, practitioner, pharmacy technician or laboratory technician,

      • (ii) hold a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to their duties, such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, chemistry, biology, pharmacy technician, laboratory technician, pharmaceutical regulatory affairs or supply chain management or security, or

      • (iii) hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (ii) and hold

        • (A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or

        • (B) an equivalency assessment issued by an organization or institution that is responsible for issuing equivalency assessments and is recognized by a province;

    • (c) they have sufficient knowledge of and experience with the use and handling of the controlled drugs specified in the dealer’s licence to properly carry out their duties; and

    • (d) they have sufficient knowledge of the provisions of the Act and this Part that are applicable to the activities specified in the dealer’s licence to properly carry out their duties.

  • Marginal note:Exception

    (4) An applicant for a dealer’s licence may designate an individual who does not meet any of the requirements of paragraph (3)(b) as a qualified person in charge or an alternate qualified person in charge if

    • (a) no other individual working at the site meets those requirements;

    • (b) those requirements are not necessary for the activities specified in the licence; and

    • (c) the individual has sufficient knowledge — acquired from a combination of education, training or work experience — to properly carry out their duties.

  • SOR/2004-238, s. 4
  • SOR/2019-171, s. 1

Marginal note:Ineligibility

 An individual is not eligible to be a senior person in charge, a qualified person in charge or an alternate qualified person in charge if, during the 10 years before the day on which the dealer’s licence application is submitted,

  • (a) in respect of a designated substance offence or a designated criminal offence or a designated offence as defined in subsection 2(1) of the Cannabis Act, the individual

    • (i) was convicted as an adult, or

    • (ii) was a young person who received an adult sentence, as those terms are defined in subsection 2(1) of the Youth Criminal Justice Act; or

  • (b) in respect of an offence committed outside Canada that, if committed in Canada, would have constituted a designated substance offence or a designated criminal offence or a designated offence as defined in subsection 2(1) of the Cannabis Act,

    • (i) the individual was convicted as an adult, or

    • (ii) if they committed the offence when they were at least 14 years old but less than 18 years old, the person received a sentence that was longer than the maximum youth sentence, as that term is defined in subsection 2(1) of the Youth Criminal Justice Act, that could have been imposed under that Act for such an offence.

  • SOR/2019-171, s. 1
 
Date modified: