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 2020-07-28 and last amended on 2015-06-13. Previous Versions

 [Repealed, SOR/2019-171, s. 22]

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 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.

  • SOR/2004-238, s. 34
  • SOR/2019-171, s. 22

Marginal note:Application

  •  (1) A person who intends to conduct an activity referred to in section J.01.009 must obtain a dealer’s licence for each site at which they intend to conduct activities by submitting an application to the Minister that contains the following information:

    • (a) if the licence is requested by

      • (i) an individual, the individual’s name,

      • (ii) a corporation, its corporate name and any other name registered with a province under which it intends to conduct the activities specified in its dealer’s licence or by which it intends to identify itself, and

      • (iii) the holder of a position mentioned in paragraph J.01.010(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 proposed site 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 restricted drugs in respect of which each of the activities is to be conducted;

    • (f) if the licence is requested to manufacture or assemble a product or compound that contains a restricted drug, other than a test kit, a list that includes, for each product or compound,

      • (i) the brand name of the product or the name of the compound,

      • (ii) the name of the restricted drug in the product or compound,

      • (iii) the strength per unit of the restricted drug in it, the number of units per package and the number of packages,

      • (iv) if it is to be manufactured or assembled by or for another licensed dealer under a custom order, the name, municipal address and dealer’s licence number of the other licensed dealer, and

      • (v) if the applicant’s name appears on the label of the product or compound, a copy of the inner label;

    • (g) if the licence is requested in order to produce a restricted drug other than a product or compound that contains a restricted drug,

      • (i) the name of the restricted drug,

      • (ii) the quantity that the applicant expects to produce under their licence and the period during which that quantity would be produced, and

      • (iii) if it is to be produced for another licensed dealer under a custom order, the name, municipal address and licence number of the other licensed dealer;

    • (h) if the licence is requested for an activity that is not described in paragraph (f) or (g), the name of the restricted drug 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 for recording information that the applicant proposes to use for the purpose of section J.01.075.

  • Marginal note:Documents

    (2) An application for a dealer’s licence must be accompanied by the following documents:

    • (a) if the applicant is a corporation, a copy of

      • (i) the certificate of incorporation or other constituting instrument, and

      • (ii) any document filed with the province in which its site is located that states its corporate name and any other name registered with the province under which the applicant intends to conduct the activities specified in its dealer’s licence or by which it intends to identify itself;

    • (b) individual declarations signed and dated by each of the proposed senior person in charge, and qualified person in charge and any proposed alternate qualified person in charge, attesting that the person is not ineligible for a reason specified in section J.01.013;

    • (c) a document issued by a Canadian police force 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 J.01.013(a)(i) or received a sentence as specified in subparagraph J.01.013(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 J.01.013(b)(i) or received a sentence as specified in subparagraph J.01.013(b)(ii);

    • (e) declaration, signed and dated by the proposed senior person in charge, attesting that the proposed qualified person in charge and any proposed alternate qualified person in charge have the knowledge and experience required under paragraphs J.01.012(3)(c) and (d); and

    • (f) if the proposed qualified person in charge or any proposed alternate qualified person in charge does not meet the requirement of subparagraph J.01.012(3)(b)(i), either

      • (i) a copy of the person’s diploma, certificate or credential referred to in subparagraph J.01.012(3)(b)(ii) or (iii), or

      • (ii) a detailed description of the education, training and work experience that is required under paragraph J.01.012(4)(c), together with supporting evidence, 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 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.

  • SOR/2019-171, s. 22

Sale of a Restricted Drug

Marginal note:Issuance

 Subject to section J.01.017, on completion of the review of the licence application, the Minister must issue a dealer’s licence, with or without terms and conditions, that contains

  • (a) the licence number;

  • (b) the name of the licensed dealer, their corporate name or the title of the position they hold;

  • (c) the activities that are authorized and the names of the restricted drugs in respect of which each activity may be conducted;

  • (d) the municipal address of the site at which the dealer may conduct the authorized activities;

  • (e) the security level at the site, determined in accordance with the Security Directive;

  • (f) the effective date of the licence;

  • (g) the expiry date of the licence, which must be not later than three years after its effective date;

  • (h) any terms and conditions that the Minister has reasonable grounds to believe are necessary to

    • (i) ensure that an international obligation is respected,

    • (ii) ensure conformity with the requirements associated with the security level that is referred to in paragraph (e), or

    • (iii) reduce a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use; and

  • (i) if the licensed dealer produces a restricted drug, the quantity that they may produce and the authorized production period.

  • SOR/2019-171, s. 22

Marginal note:Validity

 A dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section J.01.035 or J.01.036.

