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

Regulations are current to 2019-07-01 and last amended on 2018-10-17. Previous Versions

Benzodiazepines and Other Targeted Substances Regulations

SOR/2000-217

CONTROLLED DRUGS AND SUBSTANCES ACT

Registration 2000-06-01

Benzodiazepines and Other Targeted Substances Regulations

P.C. 2000-827  2000-06-01

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 55(1) of the Controlled Drugs and Substances ActFootnote a, hereby makes the annexed Benzodiazepines and Other Targeted Substances Regulations (1091).

Interpretation

Marginal note:Definitions

  •  (1) The definitions in this subsection apply in these Regulations.

    Act

    Act means the Controlled Drugs and Substances Act. (Loi)

    adult

    adult means an individual of 18 years of age or older. (adulte)

    advertisement

    advertisement, in respect of a targeted substance, includes any representation by any means for the purpose of promoting, directly or indirectly, the sale or other disposal of the targeted substance. (publicité)

    common-law partner

    common-law partner in relation to an individual, means a person who is cohabiting with the individual in a conjugal relationship, having so cohabited for a period of at least one year. (conjoint de fait)

    Department

    Department means the Department of Health. (ministère)

    designated drug offence

    designated drug offence means

    • (a) an offence against section 39, 44.2, 44.3, 48, 50.2 or 50.3 of the Food and Drugs Act, as those provisions read immediately before May 14, 1997;

    • (b) an offence against section 4, 5, 6, 19.1 or 19.2 of the Narcotic Control Act, as those provisions read immediately before May 14, 1997;

    • (c) an offence under Part I of the Act, except subsection 4(1); and

    • (d) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in paragraphs (a) to (c). (infraction désignée en matière de drogue)

    emergency medical service vehicle

    emergency medical service vehicle means any conveyance authorized under the laws of a province to transport individuals to hospitals and on which emergency medical services are provided. (véhicule de service médical d’urgence)

    export permit

    export permit means a permit issued under section 43. (permis d’exportation)

    hospital

    hospital means a facility that

    • (a) is licensed, approved or designated as a hospital by a province under the laws of the province to provide health care or treatment to persons or animals; or

    • (b) is owned or operated by the government of Canada or of a province and that provides health services. (hôpital)

    import permit

    import permit means a permit issued under section 37. (permis d’importation)

    international obligation

    international obligation means an obligation relative to a targeted substance set out in a convention, treaty or other multilateral or bilateral instrument that Canada has ratified or to which Canada adheres. (obligation internationale)

    licensed dealer

    licensed dealer means the holder of a dealer’s licence issued under these Regulations. (distributeur autorisé)

    midwife

    midwife has the same meaning as in section 1 of the New Classes of Practitioners Regulations. (sage-femme)

    nurse practitioner

    nurse practitioner has the same meaning as in section 1 of the New Classes of Practitioners Regulations. (infirmier praticien)

    package

    package includes anything in which a targeted substance is wholly or partly contained, placed or packed. (emballage)

    pharmacist

    pharmacist means an individual who

    • (a) is registered or otherwise authorized under the laws of a province to practise pharmacy; and

    • (b) is practising pharmacy in that province. (pharmacien)

    podiatrist

    podiatrist has the same meaning as in section 1 of the New Classes of Practitioners Regulations. (podiatre)

    prescription

    prescription means, in respect of a targeted substance, an authorization from a practitioner stating that a specific amount of the targeted substance may be sold or provided for the individual or animal under the practitioner’s care named in the authorization. (ordonnance)

    qualified person in charge

    qualified person in charge means the individual with the qualifications set out in subsection 19(2) who is responsible for supervising the activities carried out by a licensed dealer under a dealer’s licence at the premises specified in the licence. (personne qualifiée responsable)

    Security Directive

    Security Directive means the Directive on Physical Security Requirements for Controlled Substances and Drugs Containing Cannabis, as amended from time to time and published by the Government of Canada on its website. (Directive en matière de sécurité)

    specified name

    specified name means, in respect of a controlled substance included in Schedule 1,

    • (a) the name specified in column 1 of an item of Schedule 2, but, if only the chemical name is specified, means the chemical name specified in column 2 of that item; or

    • (b) if the controlled substance is not specified in Schedule 2, its chemical name and, if available, its common name. (nom spécifié)

    targeted substance

    targeted substance means

    • (a) a controlled substance included in Schedule 1, or a product or compound that contains the controlled substance; or

    • (b) in respect of a midwife, nurse practitioner or podiatrist, a controlled substance included in Schedule 1, or a product or compound that contains the controlled substance, that the midwife, nurse practitioner or podiatrist may prescribe, possess or conduct an activity with, in accordance with section 3 of the New Classes of Practitioners Regulations. (substance ciblée)

    test kit 

    test kit  means a kit

    • (a) that contains

      • (i) a targeted substance, and

      • (ii) a reagent system or buffering agent, or both;

    • (b) that is designed to be used during the course of a chemical or analytical procedure to test for the presence or quantity of a targeted substance for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; and

    • (c) the contents of which are not intended or likely to be consumed by, or administered to, a human or an animal. (nécessaire d’essai)

    transhipment

    transhipment means, in respect of a targeted substance that has been unloaded or in any way removed from the means of transportation by which it came into Canada, its loading or placing on board or within or on the same or any other means of transportation used for its departure from Canada. (transbordement)

  • Marginal note:Destruction of a targeted substance

    (2) For the purpose of these Regulations, a targeted substance is destroyed when it is altered or denatured to such an extent that its consumption is rendered impossible or improbable.

  • SOR/2003-38, s. 2
  • SOR/2010-223, s. 1
  • SOR/2012-230, s. 25
  • SOR/2018-147, s. 30

Destruction

Marginal note:Prohibition

  •  (1) Subject to subsections (2) and 33(1), no person shall destroy a targeted substance other than a targeted substance that has been lawfully sold or provided to an individual for their own use or for the benefit of another individual or an animal under their care.

  • Marginal note:Conditions

    (2) A pharmacist, a practitioner or the individual in charge of a hospital may destroy a targeted substance if

    • (a) before the destruction, the pharmacist, practitioner or individual records information with respect to the destruction, including the name, strength per unit and quantity of the targeted substance to be destroyed;

    • (b) the targeted substance is destroyed using a method of destruction that conforms with all applicable federal, provincial and municipal environmental legislation;

    • (c) the person records the date of destruction;

    • (d) subject to subsection (3), the destruction is witnessed by a pharmacist or a practitioner; and

    • (e) immediately following the destruction, the person who destroyed the targeted substance and the witness referred to in paragraph (d) sign and print their names on a joint statement, indicating that they witnessed the destruction and that the targeted substance destroyed has been altered or denatured to such an extent that its consumption has been rendered impossible or improbable.

  • Marginal note:Open Ampule

    (3) A targeted substance that constitutes the remainder of an open ampule, the partial contents of which have been administered to a patient, may be destroyed by a hospital employee who is a licensed health professional without a witness.

  • SOR/2010-223, s. 2(E)

Advertising

Marginal note:Restrictions

 A person must not

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

  • (b) issue or publish an advertisement for 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 in the upper left quarter of its first page, in a clear manner and in a conspicuous colour and size, the following symbol:

      Symbol for caution, consisting of a square outline divided in half from top left corner to bottom right corner. The top right half has an uppercase letter C inside and lower left half has an uppercase letter T inside.

Class 2 Targeted Substances

Marginal note:Obtaining the targeted substance

  •  (1) A person listed in subsection (2) may possess a targeted substance set out in Part 2 of Schedule 1 if the person has obtained the targeted substance

    • (a) in accordance with these Regulations;

    • (b) in the course of activities performed in connection with the enforcement or administration of any Act or regulations made thereunder; or

    • (c) from a person who is exempt under section 56 of the Act from the application of subsection 5(1) of the Act with respect to that targeted substance.

  • Marginal note:Possession

    (2) The following persons may possess a targeted substance set out in Part 2 of Schedule 1:

    • (a) a person who requires the targeted substance for their business or profession and is

      • (i) a licensed dealer acting in accordance with their licence,

      • (ii) a pharmacist, or

      • (iii) a practitioner who is registered and entitled to practise in the province in which the practitioner has such possession;

    • (b) a practitioner who is registered and entitled to practise in a province other than the province in which the practitioner has such possession and such possession is for emergency medical purposes only;

    • (c) a hospital employee or a practitioner in a hospital and such possession is for the purposes of and in connection with such employment;

    • (d) a person who has obtained the targeted substance for their own use or for the benefit of another person or an animal under their care

      • (i) from a practitioner in the course of treatment for a medical condition, or

      • (ii) from a pharmacist pursuant to a prescription issued or obtained in conformity with these Regulations;

    • (e) a person who has imported the targeted substance in accordance with section 68 for the person’s own use or for the benefit of another person or an animal under their care;

    • (f) a person who is employed as an inspector, an analyst, a peace officer, a member of the Royal Canadian Mounted Police or a member of the technical or scientific staff of a department of the government of Canada or of a province and such possession is for the purposes of and in connection with such employment; or

    • (g) a person who, pursuant to a permit issued under Part 7, is responsible for the targeted substance while it is in transit or in transhipment in Canada.

  • Marginal note:Employees

    (3) A person may possess a targeted substance set out in Part 2 of Schedule 1 if the person is an employee of or is acting as the agent or mandatary for a person referred to in any of paragraphs (2)(a) to (e) and (g), while acting in the course of their employment duties or role as agent or mandatary.

  • Marginal note:Agent or mandatary

    (4) A person may possess a targeted substance set out in Part 2 of Schedule 1 if

    • (a) the person is acting as the agent or mandatary of a person who he or she has reasonable grounds to believe is a person referred to in paragraph (2)(f); and

    • (b) the possession of the targeted substance is for the purpose of assisting the person referred to in paragraph (2)(f) in the administration or enforcement of any Act or regulations made thereunder.

  • Marginal note:Exportation by a licensed dealer

    (5) A licensed dealer may possess a targeted substance set out in Part 2 of Schedule 1 for the purpose of exporting that substance if the licensed dealer has obtained the substance under these Regulations and is licensed to export the targeted substance.

  • Marginal note:Exportation by an individual

    (6) An individual may possess a targeted substance set out in Part 2 of Schedule 1 for the purpose of exporting that substance in accordance with section 69.

  • SOR/2010-223, s. 3(F)
  • SOR/2018-69, s. 78(E)

Security

Marginal note:Verification of identity

 Every person who is requested to fill an order or a prescription for a targeted substance must verify in a reasonable manner the identity of the person who gave the order or issued the prescription if

  • (a) the signature on the order or prescription is not known to the person; or

  • (b) the order or prescription is verbal and the person placing it is not known to the person.

Marginal note:Storage

 Subject to section 59, a person licensed or otherwise authorized under these Regulations to deal in a targeted substance must store the targeted substance in the place used for the purpose of conducting their business or professional practice and in the area in that place where only authorized employees have access, except where the targeted substance is for the person’s own use or for the benefit of another person or animal under their care.

Marginal note:Security and reporting loss or theft

  •  (1) The following persons must take any steps that are necessary to ensure the security of a targeted substance in their possession and any licence or permit in their possession with respect to a targeted substance and must, not later than 10 days after discovery, report to the Minister any loss or theft of a targeted substance or of a licence or permit:

    • (a) a licensed dealer;

    • (b) a pharmacist;

    • (c) a practitioner;

    • (d) the person in charge of a hospital;

    • (e) a person to whom an exemption has been granted under section 56 of the Act; and

    • (f) a person who, pursuant to a permit issued under Part 7, is responsible for the targeted substance while it is in transit or in transhipment in Canada.

  • Marginal note:Security of codes

    (2) Every person who has issued or been issued an identifying code referred to in subsections 27(6) and (7) of the Narcotic Control Regulations must

    • (a) take any steps that are necessary to ensure the security of the code; and

    • (b) report to the Minister, not later than 10 days after discovery, any loss or theft of the code, a machine that is capable of producing a code or a document that discloses the code.

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 of information

 The information or records required by these Regulations must be kept for a period of at least two years after

  • (a) in the case of information, the day that the information was obtained; and

  • (b) in the case of a record, the day that the last transaction was recorded on the record.

General Obligations of the Minister

Marginal note:Notice of refusal or revocation

  •  (1) If the Minister proposes to refuse to issue, amend or renew or proposes to revoke a licence, permit or registration number under these Regulations, the Minister must

    • (a) send a notice to the applicant or to the holder of the licence, permit or registration number together with a written report that sets out the reasons for the refusal or revocation; and

    • (b) give the applicant or holder an opportunity to be heard in respect of the refusal or revocation.

  • Marginal note:Notice of suspension

    (2) The suspension of a licence or permit under these Regulations takes effect as soon as the Minister informs the holder of the licence or permit of the decision to suspend and provides a written report that sets out the reasons for the suspension.

  • Marginal note:Opportunity to be heard

    (3) A person who receives a notice of suspension referred to in subsection (2) may, in the 10 days following the receipt of the notice, provide the Minister with reasons why the suspension of the licence or permit is unfounded.

  • SOR/2010-223, s. 4

Marginal note:Further information

 The Minister may, on receiving an application made under these Regulations, require the submission of any further information that pertains to the information contained in the application and that is necessary for the Minister to process the application.

Marginal note:Inspection of premises

 In order to confirm any information contained in an application for a licence made under these Regulations or an amendment or a renewal of a licence, an inspector may, at a time during normal business hours that is convenient for the applicant and with the reasonable assistance of the applicant, inspect the premises for which the licence, amendment or renewal is requested.

Marginal note:Order to return a seized substance

  •  (1) For the purpose of subsection 24(1) of the Act, notice of application for an order to return a seized substance shall be given in writing to the Attorney General by registered mail.

  • Marginal note:Information

    (2) The notice referred to in subsection (1) shall be mailed not less than 15 clear days prior to the date the application is to be made to a justice and must specify

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

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

    • (c) the targeted substance in respect of which the application is to be made; and

    • (d) the evidence upon which the applicant intends to rely to establish that the applicant is entitled to possession of the targeted substance.

Marginal note:Police enforcement

 Where, pursuant to the Controlled Drugs and Substances Act (Police Enforcement) Regulations, a member of a police force or a person acting under the direction and control of the member is, in respect of the conduct of the member or person, exempt from the application of subsection 4(2) or section 5, 6 or 7 of the Act, the member or person is, in respect of that conduct, exempt from the application of these Regulations.

PART 1Licensed Dealers

Permitted Activities

Marginal note:Activities

  •  (1) Subject to subsection (2), sections 4 and 16 and subsection 33(1), a licensed dealer may

    • (a) possess a targeted substance set out in Part 2 of Schedule 1; and

    • (b) produce, make, assemble, import, export, sell, provide, send, deliver, transport or destroy a targeted substance.

  • Marginal note:Activities limited

    (2) A licensed dealer may carry out an activity set out in subsection (1) if the licensed dealer

    • (a) is licensed to carry on the activity with respect to that targeted substance;

    • (b) carries out the activity in accordance with any conditions set out in the dealer’s licence;

    • (c) sells or provides the targeted substance to

      • (i) another licensed dealer,

      • (ii) a pharmacist,

      • (iii) a practitioner,

      • (iv) a hospital,

      • (v) the Minister, or

      • (vi) a person to whom an exemption relating to the substance has been granted under section 56 of the Act;

    • (d) in the case of a producer of a targeted substance, produces the substance in the quantities and within the periods authorized by the dealer’s licence;

    • (e) in the case of a maker or assembler of a product or compound that contains a targeted substance, but that is not a test kit, sells or provides the product or compound in the strength per unit and the quantity or package size authorized by the dealer’s licence;

    • (f) in the case of the importation of a targeted substance, has an import permit issued under section 37; and

    • (g) in the case of the exportation of a targeted substance, has an export permit issued under section 43.

Marginal note:Order required

  •  (1) Subject to subsection (4), a licensed dealer must not sell or provide a targeted substance to a person referred to in paragraph 15(2)(c) before the licensed dealer has received an order for the substance, either in writing in accordance with subsection (2) or verbally and recorded in accordance with subsection (3), from

    • (a) in the case of a hospital, a pharmacist practising in the hospital or a practitioner authorized to place orders for the substance on behalf of the hospital;

    • (b) in the case of a licensed dealer, a person who is authorized to place an order for the substance on behalf of the licensed dealer; or

    • (c) in any other case, the person to whom the substance is to be sold or provided in accordance with the Act and these Regulations.

  • Marginal note:Written orders

    (2) A written order for a targeted substance must

    • (a) be signed by a person described in any of paragraphs (1)(a) to (c); or

    • (b) in the case of an order transmitted electronically, be encoded in accordance with the requirements set out in subsections 27(6) and (7) of the Narcotic Control Regulations.

  • Marginal note:Verbal orders

    (3) A licensed dealer who receives a verbal order must, before filling the order, record the following information with respect to the order:

    • (a) the date and number of the order;

    • (b) the name and address of the person for whom the order is placed;

    • (c) the brand name of the targeted substance ordered or, if the targeted substance does not have a brand name, the specified name;

    • (d) the quantity and, if applicable, the strength per unit of the targeted substance ordered;

    • (e) the name of the individual placing the order; and

    • (f) the name of the individual recording the order.

  • Marginal note:Supply prohibited

    (4) A licensed dealer must not sell or provide a targeted substance to a pharmacist or practitioner named in a notice issued under section 79, unless the licensed dealer has received a retraction issued under section 80.

  • SOR/2014-260, s. 29(E)

Marginal note:Multiple deliveries

 A licensed dealer must not, in respect of an order for a targeted substance, deliver the order in more than one delivery unless

  • (a) the order for the substance states that the quantity of the substance that was ordered is to be supplied

    • (i) in separate deliveries, which in no case may total more than four, and

    • (ii) at specified intervals or on specified dates; or

  • (b) the licensed dealer has insufficient stock of the substance at the time of receipt of the order, in which case the licensed dealer may supply the quantity of the substance that the licensed dealer has in stock and may deliver the balance afterwards in a single supplementary delivery.

  • SOR/2014-260, s. 30(E)

Eligibility

Marginal note:Eligible persons

 To be eligible to be a licensed dealer, a person must be

  • (a) an individual who ordinarily resides in Canada;

  • (b) a corporation that has its head office in Canada or operates a branch office in Canada; or

  • (c) an individual who occupies a position that includes responsibility for a targeted substance on behalf of a department of the government of Canada or of a province, a police force, a hospital or a university in Canada.

Marginal note:Qualified person in charge

  •  (1) A licensed dealer

    • (a) must employ, at the premises to which the dealer’s licence applies, no more than one qualified person in charge (who may be the licensed dealer) who supervises the activities with respect to the targeted substances set out in the dealer’s licence and who is responsible for ensuring compliance with these Regulations on behalf of the licensed dealer; and

    • (b) may employ an alternate qualified person in charge at that premises who may perform the duties of the qualified person in charge when that person is absent.

  • Marginal note:Qualifications

    (2) The qualified person in charge and, if applicable, the alternate qualified person in charge must

    • (a) be familiar with the provisions of the Act and the regulations that apply to the dealer’s licence held by their employer and have a sufficient knowledge of chemistry and pharmacology and experience in those fields to properly carry out their duties;

    • (b) either

      • (i) be a pharmacist or a practitioner of medicine, dentistry or veterinary medicine, registered with a provincial professional licensing authority, or

      • (ii) possess a degree in an applicable science — such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, organic chemistry or chemical engineering — that is awarded by a Canadian university or, if awarded by a foreign university, that is recognized by a Canadian university or a Canadian professional association; and

    • (c) not have been convicted, as an adult, in the previous 10 years, of

      • (i) in Canada, a designated drug offence, or

      • (ii) in a country other than Canada, an offence that, if committed in Canada, would have constituted a designated drug offence.

  • SOR/2010-223, s. 5
  • SOR/2012-230, s. 26
  • SOR/2014-260, s. 39(F)

Application for a Dealer’s Licence

Marginal note:Information and documents

  •  (1) To apply for a dealer’s licence, a person must submit the following information to the Minister;

    • (a) with respect to the applicant,

      • (i) their name or, if the applicant is a corporation, their corporate name and any other name registered with a province, under which the applicant will carry out the activities set out in its dealer’s licence or will identify itself,

      • (ii) the address, telephone number and, if applicable, the facsimile transmission number and e-mail address of the premises to which the dealer’s licence would apply, and

      • (iii) if different from the address of the premises referred to in subparagraph (ii), the applicant’s mailing address;

    • (b) the name, date of birth and gender of the individual in charge of the premises referred to in subparagraph (a)(ii);

    • (c) with respect to the qualified person in charge and, if applicable, the alternate qualified person in charge at the premises referred to in subparagraph (a)(ii),

      • (i) their name, date of birth and gender,

      • (ii) their academic qualifications, training and work experience relevant to the duties of the qualified person in charge or, if applicable, of the alternate qualified person in charge,

      • (iii) their hours of work,

        • (A) at the premises referred to in subparagraph (a)(ii), and

        • (B) at any other work location,

      • (iv) their title at each work location,

      • (v) the name and title of their immediate supervisor at each work location, and

      • (vi) in the case of a pharmacist or a practitioner, the name of the province in which the person’s current professional licence, certification or authorization was issued and the professional licence, certification or authorization number;

    • (d) a list of the names of the individuals authorized to place an order for a targeted substance on behalf of the applicant;

    • (e) the activities set out in subsection 15(1) for which the licence is sought that would be carried out at the premises to which the dealer’s licence would apply;

    • (f) in the case of a product or compound that contains a targeted substance, but that is not a test kit, that would be made or assembled for or by the applicant, a list that sets out

      • (i) the brand name of each product or compound,

      • (ii) the specified name of the targeted substance in each product or compound,

      • (iii) the strength per unit of the targeted substance in each product or compound,

      • (iv) the quantity or package sizes of each product or compound, and

      • (v) if the product or compound would be made or assembled by or for another licensed dealer under a custom order, the name, address and dealer’s licence number of that other licensed dealer;

    • (g) if the licence is sought to produce a controlled substance included in Schedule 1,

      • (i) the specified name of the substance,

      • (ii) the quantity, other than a product or compound that contains a controlled substance that is included in Schedule 1, that the applicant expects to produce under the dealer’s licence and the period during which that quantity would be produced, and

      • (iii) if the substance would be produced for another licensed dealer under a custom order, the name, address and dealer’s licence number of that other licensed dealer;

    • (h) a description of the security measures, as determined in accordance with the Security Directive, at the applicant’s premises referred to in subparagraph (a)(ii);

    • (i) a description of the method that the applicant proposes to use for recording their targeted substance transactions; and

    • (j) for any activity set out in subsection 15(1), other than the activities described in paragraphs (f) and (g), the specified name of the targeted substance and the purpose for carrying out the activity.

  • Marginal note:Statement by signatory

    (2) An application for a dealer’s licence must

    • (a) be signed by the individual in charge of the premises to which the licence would apply; and

    • (b) include a statement signed by the individual in charge indicating that

      • (i) all information and documents submitted in support of the application are correct and complete to the best of that individual’s knowledge, and

      • (ii) the individual in charge has the authority to bind the applicant.

  • Marginal note:Accompanying documents

    (3) An application for a dealer’s licence must be accompanied by

    • (a) a signed declaration from the individual in charge of the premises, a signed declaration from the qualified person in charge and, if applicable, a signed declaration from the alternate qualified person in charge, stating that they have not been convicted, as an adult, in the previous 10 years, of

      • (i) in Canada, a designated drug offence, and

      • (ii) in a country other than Canada, an offence that, if committed in Canada, would have constituted a designated drug offence;

    • (b) a document issued by a Canadian police force with respect to each of the following individuals, stating whether the person has or has not been convicted, as an adult, in the previous 10 years, of a designated drug offence:

      • (i) the individual in charge of the premises as set out in the application,

      • (ii) the qualified person in charge, and

      • (iii) if applicable, the alternate qualified person in charge;

    • (c) if the individual in charge of the premises, the qualified person in charge or, if applicable, the alternate qualified person in charge has ordinarily resided in a country other than Canada in the previous 10 years, a document issued by a police force of that country stating whether the person has or has not been convicted, as an adult, in the previous 10 years, of an offence that, if committed in Canada, would have constituted a designated drug offence;

    • (d) a statement, signed and dated by the individual in charge of the premises, stating that the qualified person in charge and, if applicable, the alternate qualified person in charge have the knowledge and experience set out in paragraph 19(2)(a);

    • (e) if the qualified person in charge or, if applicable, the alternate qualified person in charge is not a pharmacist or a practitioner of medicine, dentistry or veterinary medicine authorized or entitled to practise by a provincial professional licensing authority, a copy of the person’s degree referred to in subparagraph 19(2)(b)(ii);

    • (f) where the applicant’s name appears on the label of a product or compound that contains a targeted substance, a copy of the inner label, as defined in section A.01.010 of the Food and Drug Regulations, for each product or compound to which the licence would apply; and

    • (g) if the applicant is a corporation, a copy of

      • (i) the certificate of incorporation or other constituting instrument, and

      • (ii) any document filed with the province in which the premises to which the licence would apply is located that states its corporate name or any other name registered with the province, under which the applicant will carry out the activities set out in its dealer’s licence or will identify itself.

  • Marginal note:Recording Method

    (4) The method proposed by the applicant under paragraph (1)(i) must

    • (a) be capable of accounting for all targeted substances, including the strength of each targeted substance per unit in each product or compound and the number of doses in each container of a targeted substance, in the possession of the licensed dealer as required under section 35; and

    • (b) permit the Minister to audit the activities of the licensed dealer with respect to targeted substances.

  • SOR/2010-223, ss. 6, 42(E)
  • SOR/2012-230, s. 27
  • SOR/2014-260, ss. 31, 39(F)

Issuance of a Dealer’s Licence

Marginal note:Content of licence

 Subject to section 22, the Minister must, after examining the information and documents required under sections 11 and 20, issue a dealer’s licence that sets out the following particulars:

  • (a) the licence number;

  • (b) the name of the licensed dealer or, if the licensed dealer is a corporation, its corporate name;

  • (c) the activities that are permitted and, if the licence authorizes destruction, whether the licensed dealer may destroy targeted substances other than those that the licensed dealer produced, made, assembled, sold or provided;

  • (d) the address of the premises at which the licensed dealer may carry on the permitted activities;

  • (e) the targeted substance for which the activities are permitted;

  • (f) the security level and the applicable inventory limitation required at the premises referred to in paragraph (d);

  • (g) the date of issuance;

  • (h) the date of expiry;

  • (i) any conditions that are necessary to

    • (i) comply with an international obligation,

    • (ii) provide the level of security referred to in paragraph (f), or

    • (iii) reduce the potential security, public health or safety hazard, including the risk of the targeted substance being diverted to an illicit market or use;

  • (j) in the case of a producer of a targeted substance, the quantity of the targeted substance that may be produced under the licence and the period in which that quantity may be produced; and

  • (k) in the case of the maker or assembler of a product or compound that contains a targeted substance, but that is not a test kit, an annexed list that sets out the following information for each type of product or compound that may be made or assembled under the licence:

    • (i) the licence number,

    • (ii) the brand name of each product or compound,

    • (iii) the specified name of the targeted substance in each product or compound,

    • (iv) the strength per unit of the targeted substance in each product or compound, and

    • (v) the quantity or package sizes of each product or compound.

  • SOR/2010-223, s. 43(F)
  • SOR/2014-260, s. 32

Grounds for Refusal

Marginal note:Refusal of the Minister

 The Minister must refuse to issue, renew or amend a dealer’s licence in the following cases:

  • (a) the applicant is not an eligible person described in section 18;

  • (b) an inspector, who has requested an inspection, has not been given the opportunity by the applicant to conduct an inspection under section 12;

  • (c) false or misleading information or false or falsified documents were submitted in or with the application;

  • (d) an activity for which the licence is requested would contravene an international obligation;

  • (e) information received from a competent authority of a country other than Canada or the United Nations raises a reasonable belief that the applicant has contravened an international obligation;

  • (f) the applicant does not have in place the security measures set out in the Security Directive in respect of an activity for which the licence is requested;

  • (g) the applicant is in contravention of or has contravened in the past 10 years

    • (i) a provision of the Act or any regulations made or continued under the Act, or

    • (ii) a term or condition of another dealer’s licence or an import or export permit issued to it under any regulations made or continued under the Act;

  • (h) the issuance, renewal or amendment of the licence would likely create a risk to security, public health or safety, including the risk of the targeted substance being diverted to an illicit market or use;

  • (i) the individual in charge of the premises, the qualified person in charge or, if applicable, the alternate qualified person in charge has been convicted, as an adult, in the previous 10 years, of

    • (i) in Canada, a designated drug offence, or

    • (ii) in a country other than Canada, an offence that, if committed in Canada, would have constituted a designated drug offence;

  • (j) the proposed method of record keeping referred to in paragraph 20(1)(i) is not capable of accounting for the applicant’s targeted substance transactions as required under section 35 or permitting the Minister to audit the applicant’s activities with respect to targeted substances in a timely manner; or

  • (k) the information required under section 11 has not been provided or is insufficient to process the application.

  • SOR/2010-223, s. 7

Expiration

Marginal note:Duration of dealer’s licence

 A dealer’s licence expires on December 31 of the calendar year for which it is issued.

Application for Renewal

Marginal note:Renewal of dealer’s licence

  •  (1) To apply to renew a dealer’s licence, the licensed dealer must submit to the Minister

    • (a) the information set out in paragraphs 20(1)(a) to (j); and

    • (b) the following documents:

      • (i) the documents referred to in paragraphs 20(3)(a), (b) and (d),

      • (ii) if applicable and if not previously submitted in respect of the dealer’s licence that is being renewed, the document referred to in paragraph 20(3)(e), and

      • (iii) the original dealer’s licence that is to be renewed.

  • Marginal note:Statement by signatory

    (2) An application for renewal must

    • (a) be signed by the individual in charge of the premises to which the renewed dealer’s licence would apply; and

    • (b) include a statement signed by the individual in charge indicating that

      • (i) all information and documents submitted in support of the application are correct and complete to the best of their knowledge, and

      • (ii) the individual in charge has the authority to bind the applicant.

  • Marginal note:Issuance of renewal

    (3) Subject to section 22, the Minister must, after examining the information and documents required under subsections (1) and (2) and section 11, issue a renewed dealer’s licence that contains the information set out in paragraphs 21(a) to (k).

  • SOR/2010-223, s. 42(E)

Amendment of Dealer’s Licence

Marginal note:Application for amendment

  •  (1) To have the content of its dealer’s licence amended, a licensed dealer must submit to the Minister

    • (a) a written application setting out the amendment sought and, if applicable, the documents that support the amendment; and

    • (b) the original dealer’s licence that the licensed dealer seeks to have amended.

  • Marginal note:Statement by signatory

    (2) An application for amendment must

    • (a) be signed by the qualified person in charge or, if applicable, the alternate qualified person in charge of the premises to which the amended dealer’s licence would apply; and

    • (b) indicate that all information and documents submitted in support of the application are correct and complete to the best of the signatory’s knowledge.

  • Marginal note:Issuance

    (3) The Minister

    • (a) must, after examining the application for amendment and the supporting documentation, amend the dealer’s licence in accordance with the application, unless there exists a circumstance described in section 22; and

    • (b) may add any conditions that are necessary to

      • (i) comply with an international obligation,

      • (ii) provide for the level of security referred to in paragraph 21(f) or the new level applicable as a result of the amendment being implemented, or

      • (iii) reduce the potential security, public health or safety hazard, including the risk of the targeted substance being diverted to an illicit market or use.

  • SOR/2010-223, ss. 8, 42(E), 43(F)

Changes in Information Provided

Marginal note:Prior approval or notice

  •  (1) A licensed dealer must

    • (a) obtain the Minister’s approval before making any of the following changes:

      • (i) a change relating to the security at the premises referred to in the dealer’s licence, or

      • (ii) the replacement or the addition of

        • (A) an individual in charge of the premises to which the dealer’s licence applies,

        • (B) a qualified person in charge and, if applicable, an alternate qualified person in charge at the premises to which the dealer’s licence applies, and

        • (C) a person authorized to place an order for a targeted substance on behalf of the licensed dealer;

    • (b) notify the Minister, not later than 10 days after the event, when a person referred to in any of clause (a)(ii)(A) or (C) ceases to carry out their duties as set out in

      • (i) the application for a dealer’s licence under section 20,

      • (ii) the application to renew a dealer’s licence under section 24, or

      • (iii) the request for approval under paragraph (a); and

    • (c) notify the Minister, not later than the next business day after the event, when a person referred to in clause (a)(ii)(B) ceases to carry out their duties as set out in

      • (i) the application for a dealer’s licence under section 20,

      • (ii) the application to renew a dealer’s licence under section 24, or

      • (iii) the request for approval under paragraph (a).

  • Marginal note:New personnel

    (2) The licensed dealer must, with the request for approval referred to in subparagraph (1)(a)(ii), provide the Minister with the following information and documents with respect to the new person:

    • (a) in the case of the replacement of the individual in charge of the premises to which the dealer’s licence applies,

      • (i) the information specified in paragraph 20(1)(b), and

      • (ii) the documents specified in paragraphs 20(3)(a) to (c);

    • (b) in the case of the replacement of the qualified person in charge or the replacement or addition of an alternate qualified person in charge at the premises to which the dealer’s licence applies,

      • (i) the information specified in paragraph 20(1)(c), and

      • (ii) the documents specified in paragraphs 20(3)(a) to (e); and

    • (c) in the case of the replacement or addition of an individual who is authorized to place an order for a targeted substance on behalf of the licensed dealer, the individual’s name.

  • SOR/2010-223, s. 9(F)
  • SOR/2014-260, s. 39(F)

Revocation or Suspension of Dealer’s Licence

Marginal note:Revocation

 The Minister must revoke a dealer’s licence at the request of the licensed dealer or on being notified by the licensed dealer that the licence has been lost or stolen.

  • SOR/2014-260, s. 40(F)

Marginal note:Other revocation circumstances

  •  (1) Subject to subsection (2), the Minister must revoke a dealer’s licence in accordance with subsection 10(1) in the following circumstances:

    • (a) the licence was issued on the basis of false or misleading information or false or falsified documents submitted in or with the application;

    • (b) the licensed dealer has failed to comply with a provision of the Act or the regulations or a term or condition of the licence or of an import or export permit issued under these Regulations;

    • (c) the licensed dealer is no longer an eligible person under section 18; or

    • (d) it has been discovered that the individual in charge of the premises to which the licence applies, the qualified person in charge or, if applicable, the alternate qualified person in charge at those premises has been convicted, as an adult, in the previous 10 years, of

      • (i) in Canada, a designated drug offence, or

      • (ii) in a country other than Canada, an offence that, if committed in Canada, would have constituted a designated drug offence.

  • Marginal note:Exceptions

    (2) Unless it is necessary to protect security, public health or safety, including preventing the targeted substance from being diverted to an illicit market or use, the Minister must not revoke a dealer’s licence in the circumstances described in paragraph (1)(a) or (b) if

    • (a) the licensed dealer has no history of non-compliance with the Act and the regulations made or continued under it; and

    • (b) the licensed dealer has carried out, or signed an undertaking to carry out, corrective measures to ensure compliance with the Act and these Regulations.

  • SOR/2010-223, s. 10
  • SOR/2014-260, ss. 39(F), 40(F)

Marginal note:Suspension

 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 security, public health or safety, including preventing the targeted substance from being diverted to an illicit market or use.

  • SOR/2010-223, s. 11

General Obligations of Licensed Dealers

Marginal note:Identification

 A licensed dealer must include its name, as set out in its dealer’s licence, on all the means by which it identifies itself in relation to the targeted substance, including advertising, product labels, orders, shipping documents and invoices.

  • SOR/2010-223, s. 12(E)

Marginal note:Safekeeping during transportation

 A licensed dealer must, when transporting an imported targeted substance between the port of entry and the premises set out in its licence, or when sending, delivering or transporting any targeted substance, including to a port of exit, take any steps that are necessary to ensure its safekeeping during transportation.

  • SOR/2010-223, s. 13

Marginal note:Qualified person present

 A licensed dealer must not complete a transaction involving a targeted substance unless the qualified person in charge or, if applicable, the alternate qualified person in charge is physically present at the premises set out in the dealer’s licence.

Marginal note:Destruction procedures

  •  (1) A licensed dealer may destroy a targeted substance that it produced, made, assembled, sold or provided or, where authorized by its dealer’s licence, any other targeted substance if

    • (a) before destroying the substance, the licensed dealer obtains the Minister’s approval for the destruction in accordance with subsection 34(3); and

    • (b) the substance is destroyed in the presence of at least two employees of the licensed dealer qualified to witness the destruction, one of whom must be the qualified person in charge or, if applicable, the alternate qualified person in charge at the premises specified in the dealer’s licence.

  • Marginal note:Witness to destruction

    (2) An employee of the licensed dealer is qualified to witness the destruction if the employee

    • (a) is the qualified person in charge or, if applicable, the alternate qualified person in charge at the premises specified in the dealer’s licence;

    • (b) has sufficient knowledge of chemistry or pharmacology and experience in those fields to be able to confirm that the targeted substance listed in the application for the Minister’s approval has been destroyed, and whose duties for the licensed dealer do not include the receiving, preparing or shipping of targeted substances; or

    • (c) is a senior management officer of the licensed dealer.

  • Marginal note:Transportation of the targeted substance

    (3) If the targeted substance is to be destroyed at a location other than the premises specified in the dealer’s licence, the qualified person in charge or, if applicable, the alternate qualified person in charge at the premises specified in the dealer’s licence must accompany the targeted substance to the location at which it is to be destroyed.

  • SOR/2014-260, s. 39(F)

Marginal note:Application for approval to destroy

  •  (1) To apply for the Minister’s approval to destroy a targeted substance, a licensed dealer must submit the following information to the Minister:

    • (a) the proposed date of destruction;

    • (b) the location of destruction;

    • (c) a brief outline of the method of destruction;

    • (d) the names and qualifications of the witnesses;

    • (e) a list of the targeted substances to be destroyed, including the specified name and, if applicable, the brand name;

    • (f) the strength per unit, form and quantity of each targeted substance to be destroyed, including, if applicable, the number of units per package and the number of packages; and

    • (g) the name, address and licence number of the licensed dealer.

  • Marginal note:Statement by signatory

    (2) An application for the Minister’s approval for the destruction of a targeted substance must

    • (a) be signed by the qualified person in charge or, if applicable, the alternate qualified person in charge at the premises specified in the dealer’s licence;

    • (b) include a statement indicating that the proposed method of destruction conforms with all applicable federal, provincial and municipal environmental legislation in the location where the targeted substance is to be destroyed; and

    • (c) indicate that all information submitted in support of the application is correct and complete to the best of the signatory’s knowledge.

  • Marginal note:Approval by Minister

    (3) The Minister must approve the destruction of the targeted substance unless the Minister has reasonable grounds to believe that

    • (a) false or misleading information or false or falsified documents have been submitted in or with the application;

    • (b) a proposed witness is not qualified under subsection 33(2);

    • (c) the targeted substance or a portion of it is required for the purposes of a criminal or administrative investigation, or any preliminary inquiry, trial or other proceeding under any Act or regulations thereunder;

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

    • (e) the targeted substance will not be destroyed within the meaning of subsection 1(2).

  • SOR/2010-223, ss. 14, 42(E)
  • SOR/2014-260, s. 39(F)

Records, Books, Electronic Data and Other Documents

Marginal note:Required information

 Every licensed dealer must keep, at the premises set out in the dealer’s licence, records, books, electronic data and other documents that contain the following information:

  • (a) for each targeted substance transaction, the date of the transaction, the specified name and the quantity of the targeted substance received, produced, made, assembled, imported, purchased, exported, sold, provided, sent, delivered, transported or destroyed, as the case may be;

  • (b) if the targeted substance is

    • (i) produced, made or assembled, the quantity produced, made or assembled and, if applicable, the strength per unit of the substance, the number of units per package and the number of packages,

    • (ii) received or purchased, the name and address of the provider or seller,

    • (iii) imported, the name and address of the exporter and the country of export and any country of transit or transhipment,

    • (iv) sold, provided, sent, delivered or transported, the name and address of the purchaser or recipient,

    • (v) exported, the name and address of the importer, the country of final destination and any country of transit or transhipment, or

    • (vi) destroyed, the name and address of the qualified person in charge or, if applicable, the alternate qualified person in charge who supervised the destruction and the names and addresses of the other witnesses who attended at the destruction; and

  • (c) a statement signed and dated by each witness stating that they have witnessed the destruction and that the targeted substances were destroyed in accordance with these Regulations and the Minister’s approval for the destruction.

  • SOR/2010-223, s. 15(E)

Importation

Application for an Import Permit

Marginal note:Required information and documents

  •  (1) To apply for a permit to import a targeted substance, a licensed dealer must submit the following information to the Minister:

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

    • (b) with respect to the targeted substance to be imported,

      • (i) its specified name,

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

      • (iii) if applicable, its brand name,

      • (iv) the quantity to be imported,

      • (v) in the case of a raw material, its purity, and

      • (vi) if applicable, its anhydrous content;

    • (c) the name and address of the exporter in the country of export from whom the targeted substance is being obtained;

    • (d) the port of entry;

    • (e) the address of the customs office, sufferance warehouse or bonded warehouse to which the shipment is to be delivered; and

    • (f) each mode of transportation used, the country of export and, if applicable, any country of transit or transhipment.

  • Marginal note:Statement by signatory

    (2) An application for an import permit must

    • (a) be signed by the qualified person in charge or, if applicable, the alternate qualified person in charge at the premises to which the targeted substance will be transported directly after clearing customs; and

    • (b) indicate that all information submitted in support of the application is correct and complete to the best of the signatory’s knowledge.

  • SOR/2010-223, ss. 16, 42(E)

Issuance of an Import Permit

Marginal note:Content of permit

  •  (1) Subject to section 38, the Minister must, after examining the information and documents required under sections 11 and 36, issue to the licensed dealer an import permit that sets out the following particulars:

    • (a) the permit number;

    • (b) the information set out in paragraphs 36(1)(a) to (f);

    • (c) the date of issuance;

    • (d) the date of expiry, which shall be the earliest of

      • (i) 120 days after the permit is issued, and

      • (ii) December 31 of the year in which the permit is issued; and

    • (e) any conditions that are necessary to

      • (i) comply with an international obligation, or

      • (ii) reduce the potential security, public health or safety hazard, including the risk of the targeted substance being diverted to an illicit market or use.

  • Marginal note:Duration of permit

    (2) An import permit is valid until the earliest of:

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

    • (b) the expiry of the dealer’s licence that pertains to the permit;

    • (c) the suspension or revocation under section 27, 28 or 29 of the dealer’s licence that pertains to the permit;

    • (d) the suspension or revocation of the permit under section 41; and

    • (e) the expiry, suspension or revocation of the export permit that applies to the targeted substance to be imported and that is issued by a competent authority in the country of export.

  • SOR/2010-223, ss. 17, 43(F)

Marginal note:Refusal of permit

 The Minister must refuse to issue an import permit if

  • (a) with respect to the application for the permit, there exists a circumstance described in any of paragraphs 22(c) to (f) or (h), with any modifications that the circumstances require;

  • (b) the applicant does not hold a dealer’s licence for the targeted substance that is to be imported or holds a dealer’s licence that will expire before the date of importation;

  • (c) the applicant has been notified in accordance with paragraph 10(1)(a) that one of the following applications submitted by the applicant with respect to the dealer’s licence under which the targeted substance would be imported is to be refused under section 22:

    • (i) an application under section 20 for a dealer’s licence,

    • (ii) an application under section 24 to renew a dealer’s licence, or

    • (iii) an application under section 25 for the amendment of a dealer’s licence; or

  • (d) the Minister has reasonable grounds to believe that

    • (i) the shipment for which the permit is requested would contravene the laws of the country of export or any country of transit or transhipment, or

    • (ii) the importation is for the purpose of re-exporting the targeted substance without having added any economic value to it in Canada.

  • SOR/2010-223, s. 18

Provision of Copy

Marginal note:Copy of the permit

 The holder of an import permit for a targeted substance must provide a copy of the permit to the customs office, sufferance warehouse or bonded warehouse, as the case may be, at the port of entry at the time of importation.

Declaration

Marginal note:Required information

 The holder of an import permit must provide the Minister, within 15 days after the day of release, in accordance with the Customs Act, in Canada of a shipment that contains a targeted substance, with a declaration that contains the following information:

  • (a) the name of the licensed dealer and the numbers of the dealer’s licence and import permit with respect to the shipment;

  • (b) the date of release of the shipment;

  • (c) the specified name or brand name of the targeted substance received; and

  • (d) the quantity and, if applicable, the strength per unit of the targeted substance received.

Revocation or Suspension of an Import Permit

Marginal note:Revocation

  •  (1) The Minister must revoke an import permit at the request of the holder or if the holder informs the Minister that the permit has been lost or stolen.

  • Marginal note:Other revocation circumstances

    (2) Subject to subsection (3), the Minister must revoke an import permit in accordance with subsection 10(1) in the following circumstances:

    • (a) there exists a circumstance described in any of paragraphs 28(1)(a) to (d) with respect to the dealer’s licence under which the targeted substance would be imported; or

    • (a.1) the import permit was issued on the basis of false or misleading information or false or falsified documents submitted in or with the application for the permit;

    • (b) the importation is for the purpose of re-exporting the targeted substance without having added any economic value to it in Canada.

  • Marginal note:Exceptions

    (3) Unless it is necessary to do so to protect security, public health or safety, including preventing the targeted substance from being diverted to an illicit market or use, the Minister must not revoke an import permit in the circumstances described in paragraph (2)(a.1), 28(1)(a) or 28(1)(b) if the holder of the permit meets the conditions referred to in paragraphs 28(2)(a) and (b), with any modifications that the circumstances require.

  • Marginal note:Suspension without prior notice

    (4) The Minister must suspend an import permit without prior notice if

    • (a) the permit holder’s dealer’s licence that applies to the targeted substance being imported has expired or has been suspended or revoked;

    • (b) the Minister has reasonable grounds to believe that it is necessary to do so to protect security, public health or safety including preventing the targeted substance from being diverted to an illicit market or use; or

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

  • SOR/2010-223, s. 19

Exportation

Application for an Export Permit

Marginal note:Required information and documents

  •  (1) To apply for a permit to export a targeted substance, a licensed dealer must submit the following information to the Minister:

    • (a) their name, address and licence number;

    • (b) with respect to the targeted substance to be exported,

      • (i) its specified name,

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

      • (iii) if applicable, its brand name,

      • (iv) the quantity to be exported,

      • (v) in the case of a raw material, its purity, and

      • (vi) if applicable, its anhydrous content;

    • (c) the name and address of the importer in the country of final destination;

    • (d) the port of exit and, if applicable, any country of transit or transhipment;

    • (e) the address of the customs office, sufferance warehouse or bonded warehouse at which the shipment is to be presented for export;

    • (f) each mode of transportation used; and

    • (g) a statement that, to the best of their knowledge, the shipment does not contravene any requirement of the laws of the country of final destination or any country of transit or transhipment.

  • Marginal note:Accompanying document

    (2) An application for an export permit for a targeted substance must be accompanied by a copy of the import permit issued by a competent authority in the country of final destination that sets out the name and the address of the premises of the importer in the country of final destination.

