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

Regulations are current to 2022-09-22 and last amended on 2022-07-21. Previous Versions

PART GControlled Drugs (continued)

DIVISION 2Licensed Dealers (continued)

Export Permits (continued)

Marginal note:Issuance

 Subject to section G.02.044, 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 G.02.040(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 controlled drug being diverted to an illicit market or use.

Marginal note:Validity

 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 G.02.047 or G.02.048,

  • (c) the date of the suspension or revocation of the dealer’s licence under section G.02.027 or G.02.028, and

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

Marginal note:Return of permit

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

Marginal note:Refusal

  •  (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 controlled 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 G.02.040(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 controlled 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

 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

 The holder of an export permit must provide the Minister, within 15 days after the day of export of the controlled 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 controlled drug;

  • (b) with respect to the controlled 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 controlled 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 controlled 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 controlled drug was exported and the date of export.

Marginal note:Suspension

  •  (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 controlled 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

  •  (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 G.02.047(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 controlled 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 G.02.028(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 controlled 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

 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

 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 controlled drugs, including labels, orders, shipping documents, invoices and advertising

Sale of Controlled Drugs

Marginal note:Sale to another licensed dealer

 A licensed dealer may sell or provide a controlled drug to another licensed dealer.

Marginal note:Sale to pharmacist

  •  (1) Subject to subsection (2), a licensed dealer may sell or provide a controlled drug to a pharmacist.

  • Marginal note:Exception — pharmacist named in notice

    (2) A licensed dealer must not sell or provide to a pharmacist named in a notice issued under section G.03.017.2 the controlled drugs referred to in the notice unless the dealer has received a notice of retraction issued under section G.03.017.3.

Marginal note:Sale to practitioner

  •  (1) Subject to subsection (2), a licensed dealer may sell or provide a controlled drug to a practitioner.

  • Marginal note:Exception — practitioner named in notice

    (2) A licensed dealer must not sell or provide to a practitioner who is named in a notice issued under section G.04.004.2 the controlled drugs referred to in the notice, unless the dealer has received a notice of retraction issued under section G.04.004.3.

Marginal note:Provision to hospital employee

 A licensed dealer may provide a controlled drug to a hospital employee.

Marginal note:Sale to exempted person

 A licensed dealer may sell or provide a controlled drug to a person who is exempted under section 56 of the Act with respect to the possession of that drug.

Marginal note:Sale to Minister

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

Marginal note:Written order

 A licensed dealer may sell or provide a controlled drug under any of sections G.02.051 to G.02.055 if

  • (a) the dealer has received a written order that specifies the name and quantity of the drug to be supplied and is signed and dated

    • (i) in the case of a drug to be provided to a hospital employee or a practitioner in a hospital, by the pharmacist in charge of the hospital’s pharmacy or by a practitioner authorized by the person in charge of the hospital to sign the order, and

    • (ii) in any other case, by the person to whom the drug is to be sold or provided; and

  • (b) the dealer has verified the signature, if it is unknown to them.

Marginal note:Verbal order

  •  (1) A licensed dealer may sell or provide a controlled drug listed in Part II or III of the schedule to this Part if

    • (a) the dealer has received a verbal order that specifies the name and quantity of the drug to be supplied; and

    • (b) in the case of the provision of the drug to a hospital employee or a practitioner in a hospital, the order has been placed by the pharmacist in charge of the hospital’s pharmacy or by a practitioner authorized by the person in charge of the hospital to place the order.

  • Marginal note:Receipt

    (2) A licensed dealer that has received a verbal order from a pharmacist or practitioner must, within five working days after filling the order, obtain and keep a receipt that includes

    • (a) the signature of the pharmacist or practitioner who received the controlled drug;

    • (b) the date on which the pharmacist or practitioner received the controlled drug; and

    • (c) the name and quantity of the controlled drug.

  • Marginal note:No further sale without receipt

    (3) If the licensed dealer has not obtained the receipt within five working days, the dealer must not sell or provide a controlled drug to the pharmacist or practitioner in accordance with a further verbal order received from them until after obtaining the receipt.

 
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