  • SOR/2019-171, s. 22

Marginal note:Refusal

  •  (1) The Minister must refuse to issue a dealer’s licence if

    • (a) the applicant may not apply for a licence under section J.01.010;

    • (b) during the 10 years before the day on which the licence application is submitted, the applicant has contravened

      • (i) a provision of the Act, the Cannabis Act or their regulations, or

      • (ii) a term or condition of a licence or permit issued to the applicant under any regulations made under the Act or issued to the applicant under the Cannabis Act or its regulations;

    • (c) during the 10 years before the day on which the licence application is submitted the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph J.01.013(a)(i) or (b)(i) or received a sentence as specified in subparagraph J.01.013(a)(ii) or (b)(ii);

    • (d) an activity for which the licence is requested would contravene an international obligation;

    • (e) the applicant does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the licence is requested;

    • (f) the method referred to in paragraph J.01.014(1)(j) does not permit the recording of information as required under section J.01.075;

    • (g) the applicant has not complied with the requirements of subsection J.01.014(4) or the information and documents that they have provided are not sufficient to complete the review of the licence application;

    • (h) the Minister has reasonable grounds to believe that the applicant has submitted false or misleading information or false or falsified documents in or in support of the licence application;

    • (i) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the applicant has been involved in the diversion of a restricted drug to an illicit market or use or has been involved in an activity that contravened an international obligation; or

    • (j) the Minister has reasonable grounds to believe that the issuance of the licence would likely create a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

  • Marginal note:Exceptions

    (2) The Minister must not refuse to issue a licence under paragraph (1)(b) or (h) if the applicant meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a restricted drug from being diverted to an illicit market or use:

    • (a) the applicant does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and

    • (b) the applicant has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

  • Marginal note:Notice

    (3) Before refusing to issue a licence, the Minister must send the applicant a notice that sets out the Minister’s reasons and gives the applicant an opportunity to be heard.

  • SOR/2019-171, s. 22

Marginal note:Application

  •  (1) To apply to renew a dealer’s licence, a licensed dealer must submit to the Minister an application that contains the information and documents referred to in subsections J.01.014(1) and (2).

  • Marginal note:Signature and attestation

    (2) The application must

    • (a) be signed and dated by the senior person in charge of the site specified in the application; 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 licensed dealer.

  • Marginal note:Additional information and documents

    (3) The licensed dealer 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.

  • SOR/2019-171, s. 22

Marginal note:Renewal

  •  (1) Subject to section J.01.021, on completion of the review of the renewal application, the Minister must issue a renewed dealer’s licence that contains the information specified in section J.01.015.

  • Marginal note:Terms and conditions

    (2) When renewing a dealer’s licence, the Minister may, if he or she has reasonable grounds to believe that it is necessary to do so, add a term or condition to it or modify or delete one in order to

    • (a) ensure that an international obligation is respected;

    • (b) ensure conformity with the requirements associated with the security level specified in the licence or the new level required as a result of the licence renewal; or

    • (c) reduce a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

  • SOR/2019-171, s. 22

Marginal note:Validity

 A renewed dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section J.01.035 or J.01.036.

  • SOR/2019-171, s. 22

Records and Inspection

Marginal note:Refusal

  •  (1) The Minister must refuse to renew a dealer’s licence if

    • (a) the licensed dealer may no longer apply for a licence under section J.01.010;

    • (b) during the 10 years before the day on which the renewal application is submitted, the licensed dealer has contravened

      • (i) a provision of the Act, the Cannabis Act or their Regulations, or

      • (ii) a term or condition of a licence or permit issued to the dealer under a regulation made under the Act or issued to the dealer under the Cannabis Act or its regulations;

    • (c) during the 10 years before the day on which the renewal application is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph J.01.013(a)(i) or (b)(i) or received a sentence as specified in subparagraph J.01.013(a)(ii) or (b)(ii);

    • (d) an activity for which the renewal is requested would contravene an international obligation;

    • (e) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the renewal is requested;

    • (f) the method referred to in paragraph J.01.014(1)(j) does not permit the recording of information as required under section J.01.075;

    • (g) the licensed dealer has not complied with the requirements of subsection J.01.018(3) or the information or documents that they have provided are not sufficient to complete the review of the renewal application;

    • (h) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the renewal application;

    • (i) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a restricted drug to an illicit market or use or has been involved in an activity that contravened an international obligation; or

    • (j) the Minister has reasonable grounds to believe that the renewal of the licence would likely create a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

  • Marginal note:Exceptions

    (2) The Minister must not refuse to renew a licence under paragraph (1)(b) or (h) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a restricted drug from being diverted to an illicit market or use:

    • (a) the licensed dealer does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and

    • (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

  • Marginal note:Notice

    (3) Before refusing to renew a licence, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

  • SOR/85-550, s. 15
  • SOR/2019-171, s. 22

Marginal note:Application

  •  (1) Before making a change affecting any information referred to in section J.01.015 that is contained in their dealer’s licence, a licensed dealer must submit to the Minister an application to amend the licence that contains a description of the proposed amendment, as well as the information and documents referred to in section J.01.014 that are relevant to the proposed amendment.

  • Marginal note:Signature and attestation

    (2) The application must

    • (a) be signed and dated by the senior person in charge of the site specified in the application; 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 licensed dealer.

  • Marginal note:Additional information and documents

    (3) The licensed dealer 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.

  • SOR/2019-171, s. 22

Marginal note:Amendment

  •  (1) Subject to section J.01.025, on completion of the review of the amendment application, the Minister must amend the dealer’s licence.

  • Marginal note:Terms and conditions

    (2) When amending a dealer’s licence, the Minister may, if he or she has reasonable grounds to believe that it is necessary to do so, add a term or condition to it or modify or delete one in order to

    • (a) ensure that an international obligation is respected;

    • (b) ensure conformity with the requirements associated with the security level specified in the licence or the new level required as a result of the amendment; or

    • (c) reduce a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

  • SOR/2004-238, s. 35
  • SOR/2010-222, s. 31(F)
  • SOR/2019-171, s. 22
 
Date modified: