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

Marginal note:Refusal

• J.01.042 (1) The Minister must refuse to issue an import permit if

  • (a) the licensed dealer is not authorized by their dealer’s licence to import the relevant restricted drug or their licence will expire before the date of importation;

  • (b) the Minister has reasonable grounds to believe that the importation would contravene an international obligation;

  • (c) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of the importation;

  • (d) the licensed dealer has not complied with the requirements of subsection J.01.038(3) or the information or documents that they have provided are not sufficient to complete the review of the permit application;

  • (e) 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 permit application;

  • (f) the licensed dealer has been notified that their application to renew or amend their licence will be refused;

  • (g) the Minister has reasonable grounds to believe that the importation would contravene the laws of the country of export or any country of transit or transhipment; or

  • (h) the Minister has reasonable grounds to believe that the issuance of the permit 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:Notice

  (2) Before refusing to issue the import permit, 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:Providing copy of permit

J.01.043 The holder of an import permit must provide a copy of the permit to the customs office at the time of importation.

Marginal note:Declaration

J.01.044 The holder of an import permit must provide the Minister, within 15 days after the day of release of the restricted drug specified in the permit in accordance with the Customs Act, with a declaration that contains the following information:

• (a) their name and the numbers of their dealer’s licence and the import permit that applies to the restricted drug;

• (b) with respect to the restricted drug,

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

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

  • (iii) its quantity;

• (c) if the restricted drug is contained in a product that they have 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; and

• (d) the name of the customs office from which the restricted drug was released and the date of the release.

Marginal note:Suspension

• J.01.045 (1) The Minister must suspend an import permit without prior notice if

  • (a) the dealer’s licence is suspended;

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

  • (c) the importation would contravene the laws of the country of export or any country of transit or transhipment.

• 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 permit

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

Marginal note:Revocation

• J.01.046 (1) Subject to subsection (2), the Minister must revoke an import permit if

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

  • (b) the licensed dealer does not carry out the corrective measures specified by the Minister under paragraph J.01.045(2)(c) by the specified date;

  • (c) the licensed dealer has contravened a term or condition of the permit;

  • (d) 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 the application for the permit;

  • (e) 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

  • (f) the dealer’s licence has been revoked.

• Marginal note:Exceptions

  (2) The Minister must not revoke an import permit for a ground set out in paragraph (1)(d) or J.01.036(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 an import permit, 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 permit

J.01.047 If an import permit is revoked, the licensed dealer must return the original of the permit to the Minister within 15 days after the effective date of the revocation.

Export Permits

Marginal note:Application

• J.01.048 (1) A licensed dealer must submit to the Minister, before each exportation of a restricted drug, an application for an export permit that contains the following information and document:

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

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

    • (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 exported,

    • (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 of the importer in the country of final destination;

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

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

  • (g) a copy of the import permit issued by the competent authority in the country of final destination that sets out the name of the importer and the municipal address of their site in that country.

• 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, to the best of their knowledge,

    • (i) the exportation does not contravene the laws of the country of final destination or any country of transit or transhipment, and

    • (ii) all of the information and documents submitted in support of the application are correct and complete.

• 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.01.049 Subject to section J.01.052, on completion of the review of the export permit application, the Minister must issue to the licensed dealer an export permit that contains

• (a) the permit number;

• (b) the information set out in paragraphs J.01.048(1)(a) to (f);

• (c) the effective date of the permit;

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

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

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

  • (iii) the expiry date of the import permit issued by the competent authority in the country of final destination; 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.01.050 An export 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.01.055 or J.01.056,

• (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 expiry, suspension or revocation of the import permit that applies to the restricted drug to be exported and that is issued by the competent authority in the country of final destination.