Controlled Substances Regulations (SOR/2025-242)
Full Document:
- HTMLFull Document: Controlled Substances Regulations (Accessibility Buttons available) |
- XMLFull Document: Controlled Substances Regulations [670 KB] |
- PDFFull Document: Controlled Substances Regulations [1157 KB]
Regulations are current to 2026-10-19 and last amended on 2026-10-01. Previous Versions
Possession (continued)
Restricted Drugs
Marginal note:Authorized persons
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:
(a) a licensed dealer;
(b) a pharmacist or pharmacy technician, other than one who is practising in a hospital;
(c) a practitioner who is named in a letter of authorization;
(d) the Minister;
(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;
(f) a particular person that possesses the substance for the purposes of destruction; and
(g) an individual who has obtained the restricted drug for their own use from a practitioner named in a letter of authorization.
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
(a) they have reasonable grounds to believe that person is a person referred to in paragraph (1)(e); and
(b) they possess the restricted drug for the purpose of assisting that person in the administration or enforcement of an Act or regulation.
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.
Licensed Dealers
Dealer’s Licence
Requirement to Obtain
Marginal note:Activities
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:
(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;
(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;
(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
(d) destroying a controlled substance, if that is the only activity that the person intends to conduct.
Marginal note:Eligible persons
(2) The persons that are eligible to obtain a dealer’s licence are
(a) an individual who ordinarily resides in Canada;
(b) an organization 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 substances on behalf of the government of Canada or of a province, a police force, a hospital or a university in Canada.
Preliminary Requirements
Marginal note:Senior person in charge
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.
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
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.
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.
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 application;
(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;
(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
(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.
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
(a) no other individual working at the site meets those requirements;
(b) those requirements are not necessary for the activities specified in the licence application; and
(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
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,
(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
(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.
Marginal note:Other offences
(2) For the purposes of subsection (1), the other offences are
(a) an offence involving the financing of terrorism referred to in any of sections 83.02 to 83.04 of the Criminal Code;
(b) an offence involving fraud referred to in any of sections 380 to 382 of the Criminal Code;
(c) the offence of laundering proceeds of crime referred to in section 462.31 of the Criminal Code;
(d) an offence involving a criminal organization referred to in any of sections 467.11 to 467.13 of the Criminal Code; and
(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).
Issuance of a Licence
Marginal note:Application
11 (1) An application to obtain a dealer’s licence must be submitted to the Minister and must contain
(a) if the licence is requested by
(i) an individual, the individual’s name,
(ii) an organization, the name by which it intends to identify itself or under which it intends to conduct the activities specified in the licence application and, if applicable, its corporate name and any other name registered with a province, and
(iii) the holder of a position described in paragraph 7(2)(c), the applicant’s name and the title of the position;
(b) the municipal address, telephone number and, if applicable, the email address of the site specified in the licence application and, if different from the municipal address, its mailing address;
(c) the name, date of birth, telephone number and email address of the proposed senior person in charge;
(d) with respect to each of the proposed qualified person in charge and any proposed alternate qualified person in charge,
(i) their name, date of birth, telephone number and email address,
(ii) the title of their position at the site,
(iii) the name and title of the position of their immediate supervisor at the site,
(iv) if applicable, the profession they practise that is relevant to their duties, the name of the province that authorizes them to practise it and their authorization number, and
(v) their education, training and work experience that are relevant to their duties;
(e) the activities that are to be conducted and the controlled substance in respect of which each of the activities is to be conducted;
(f) if the licence is requested in order to produce or package a controlled substance set out in any of Schedules 1 to 4, for each substance,
(i) its name, its CAS registry number, if any, as well as its form, the quantity that the applicant intends to produce under the licence and the period during which that quantity would be produced, and
(ii) if it is to be produced or packaged for another licensed dealer under a custom order, the name, and if applicable, title, as well as the municipal address and licence number of the other licensed dealer;
(g) if the licence is requested to produce or package a mixture or finished product, for each mixture or finished product,
(i) its name or, if applicable, brand name, as well as the name of the controlled substance it contains,
(ii) its form, its strength, the number of containers and, if applicable, the number of units per container,
(iii) its drug identification number, if any,
(iv) if it is to be produced or packaged by or for another licensed dealer under a custom order, the name, and if applicable, title, as well as the municipal address and licence number of the other licensed dealer, and
(v) if the applicant’s name appears on any label, as defined in section 2 of the Food and Drugs Act, of the finished product, a copy of that label;
(h) if the licence is requested for an activity that is not described in paragraph (f) or (g), the name of the controlled substance for which the activity is to be conducted and the purpose of the activity;
(i) a detailed description of the security measures in place at the site, determined in accordance with the Security Directive; and
(j) a detailed description of the method of recording information that the applicant proposes to use for the purposes of section 86.
Marginal note:Documents
(2) The application must be accompanied by the following documents:
(a) if the applicant is an organization, a copy of
(i) the certificate of incorporation or other constituting instrument,
(ii) any document filed with the province in which its site is located that states the name by which it intends to identify itself or under which it intends to conduct the activities specified in the licence application and, if applicable, its corporate name and any other name registered with a province, and
(iii) the permit or licence that is issued by the municipality in which its site is located that authorizes the business to operate, if applicable;
(b) individual declarations, signed and dated by each of the proposed senior person in charge, the qualified person in charge and any proposed alternate qualified person in charge, attesting that the signatory is not ineligible for a reason specified in section 10;
(c) a document issued by a Canadian police force or by a business that is accredited by the Royal Canadian Mounted Police in relation to each person referred to in paragraph (b) indicating whether, during the 10 years before the day on which the application is submitted, the person was convicted as specified in subparagraph 10(1)(a)(i) or received a sentence as specified in subparagraph 10(1)(a)(ii);
(d) if any of the persons referred to in paragraph (b) has ordinarily resided in a country other than Canada during the 10 years before the day on which the application is submitted, a document issued by a police force of that country indicating whether in that period that person was convicted as specified in subparagraph 10(1)(b)(i) or received a sentence as specified in subparagraph 10(1)(b)(ii);
(e) a declaration, signed and dated by the proposed senior person in charge, attesting that they have the knowledge required under subsection 8(2) and that the proposed qualified person in charge and any proposed alternate qualified person in charge have the knowledge and experience required under paragraphs 9(3)(c) and (d);
(f) with respect to the proposed qualified person in charge or any proposed alternate qualified person in charge, a copy of their diploma, certificate or credential referred to in paragraph 9(3)(b) and, if applicable, the equivalency assessment referred to in subparagraph 9(3)(b)(ii); and
(g) if the proposed qualified person in charge or any proposed alternate qualified person in charge does not meet the requirement set out in paragraph 9(3)(b), a detailed description of the education, training and work experience that is required under paragraph 9(4)(c), together with supporting documents, such as a copy of a course transcript or an attestation by the person who provided the training.
Marginal note:Signature and attestation
(3) The application must
(a) be signed and dated by the proposed senior person in charge; and
(b) include an attestation by that person that
(i) all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and
(ii) they have the authority to bind the applicant.
Marginal note:Additional information and documents
(4) The applicant must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.
Page Details
- Date modified: