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

Marginal note:Cancellation of registration number

J.01.008 The Minister must cancel the registration number for a test kit if

• (a) the test kit is removed from the market by the manufacturer;

• (b) the Minister has reasonable grounds to believe that the test kit is used or is likely to be used for any purpose other than a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; or

• (c) the Minister has reasonable grounds to believe that the cancellation is necessary to protect public health or safety, including to prevent a restricted drug from being diverted to an illicit market or use.

Licensed Dealers

Authorized Activities

Marginal note:General

• J.01.009 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a restricted 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 restricted 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 restricted drug.

• Marginal note:Possession for export

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

Dealer’s Licences

Preliminary Requirements

Marginal note:Eligible persons

J.01.010 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 restricted drugs on behalf of the Government of Canada or of a government of a province, a police force, a hospital or a university in Canada.

Marginal note:Senior person in charge

J.01.011 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 restricted drugs that are specified in the licence application. The applicant may designate themself if the applicant is an individual.

Marginal note:Qualified person in charge

• J.01.012 (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 restricted 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 restricted 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.

J.01.012.1 [Repealed, SOR/2019-171, s. 22]

J.01.012.2 [Repealed, SOR/2019-171, s. 22]

Marginal note:Ineligibility

J.01.013 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.

Issuance of Licence

Marginal note:Application

• J.01.014 (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.

Marginal note:Issuance

J.01.015 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.