Controlled Substances Regulations (SOR/2025-242)

Marginal note:Authorized persons

• The following provision is not in force.

  5 (1) A person referred to in subsection (2) is authorized to possess any of the following controlled substances if the person has obtained the substance in accordance with these Regulations, in the course of acts conducted in connection with the administration or enforcement of an Act or regulation or from a person exempted under subsection 56(1) of the Act from the application of subsection 5(1) of the Act with respect to that controlled substance:

  • The following provision is not in force.

    (a) a narcotic set out in Schedule 1;

  • The following provision is not in force.

    (b) a controlled drug set out in Part 1 of Schedule 2;

  • The following provision is not in force.

    (c) a targeted substance set out in Part 1 of Schedule 3.

• The following provision is not in force.

  Marginal note:Conditions

  (2) An authorized person is

  • The following provision is not in force.

    (a) a person that conducts an activity, with respect to the controlled substance, that is necessary for their business or the practice of their profession and that is

    • (i) a licensed dealer,

    • (ii) a pharmacist or pharmacy technician, other than one who is practising in a hospital, or

    • (iii) a practitioner who is registered and entitled to practise in

      • (A) the province in which they possess the controlled substance, or

      • (B) a province other than the province in which they possess the controlled substance, if they possess the substance for emergency medical purposes only;

  • The following provision is not in force.

    (b) a hospital;

  • The following provision is not in force.

    (c) the Minister;

  • The following provision is not in force.

    (d) an inspector, member of the Royal Canadian Mounted Police, peace officer or member of the technical or scientific staff of the federal government, a provincial government or a university in Canada who possesses the controlled substance in connection with their employment;

  • The following provision is not in force.

    (e) a particular person that possesses the substance for the purposes of destruction; or

  • The following provision is not in force.

    (f) an individual who

    • (i) has obtained the controlled substance for their own use, for the use of another individual or for an animal in accordance with a prescription that was issued or obtained in accordance with these Regulations from one of the following persons:

      • (A) a practitioner, or

      • (B) a pharmacist, or

    • (ii) has imported the controlled substance

      • (A) for their own use,

      • (B) for the use and on the behalf of an accompanying individual, or

      • (C) for an animal for which the individual is responsible and that is accompanying the individual.

• The following provision is not in force.

  Marginal note:Agent or mandatary — person in paragraph (2)(d)

  (3) An agent or mandatary of a person referred to in paragraph (2)(d) may only have a controlled substance set out in subsection (1) in their possession if

  • The following provision is not in force.

    (a) they have reasonable grounds to believe that person is a person referred to in paragraph (2)(d); and

  • The following provision is not in force.

    (b) they possess the controlled substance for the purpose of assisting that person in the administration or enforcement of an Act or regulation.

• The following provision is not in force.

  Marginal note:Export

  (4) A licensed dealer, the Minister, a government laboratory or an individual referred to in section 226 may possess a controlled substance, other than a restricted drug, for the purpose of exporting it if the substance was obtained in accordance with these Regulations.

Marginal note:Authorized persons

• The following provision is not in force.

  6 (1) The following persons are authorized to possess any restricted drug listed in Part 1 of Schedule 4 if that person has obtained the drug in accordance with these Regulations or in the course of acts conducted in connection with the administration or enforcement of an Act or regulation:

  • The following provision is not in force.

    (a) a licensed dealer;

  • The following provision is not in force.

    (b) a pharmacist or pharmacy technician, other than one who is practising in a hospital;

  • The following provision is not in force.

    (c) a practitioner who is named in a letter of authorization;

  • The following provision is not in force.

    (d) the Minister;

  • The following provision is not in force.

    (e) an inspector, member of the Royal Canadian Mounted Police, peace officer or member of the technical or scientific staff of the federal government, a provincial government or a university in Canada who possesses the restricted drug in connection with their employment;

  • The following provision is not in force.

    (f) a particular person that possesses the substance for the purposes of destruction; and

  • The following provision is not in force.

    (g) an individual who has obtained the restricted drug for their own use from a practitioner named in a letter of authorization.