  • Marginal note:Statement by signatory

    (3) An application for an export permit must

    • (a) be signed by the qualified person in charge or the alternate qualified person in charge at the premises from which the targeted substance will be sent to the port of exit; and

    • (b) indicate that all information submitted in support of the application is correct and complete to the best of the signatory’s knowledge.

  • SOR/2010-223, ss. 20, 42(E)

Issuance of an Export Permit

Marginal note:Content of permit

  •  (1) Subject to section 44, the Minister must, after examining the information and documents required under sections 11 and 42, issue an export permit to the licensed dealer that sets out the following particulars:

    • (a) the permit number;

    • (b) the information set out in paragraphs 42(1)(a) to (f);

    • (c) the date of issuance;

    • (d) the date of expiry, which shall be the earliest of

      • (i) 180 days after the permit is issued,

      • (ii) December 31 of the year in which the permit is issued, and

      • (iii) the expiry date of the import permit issued by a competent authority in the country of final destination; and

    • (e) any conditions that are necessary to

      • (i) comply with an international obligation, or

      • (ii) reduce the potential security, public health or safety hazard, including the risk of the targeted substance being diverted to an illicit market or use.

  • Marginal note:Duration of permit

    (2) An export permit is valid until the earliest of:

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

    • (b) the expiry of the dealer’s licence that pertains to the permit;

    • (c) the suspension or revocation under section 27, 28 or 29 of the dealer’s licence that pertains to the permit;

    • (d) the suspension or revocation of the permit under section 47; and

    • (e) the expiry, suspension or revocation of the import permit that applies to the targeted substance to be exported and that is issued by a competent authority in the country of final destination.

  • SOR/2010-223, ss. 21, 43(F)

Marginal note:Refusal of permit

 The Minister must refuse to issue an export permit if

  • (a) with respect to the application for the permit, there exists a circumstance described in any of paragraphs 22(c) to (e) or (h), with any modifications that the circumstances require;

  • (b) the applicant does not hold a dealer’s licence for the targeted substance to be exported or holds a dealer’s licence that will expire before the date of export;

  • (c) the applicant has been notified in accordance with paragraph 10(1)(a) that one of the following applications submitted by the applicant with respect to the dealer’s licence under which the targeted substance would be exported is to be refused under section 22:

    • (i) an application made under section 20 for a dealer’s licence,

    • (ii) an application made under section 24 to renew a dealer’s licence, or

    • (iii) an application made under section 25 for the amendment of a dealer’s licence;

  • (d) the Minister has reasonable grounds to believe that the shipment for which the permit is requested would contravene a requirement of the laws of the country of final destination or any country of transit or transhipment; or

  • (e) the shipment would not be in conformity with the import permit issued by a competent authority of the country of final destination.

  • SOR/2010-223, s. 22

Provision of Copy

Marginal note:Copy of the permit

 The holder of an export permit for a targeted substance must provide a copy of the permit to the customs office, sufferance warehouse or bonded warehouse, as the case may be, at the port of exit at the time of exportation.

Declaration

Marginal note:Required information

 The holder of an export permit must provide the Minister, within 15 days after the day of export of a shipment that contains a targeted substance, with a declaration that contains the following information:

  • (a) the name of the licensed dealer and the numbers of the dealer’s licence and export permit with respect to the shipment;

  • (b) the date of export;

  • (c) the specified name or brand name of the exported targeted substance; and

  • (d) the quantity and, if applicable, the strength per unit of the exported targeted substance.

Revocation or Suspension of an Export Permit

Marginal note:Revocation

  •  (1) The Minister must revoke an export permit at the request of the holder or if the holder informs the Minister that the permit has been lost or stolen.

  • Marginal note:Other revocation circumstances

    (2) Subject to subsection (3), the Minister must revoke an export permit in accordance with subsection 10(1) in the following circumstances:

    • (a) there exists a circumstance described in any of paragraphs 28(1)(a) to (d) with respect to the dealer’s licence under which the targeted substance would be exported; or

    • (b) the export permit was issued on the basis of false or misleading information or false or falsified documents submitted in or with the application;

  • Marginal note:Exceptions

    (3) Unless it is necessary to do so to protect security, public health or safety, including preventing the targeted substance from being diverted to an illicit market or use, the Minister must not revoke an export permit in the circumstances described in paragraph (2)(b), 28(1)(a) or 28(1)(b) if the holder of the permit meets the conditions referred to in paragraphs 28(2)(a) and (b) with any modifications that the circumstances require.

  • Marginal note:Suspension without prior notice

    (4) The Minister must suspend an export permit without prior notice if

    • (a) the permit holder’s dealer’s licence that applies to the targeted substance being exported has expired or has been suspended or revoked;

    • (b) the Minister has reasonable grounds to believe that it is necessary to do so to protect security, public health or safety including preventing the targeted substance from being diverted to an illicit market or use;

    • (c) the exportation is not in conformity with an import permit issued by a competent authority of the country of final destination; or

    • (d) the exportation would contravene the laws of the country of final destination or any country of transit or transhipment.

  • SOR/2010-223, s. 23
  • SOR/2014-260, s. 33(F)

PART 2Pharmacists

Permitted Activities

Marginal note:Application

 This Part, other than section 57, does not apply to a pharmacist when practising in a hospital.

  • SOR/2014-260, s. 34(F)

Marginal note:Authorization

 A pharmacist may, in accordance with this Part, compound a targeted substance pursuant to a prescription.

Marginal note:Record of receipt from licensed dealer

 If a pharmacist receives a targeted substance from a licensed dealer, a pharmacist in another pharmacy or a hospital, the pharmacist must keep a record of the following information:

  • (a) the brand name of the targeted substance received or, if the targeted substance does not have a brand name, the specified name;

  • (b) the quantity and strength per unit of the targeted substance received, the number of units per package and the number of packages;

  • (c) the name and address of the licensed dealer, pharmacist or hospital that supplied it; and

  • (d) the date on which it was received.

  • SOR/2014-260, s. 39(F)

Marginal note:Prescription required

  •  (1) In addition to the activities authorized under section 55, a pharmacist may, subject to section 52, sell, provide, send, deliver or transport a targeted substance to or for an individual or for the benefit of an animal if

    • (a) the pharmacist sells or provides the substance in a container labelled in accordance with subsection (2);

    • (b) the transaction is made pursuant to a prescription

      • (i) dated and signed by a practitioner,

      • (ii) provided verbally to the pharmacist by a practitioner, or

      • (iii) transferred to the pharmacist under subsection 54(1) in accordance with subsection 54(2);

    • (c) the pharmacist has not transferred the prescription to another pharmacist; and

    • (d) when the prescription has been provided verbally, the transaction is recorded by the pharmacist in accordance with subsection (3).

  • Marginal note:Labelling required

    (2) A pharmacist who sells or provides a targeted substance to an individual must do so in a container that is labelled with the following information:

    • (a) the name and address of the pharmacy or pharmacist;

    • (b) the date of issuance of the prescription and the number given to it by the pharmacist;

    • (c) the name of the individual or animal for whose benefit the targeted substance is sold or provided;

    • (d) the name of the practitioner who issued the prescription;

    • (e) the specified name or brand name of the targeted substance;

    • (f) the quantity and, if applicable, the strength per unit of the targeted substance; and

    • (g) the directions for use specified by the practitioner.

  • Marginal note:Record of verbal prescription

    (3) A pharmacist who receives a verbal prescription for a targeted substance must, before filling it,

    • (a) record the following information:

      • (i) the name and address of the individual or animal for whose benefit the prescription is provided,

      • (ii) the date that the verbal prescription was provided,

      • (iii) the specified name or brand name of the targeted substance, as specified in the prescription,

      • (iv) the quantity and, if applicable, the strength per unit of the targeted substance,

      • (v) the name of the recording pharmacist and the name of the practitioner who issued the prescription,

      • (vi) the directions for use specified by the practitioner, and

      • (vii) if the prescription is to be refilled, the number of times it may be refilled and, if specified, the interval between refills; and

    • (b) keep a hard copy or create a written record of the prescription.

