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Controlled Substances Regulations (SOR/2025-242)

Regulations are current to 2026-09-30

The following provision is not in force.

Marginal note:Qualified person in charge

  • The following provision is not in force.

     (1) An applicant for a dealer’s licence must designate only one individual, who may be the applicant if the applicant is an individual, as the qualified person in charge who is responsible for supervising the activities with respect to controlled substances that are specified in the licence application and for ensuring that those activities comply with these Regulations, as well as with any terms or conditions of the licence and any permit issued under these Regulations.

  • The following provision is not in force.

    Marginal note:Alternate qualified person in charge

    (2) An applicant for a dealer’s licence may designate an individual, who may be the applicant if the applicant is 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 following provision is not in force.

    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:

    • The following provision is not in force.

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

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      (b) they

      • (i) 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

      • (ii) hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (i) and hold one of the following assessments that establishes the equivalency of the diploma, certificate or credential to one of the documents referred to in that subparagraph:

        • (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 institution or organization that is responsible for issuing equivalency assessments and is recognized by a province;

    • The following provision is not in force.

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

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

  • The following provision is not in force.

    Marginal note:Exception

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

    • The following provision is not in force.

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

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

    • The following provision is not in force.

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

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