• The following provision is not in force.

  Marginal note:Agent or mandatary — person in paragraph (1)(e)

  (2) An agent or mandatary of a person referred to in paragraph (1)(e) may only have a restricted drug listed in Part 1 of Schedule 4 in their possession if

  • The following provision is not in force.

    (a) they have reasonable grounds to believe that person is a person referred to in paragraph (1)(e); and

  • The following provision is not in force.

    (b) they possess the restricted drug for the purpose of assisting that person in the administration or enforcement of an Act or regulation.

• The following provision is not in force.

  Marginal note:Export

  (3) A licensed dealer, the Minister or a government laboratory may possess a restricted drug for the purpose of exporting it if the drug was obtained in accordance with these Regulations.

Marginal note:Activities

• The following provision is not in force.

  7 (1) Persons referred to in subsection (2) are required to obtain a dealer’s licence for each site at which that person intends to conduct one of the following activities:

  • The following provision is not in force.

    (a) producing a controlled substance, unless the person doing so is

    • (i) a pharmacist or pharmacy technician who is compounding a finished product in accordance with these Regulations, or

    • (ii) a government laboratory;

  • The following provision is not in force.

    (b) packaging, selling, providing, delivering, sending or transporting a controlled substance, unless the person doing so is:

    • (i) a pharmacist or pharmacy technician who is not practising in a hospital,

    • (ii) a practitioner,

    • (iii) a hospital,

    • (iv) the Minister,

    • (v) a government laboratory,

    • (vi) a particular person, or

    • (vii) an individual referred to in section 223 or 224;

  • The following provision is not in force.

    (c) importing or exporting a controlled substance, unless the person doing so is

    • (i) the Minister,

    • (ii) a government laboratory, or

    • (iii) an individual referred to in section 225 or 226; and

  • The following provision is not in force.

    (d) destroying a controlled substance, if that is the only activity that the person intends to conduct.

• The following provision is not in force.

  Marginal note:Eligible persons

  (2) The persons that are eligible to obtain a dealer’s licence are

  • The following provision is not in force.

    (a) an individual who ordinarily resides in Canada;

  • The following provision is not in force.

    (b) an organization that has its head office in Canada or operates a branch office in Canada; or

  • The following provision is not in force.

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

Marginal note:Senior person in charge

• The following provision is not in force.

  8 (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 senior person in charge who has overall responsibility for management of the activities with respect to controlled substances that are specified in the licence application.

• The following provision is not in force.

  Marginal note:Qualifications

  (2) Only an individual who has sufficient knowledge of the provisions of the Act and these Regulations that are applicable to the activities specified in the licence application to properly carry out their duties may be designated as a senior person in charge.

Marginal note:Qualified person in charge

• The following provision is not in force.

  9 (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;

  • The following provision is not in force.

    (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

  • The following provision is not in force.

    (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;

  • The following provision is not in force.

    (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.

Marginal note:Ineligibility

• The following provision is not in force.

  10 (1) 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,

  • The following provision is not in force.

    (a) in respect of a designated substance offence, a cannabis offence or any other offence referred to in subsection (2), 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

  • The following provision is not in force.

    (b) in respect of an offence committed outside Canada that, if committed in Canada, would have constituted a designated substance offence, a cannabis offence or any other offence referred to in subsection (2),

    • (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 individual 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.

• The following provision is not in force.

  Marginal note:Other offences

  (2) For the purposes of subsection (1), the other offences are

  • The following provision is not in force.

    (a) an offence involving the financing of terrorism referred to in any of sections 83.02 to 83.04 of the Criminal Code;

  • The following provision is not in force.

    (b) an offence involving fraud referred to in any of sections 380 to 382 of the Criminal Code;

  • The following provision is not in force.

    (c) the offence of laundering proceeds of crime referred to in section 462.31 of the Criminal Code;

  • The following provision is not in force.

    (d) an offence involving a criminal organization referred to in any of sections 467.11 to 467.13 of the Criminal Code; and

  • The following provision is not in force.

    (e) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in any of paragraphs (a) to (d).