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Benzodiazepines and Other Targeted Substances Regulations (SOR/2000-217)

Regulations are current to 2022-09-22 and last amended on 2019-12-09. Previous Versions

Documents

Marginal note:Alteration prohibited

 A person must not make any mark on or alter or deface in any manner any licence, permit or registration number issued under these Regulations.

Marginal note:Retention period

 A person must keep any document containing all of the information that they are required to record under these Regulations, including every declaration and a copy of every report, for a period of two years following the day on which the last record is recorded in the document and in a manner that permits an audit of the document to be made at any time.

Marginal note:Location

 The documents must be kept

  • (a) in the case of a licensed dealer, at the site specified in their licence; and

  • (b) in the case of a former licensed dealer or any other person, at a location in Canada.

Marginal note:Quality of documents

 The documents must be complete and readily retrievable and the information in them must be legible and indelible.

Advertising

Marginal note:Restrictions

 It is prohibited to

  • (a) advertise a targeted substance to the general public; or

  • (b) publish any written advertisement respecting a targeted substance unless the advertisement

    • (i) is published in literature distributed to, or in a trade publication for, licensed dealers, pharmacists, practitioners or hospitals, and

    • (ii) displays the following symbol in a clear and conspicuous colour and size in the upper left quarter of its first page:

      The symbol consists of a square outline divided in half from top left corner to bottom right corner. An uppercase letter C appears in the centre of the top right half and an uppercase letter T appears in the centre of the lower left half.

Minister

Marginal note:Notice of prohibition of sale

  •  (1) In the circumstances described in subsection (2), the Minister must send a notice to the persons and authorities specified in subsection (3) advising them that

    • (a) pharmacists practising in the notified pharmacies and all licensed dealers must not sell or provide any targeted substance to the pharmacist or the practitioner named in the notice;

    • (b) pharmacists practising in the notified pharmacies must not fill an order or prescription for any targeted substance provided by the practitioner named in the notice; or

    • (c) the prohibitions in both paragraphs (a) and (b) apply with respect to the practitioner named in the notice.

  • Marginal note:Circumstances requiring a notice

    (2) The notice must be sent if the pharmacist or practitioner named in the notice has

    • (a) made a request to the Minister in accordance with subsection 57(1) or section 62 to send the notice;

    • (b) contravened a rule of conduct established by the provincial professional licensing authority in the province in which the pharmacist or practitioner is practising and the authority has requested the Minister in writing to send the notice; or

    • (c) been convicted of a designated substance offence or of a contravention of these Regulations.

  • Marginal note:Recipients

    (3) The notice must be sent to

    • (a) all licensed dealers;

    • (b) all pharmacies within the province in which the pharmacist or practitioner named in the notice is registered and entitled to practise and is practising;

    • (c) the provincial professional licensing authority of the province in which the pharmacist or practitioner named in the notice is registered and entitled to practise;

    • (d) all pharmacies in an adjacent province in which a prescription or order from the pharmacist or practitioner named in the notice may be filled; and

    • (e) any provincial professional licensing authority in another province that has requested the Minister in writing to send the notice.

  • Marginal note:Other circumstances

    (4) The Minister may send the notice described in subsection (1) to the persons and authorities specified in subsection (3) if the Minister has taken the measures specified in subsection (5) and has reasonable grounds to believe that the pharmacist or practitioner named in the notice

    • (a) has contravened a provision of the Act or these Regulations;

    • (b) has, on more than one occasion, self-administered a targeted substance under a self-directed prescription or order or, in the absence of a prescription or order, contrary to accepted professional practice;

    • (c) has, on more than one occasion, prescribed, administered or provided a targeted substance to a person who is a spouse, common-law partner, parent or child of the pharmacist or practitioner, including a child adopted in fact, contrary to accepted professional practice; or

    • (d) is unable to account for a quantity of targeted substance for which the pharmacist or practitioner was responsible under these Regulations.

  • Marginal note:Measures before sending notice

    (5) The measures that must be taken before sending the notice are that the Minister has

    • (a) consulted with the provincial professional licensing authority of the province in which the pharmacist or practitioner to whom the notice relates is registered and entitled to practise;

    • (b) given that pharmacist or practitioner an opportunity to be heard; and

    • (c) considered

      • (i) the compliance history of the pharmacist or practitioner in respect of the Act and its regulations, and

      • (ii) whether the actions of the pharmacist or practitioner pose a risk to public health or safety, including the risk of the targeted substance being diverted to an illicit market or use.

Marginal note:Prohibition of sale — notice of retraction

 The Minister must provide the persons and authorities who were sent a notice under subsection 79(1) with a notice of retraction of that notice if

  • (a) in the circumstance described in paragraph 79(2)(a), the requirements set out in subparagraphs (b)(i) and (ii) have been met and one year has elapsed since the notice was sent by the Minister; or

  • (b) in the circumstance described in any of paragraphs 79(2)(b) and (c) and (4)(a) to (d), the pharmacist or the practitioner named in the notice has

    • (i) requested in writing that a retraction of the notice be sent, and

    • (ii) provided a letter from the provincial professional licensing authority of the province in which the pharmacist or practitioner is registered and entitled to practise in which the authority consents to the retraction of the notice.

Marginal note:Communication of information by Minister to licensing authority

  •  (1) The Minister must provide in writing any factual information about a pharmacist, practitioner or nurse that has been obtained under the Act or these Regulations to the provincial professional licensing authority that is responsible for the registration and authorization of the person to practise their profession

    • (a) in the province in which the person is or was registered and entitled to practise if

      • (i) the authority submits a written request that sets out the name and address of the person, a description of the information being requested and a statement that the information is required for the purpose of assisting a lawful investigation by the authority, or

      • (ii) the Minister has reasonable grounds to believe that the person has

        • (A) contravened a rule of conduct established by the authority,

        • (B) been convicted of a designated substance offence, or

        • (C) contravened these Regulations; or

    • (b) in a province in which the person is not registered and entitled to practise, if the authority submits to the Minister

      • (i) a written request that sets out the person’s name and address and a description of the information being requested, and

      • (ii) a document that shows that

        • (A) the person has applied to that authority to practise in that province, or

        • (B) the authority has reasonable grounds to believe that the person is practising in that province without being authorized to do so.

  • Marginal note:Definition of nurse

    (2) For the purpose of subsection (1), nurse does not include a nurse practitioner.

Notification of Application for Order of Restoration

Marginal note:Written notification

  •  (1) For the purpose of subsection 24(1) of the Act, notification of an application for an order of restoration must be given in writing to the Attorney General by registered mail and must be mailed not less than 15 days before the date on which the application is to be made to a justice.

  • Marginal note:Content of notification

    (2) The notification must specify

    • (a) the name of the justice to whom the application is to be made;

    • (b) the time and place at which the application is to be heard;

    • (c) details concerning the targeted substance or other thing in respect of which the application is to be made; and

    • (d) the evidence on which the applicant intends to rely to establish that they are entitled to possession of the targeted substance or other thing referred to in paragraph (c).

Permit for Transit or Transhipment

Marginal note:Application

  •  (1) If a targeted substance is to be shipped from a country of export to a foreign country by a route that requires it to be in transit through Canada or to be transhipped in Canada, the exporter in the country of export or their agent or mandatary in Canada must obtain a permit for the transit or transhipment of the targeted substance by submitting to the Minister an application that contains the following information:

    • (a) the name, municipal address and telephone number of the exporter in the country of export;

    • (b) the name, municipal address and telephone number of the person who will be responsible for the targeted substance while it is in Canada;

    • (c) with respect to the targeted substance,

      • (i) its specified name and, if applicable, its brand name,

      • (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;

    • (d) the expected date of transit or transhipment in Canada;

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

    • (f) each proposed mode of transportation in Canada; and

    • (g) in the case of a transhipment, the municipal address of every place in Canada at which the targeted substance will be stored during the transhipment and the expected duration of the storage at each place.

  • Marginal note:Documents

    (2) The application must be accompanied by

    • (a) a copy of the export permit issued by the competent authority in the country of export; and

    • (b) a copy of the import permit issued by the competent authority in the country of final destination.

  • Marginal note:Signature and attestation

    (3) The application must

    • (a) be signed and dated by a person who is authorized for that purpose by the exporter, including an agent or mandatary in Canada of that exporter; 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

    (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

  •  (1) Subject to subsection (2), on completion of the review of the application for a permit for transit or transhipment, the Minister must issue to the applicant a permit for transit or transhipment that contains

    • (a) the name, municipal address and telephone number of the exporter in the country of export;

    • (b) the name, municipal address and telephone number of the person who is responsible for the targeted substance while it is in Canada;

    • (c) the specified name of the targeted substance, its quantity, its purity and, if applicable, its strength per unit, the number of units per package and the number of packages;

    • (d) the countries of export and final destination and the numbers and expiry dates of the export and import permits issued by the competent authority in each of those countries;

    • (e) the expected date of the transit or transhipment in Canada;

    • (f) the name of the customs office where the importation or exportation is anticipated;

    • (g) each proposed mode of transportation in Canada;

    • (h) in the case of a transhipment, the municipal address of every place in Canada at which the targeted substance will be stored during the transhipment and the expected duration of the storage at each place; and

    • (i) the dates of issuance and expiry of the permit.

  • Marginal note:Refusal

    (2) The Minister must refuse to issue a permit for transit or transhipment if the Minister has reasonable grounds to believe that

    • (a) the issuance of the permit

      • (i) would contravene an international obligation,

      • (ii) would contravene the Act, the regulations or another Act of Parliament or a law of the country of export, of the country of final destination or of a country of transit or transhipment, or

      • (iii) would likely create a risk to public health or safety, including the risk of the targeted substance being diverted to an illicit market or use; or

    • (b) the import permit issued by the competent authority in the country of final destination has expired or has been suspended or revoked.

 
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