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

Marginal note:Refusal

• J.01.052 (1) The Minister must refuse to issue an export permit if

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

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

  • (c) the licensed dealer has not complied with the requirements of subsection J.01.048(3) or the information or documents that they have provided are not sufficient to complete the review of the permit application;

  • (d) 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;

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

  • (f) the Minister has reasonable grounds to believe that the exportation would not be in conformity with the import permit issued by the competent authority of the country of final destination;

  • (g) the Minister has reasonable grounds to believe that the exportation would contravene the laws of the country of final destination 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 export 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.01.053 The holder of an export permit must provide a copy of the permit to the customs office at the time of exportation.

Marginal note:Declaration

J.01.054 The holder of an export permit must provide the Minister, within 15 days after the day of export of the restricted drug specified in the permit, with a declaration that contains the following information:

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

• (b) with respect to the restricted drug,

  • (i) its name, as specified 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 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; and

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

Marginal note:Suspension

• J.01.055 (1) The Minister must suspend an export 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 exportation would contravene the laws of the country of final destination 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 export permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary.

Marginal note:Revocation

• J.01.056 (1) Subject to subsection (2), the Minister must revoke an export 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.01.055(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 export 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 export 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.01.057 If an export 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.

Identification

Marginal note:Name

J.01.058 A licensed dealer must include their name, as set out in their dealer’s licence, on all the means by which they identify themself in regard to their activities in relation to restricted drugs, including labels, orders, shipping documents, invoices and advertising.

Sale of Restricted Drugs

Marginal note:Sale to institution

• J.01.059 (1) Despite section C.08.002 and subject to subsections (3) and (4), a licensed dealer may sell a restricted drug to an institution for one of the following purposes if the institution submits to the dealer or the Minister an application to purchase the drug and the Minister issues a prior written authorization for the sale:

  • (a) clinical testing in the institution by qualified investigators for the purpose of determining the hazards and efficacy of the drug; or

  • (b) laboratory research in the institution by qualified investigators.

• Marginal note:Content of application

  (2) The application must contain the following information:

  • (a) the name and the municipal address of the institution;

  • (b) the names and qualifications of the qualified investigators;

  • (c) the name, form, quantity and strength per unit of the restricted drug being requested;

  • (d) details of the proposed use of the drug; and

  • (e) the name and municipal address of the licensed dealer from whom the institution proposes to purchase the drug.

• Marginal note:Application to licensed dealer

  (3) If the institution submits the application to the licensed dealer, the dealer must provide a copy of it to the Minister.

• Marginal note:Authorization by Minister

  (4) After reviewing the application received from the institution or the copy of it received from the licensed dealer, the Minister may, subject to any terms and conditions that the Minister has reasonable grounds to believe are necessary, authorize in writing

  • (a) the sale by the licensed dealer to the institution of the restricted drug applied for in the form, quantity and strength per unit specified by the Minister; and

  • (b) the possession of the restricted drug by qualified investigators for clinical testing of the drug in the institution for the purpose of determining its hazards and efficacy or to conduct laboratory research with the drug in the institution.

• Marginal note:Authorized use only

  (5) The institution must use the restricted drug only in accordance with the written authorization.

Marginal note:Sale to Minister

J.01.060 A licensed dealer may sell or provide a restricted drug to the Minister.

Marginal note:Provision for identification or analysis

• J.01.061 (1) Despite anything in this Part, a person may, for the purpose of identification or analysis of a restricted drug, provide or deliver it to

  • (a) a practitioner of medicine; or

  • (b) an agent or mandatary of a practitioner of medicine, if the agent or mandatary has been exempted under section 56 of the Act with respect to the possession of that restricted drug for that purpose.

• Marginal note:Agent or mandatary of practitioner of medicine

  (2) An agent or mandatary of a practitioner of medicine who receives the restricted drug must immediately provide or deliver it to

  • (a) the practitioner; or

  • (b) the Minister.

• Marginal note:Practitioner of medicine

  (3) A practitioner of medicine who receives the restricted drug must immediately provide or deliver it

  • (a) for the purpose of its identification or analysis, to a person exempted under section 56 of the Act with respect to the possession of that restricted drug for that purpose; or

  • (b) to the Minister.

Packaging, Labelling and Transportation

Marginal note:Packaging — sale and provision

• J.01.062 (1) A licensed dealer that sells or provides a restricted drug must securely package it in its immediate container, which must be sealed in such a manner that the container cannot be opened without breaking the seal.

• Marginal note:Packaging — transport and export

  (2) A licensed dealer that transports or exports a restricted drug must ensure that its package is sealed in such a manner that the package cannot be opened without breaking the seal.

• Marginal note:Exception

  (3) Subsection (1) does not apply to a test kit that contains a restricted drug and that has a registration number.

Marginal note:Labelling

• J.01.063 (1) A licensed dealer that sells or provides a restricted drug must ensure that its package is labelled so that its inner and outer labels show

  • (a) the proper name or, if there is no proper name, the name of the drug;

  • (b) the net contents of the package;

  • (c) the unit strength of the drug and the number of units per package, if applicable;

  • (d) the lot number of the drug;

  • (e) the expression “Restricted Drug”; and

  • (f) the name and municipal address of the manufacturer or assembler of the drug.

• Marginal note:Exception

  (2) Subsection (1) does not apply to a test kit that contains a restricted drug and that has a registration number.

• Marginal note:Non-application

  (3) The labelling requirements set out in section C.01.004 do not apply to a restricted drug.

Marginal note:Transport

J.01.064 A licensed dealer must, in taking delivery of a restricted drug that they have imported or in making delivery of a restricted drug,

• (a) take any measures that are necessary to ensure the security of the drug while it is being transported;

• (b) use a method of transportation that permits an accurate record to be kept of all handling of the drug as well as of the signatures of every person handling it until it is delivered to the consignee;

• (c) in the case of an imported drug, transport it directly to the site specified in their licence after it is released under the Customs Act; and

• (d) in the case of a drug to be exported, transport it directly from the site specified in their licence to the customs office where it will be exported.