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

J.01.032.1 [Repealed, SOR/2019-171, s. 22]

Changes to Terms and Conditions of Licence

Marginal note:Addition of or modification to term or condition

• J.01.033 (1) The Minister may, at any time other than at the issuance, renewal or amendment of a dealer’s licence, add a term or condition to it or modify one if the Minister has reasonable grounds to believe that it is necessary to do so 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

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

• Marginal note:Notice

  (2) Before adding a term or condition to a licence or modifying one, 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.

• Marginal note:Urgent circumstances

  (3) Despite subsection (2), the Minister may add a term or condition to a licence or modify one without prior notice if 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.

• Marginal note:Urgent circumstances — notice

  (4) The addition or modification of a term or condition that is made under subsection (3) takes effect as soon as the Minister sends the licensed dealer a notice that

  • (a) sets out the reasons for the addition or modification;

  • (b) gives the dealer an opportunity to be heard; and

  • (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

J.01.033.1 [Repealed, SOR/2019-171, s. 22]

J.01.033.2 [Repealed, SOR/2019-171, s. 22]

J.01.033.3 [Repealed, SOR/2019-171, s. 22]

J.01.033.4 [Repealed, SOR/2019-171, s. 22]

Marginal note:Deletion of term or condition

• J.01.034 (1) The Minister may delete a term or condition of a dealer’s licence that the Minister determines is no longer necessary.

• Marginal note:Notice

  (2) The deletion takes effect as soon as the Minister sends the licensed dealer a notice to that effect.

Suspension and Revocation of Licence

Marginal note:Suspension

• J.01.035 (1) The Minister must suspend a dealer’s licence without prior notice if 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.

• Marginal note:Notice

  (2) The suspension takes effect as soon as the Minister sends the licensed dealer a notice that

  • (a) sets out the reasons for the suspension;

  • (b) gives the dealer an opportunity to be heard; and

  • (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

• Marginal note:Reinstatement of licence

  (3) The Minister must reinstate the licence if the Minister has reasonable grounds to believe that the suspension is no longer necessary.

Marginal note:Revocation

• J.01.036 (1) Subject to subsection (2), the Minister must revoke a dealer’s licence if

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

  • (b) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the licence or the actual or potential unauthorized use of the licence;

  • (c) the licensed dealer ceases to conduct activities at their site before the expiry of their licence;

  • (d) the licensed dealer does not take the corrective measures specified in an undertaking or notice;

  • (e) 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;

  • (f) during the 10 years before the day on which the licence is revoked, the senior person in charge, the qualified person in charge or any 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);

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

  • (h) 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.

• Marginal note:Exceptions

  (2) The Minister must not revoke a dealer’s licence for a ground set out in paragraph (1)(e) or (g) 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 revoking 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.

Marginal note:Return of licence

J.01.037 The licensed dealer must return the original of the licence to the Minister within 15 days after the effective date of the revocation.

Import Permits

Marginal note:Application

• J.01.038 (1) A licensed dealer must submit to the Minister, before each importation of a restricted drug, an application for an import permit that contains the following information:

  • (a) their name, municipal address and dealer’s licence number;

  • (b) with respect to the restricted drug to be imported,

    • (i) its name, as specified in the dealer’s licence,

    • (ii) if it is a salt, the name of the salt,

    • (iii) its quantity, and

    • (iv) in the case of a raw material, its purity and its anhydrous content;

  • (c) if the restricted drug is contained in a product to be imported,

    • (i) the brand name of the product,

    • (ii) the drug identification number that has been assigned to the product under section C.01.014.2, if any, and

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

  • (d) the name and municipal address, in the country of export, of the exporter from whom the restricted drug is being obtained;

  • (e) the name of the customs office where the importation is anticipated; and

  • (f) each proposed mode of transportation and any proposed country of transit or transhipment.

• Marginal note:Signature and attestation

  (2) The application must

  • (a) be signed and dated by the qualified person in charge or an alternate qualified person in charge; and

  • (b) include an attestation by that person that all of the information submitted in support of the application is correct and complete to the best of their knowledge.

• 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.

Marginal note:Issuance

J.01.039 Subject to section J.01.042, on completion of the review of the import permit application, the Minister must issue to the licensed dealer an import permit that contains

• (a) the permit number;

• (b) the information set out in subsection J.01.038(1);

• (c) the effective date of the permit;

• (d) the expiry date of the permit, being the earlier of

  • (i) a date specified by the Minister that is not more than 180 days after its effective date, and

  • (ii) the expiry date of the dealer’s licence; and

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

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

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

Marginal note:Validity

J.01.040 An import permit is valid until the earliest of

• (a) the expiry date set out in the permit,

• (b) the date of the suspension or revocation of the permit under section J.01.045 or J.01.046,

• (c) the date of the suspension or revocation of the dealer’s licence under section J.01.035 or J.01.036, and

• (d) the date of the suspension or revocation of the export permit that applies to the restricted drug to be imported and that is issued by the competent authority in the country of export.

Marginal note:Return of permit

J.01.041 If an import permit expires, the licensed dealer must return the original of the permit to the Minister within 15 days after its expiry.