  • SOR/2010-223, s. 24

Marginal note:Refills

 A pharmacist may only refill a prescription for a targeted substance if

  • (a) the practitioner who prescribed it expressly directs that the prescription may be refilled and specifies the number of refills;

  • (b) the pharmacist makes a record of each refill in accordance with section 53;

  • (c) less than one year has elapsed since the day on which the prescription was issued by the practitioner;

  • (d) at least one refill remains on the prescription; and

  • (e) in the case where an interval between refills has been specified by the practitioner, it has expired.

Marginal note:Records

 A pharmacist who fills or refills a prescription for a targeted substance must record the following information:

  • (a) the date the prescription was filled or refilled;

  • (b) the quantity of the targeted substance provided at the original filling and at each refill;

  • (c) the pharmacist’s name or initials; and

  • (d) the number assigned to the prescription.

Marginal note:Transfer of prescription

  •  (1) A pharmacist may transfer a prescription for a targeted substance to another pharmacist, except a prescription that has already been transferred.

  • Marginal note:Additional information

    (2) Before a pharmacist sells or provides a targeted substance to an individual under a prescription transferred under subsection (1), the pharmacist must

    • (a) in the case of a verbal transfer, record the information required by subsection 51(3);

    • (b) in the case of a written transfer, have obtained from the transferring pharmacist a copy of

      • (i) the prescription written by the practitioner, or

      • (ii) the record made in accordance with subsection 51(3) of the practitioner’s verbal prescription; and

    • (c) in all cases, record

      • (i) the name and address of the transferring pharmacist,

      • (ii) the number of authorized refills remaining and, if applicable, the specified interval between refills, and

      • (iii) the date of the last refill.

  • Marginal note:Records — transferring pharmacist

    (3) A pharmacist who transfers a prescription under subsection (1) must record the date of the transfer, the name of the pharmacist to whom the prescription was transferred, the name and address of the pharmacy where that pharmacist practises and, if applicable, the number of refills that are being transferred.

  • SOR/2014-260, s. 35(F)

Marginal note:Activities without a prescription

  •  (1) A pharmacist may sell, provide, send, deliver or transport a targeted substance without a prescription to any of the following persons on receipt of an order from that person that specifies the name and quantity of the targeted substance:

    • (a) if the order is written, a licensed dealer who

      • (i) sold or provided the targeted substance, or

      • (ii) is licensed to destroy targeted substances, other than those that the licensed dealer produced, made, assembled, sold or provided;

    • (b) subject to subsection (2),

      • (i) a practitioner,

      • (ii) another pharmacist, if the other pharmacist states that the targeted substance is required because of a delay or shortfall in an order for the targeted substance placed with a licensed dealer, or

      • (iii) a hospital, if the order is placed by a pharmacist practising in the hospital or by a practitioner who is authorized to order the targeted substance on behalf of the hospital;

    • (c) the Minister, if the order is a written order signed on the Minister’s behalf; or

    • (d) a person to whom an exemption with respect to the targeted substance has been granted under section 56 of the Act, if the order is a written order and is accompanied by a copy of the exemption.

  • Marginal note:Verbal orders

    (2) In the circumstances set out in subparagraphs (1)(b)(i) to (iii), if the order is verbal, the pharmacist must record the following information:

    • (a) the name and address of the pharmacist or practitioner placing the order;

    • (b) if the order was placed on behalf of an establishment, the name and address of the establishment;

    • (c) the date of the order;

    • (d) the specified name or the brand name of the targeted substance ordered, as specified in the order;

    • (e) the quantity and, if applicable, the strength per unit of the targeted substance; and

    • (f) the name of the recording pharmacist.

  • Marginal note:Records

    (3) A pharmacist who sells, provides, sends, delivers or transports a targeted substance without a prescription must keep a record of the following information:

    • (a) the brand name of the targeted substance or, if the targeted substance does not have a brand name, the specified name;

    • (b) the quantity and strength per unit of the targeted substance;

    • (c) the name and address of the person referred to in subsection (1) to whom the targeted substance was sold, provided, sent, delivered or transported; and

    • (d) the date of the transaction.

  • Marginal note:Copies

    (4) The pharmacist must keep the written order or, if the order is verbal, must create a hard copy of the order.

  • SOR/2010-223, s. 25

General Obligations of Pharmacists

Marginal note:Change of location

 A pharmacist who closes premises in which a targeted substance has been stored must, not later than 10 days after the closure, inform the Minister of the date of closure, the location to which the targeted substance was moved and the quantity of the targeted substance that was moved.

Marginal note:Renunciation of privileges

  •  (1) A pharmacist who does not wish to receive or have possession of targeted substances may make a written request to the Minister to send to licensed dealers and pharmacies a notice, issued under section 79, that states that targeted substances must not be supplied to that pharmacist.

  • Marginal note:Prohibited actions

    (2) A pharmacist must not, unless their pharmacy has received a retraction issued under section 80,

    • (a) sell or provide a targeted substance to a pharmacist or practitioner named in a notice issued under section 79; or

    • (b) fill a prescription or order for a targeted substance from a practitioner named in a notice issued under section 79.

PART 3Practitioners

Marginal note:To patients only

 A practitioner may, with respect to a targeted substance, prescribe it for or administer it to an individual or animal, or sell, provide, send, deliver or transport it to or for an individual or for the benefit of an animal, only if

  • (a) the individual or animal is a patient that the practitioner is treating in their professional capacity; and

  • (b) the targeted substance is required to treat the individual’s or animal’s medical condition.

  • SOR/2010-223, s. 26(F)

Marginal note:Emergency supply

  •  (1) A practitioner of medicine may store an emergency supply of targeted substances at a remote location where emergency medical treatment is not readily available or in an emergency medical service vehicle, if the practitioner has an agent or mandatary at that location or in the vehicle who will control and administer the targeted substances on behalf of, and under the direction of, the practitioner.

  • Marginal note:Emergency use

    (2) When aid is being provided to an individual in an emergency, the agent or mandatary of the practitioner of medicine may administer a targeted substance from the emergency supply to the individual if

    • (a) the practitioner of medicine has, by telephone or other means, directed the agent or mandatary to administer the targeted substance; or

    • (b) the agent or mandatary follows written directives provided by the practitioner with respect to the administration of the targeted substance.

  • SOR/2010-223, s. 27
  • SOR/2018-69, s. 78(E)

Marginal note:Records — practitioner

  •  (1) A practitioner must keep the following records:

    • (a) the brand name or, if the targeted substance does not have a brand name, the specified name, the quantity and strength per unit of any targeted substance received from a licensed dealer, pharmacist or hospital and the date on which it is received;

    • (b) the name and address of the licensed dealer, pharmacist or hospital that sold or provided the targeted substance;

    • (c) if a transaction involves a quantity of targeted substance that exceeds five times the usual daily dose for the substance, the name and quantity of the substance prescribed, administered, sold, provided, sent, delivered or transported, the name and address of the recipient and the date of the transaction; and

    • (d) in the case of an emergency supply referred to in subsection 59(1), the name of the administering agent or mandatary, the location of the emergency supply, the name, quantity and strength per unit of each targeted substance, the date of all transactions related to that emergency supply and the name of any individual to whom the targeted substance was administered.

  • Marginal note:Records — agent or mandatary

    (2) In respect of the administration of a targeted substance from an emergency supply referred to in subsection 59(1), the agent or mandatary of the practitioner must keep the following records:

    • (a) the name, strength per unit and quantity of each targeted substance administered and the date on which it was administered;

    • (b) the name of the individual to whom the targeted substance was administered; and

    • (c) the name of the agent or mandatary of the practitioner who administered the targeted substance.

  • SOR/2010-223, s. 28
  • SOR/2018-69, s. 78(E)

Marginal note:Obligations — agents

  •  (1) An agent or mandatary of a practitioner of medicine referred to in subsection 59(1) must

    • (a) take reasonable steps to protect any targeted substance in their possession from loss and theft; and

    • (b) inform the practitioner without delay of any loss or theft of a targeted substance.

  • Marginal note:Obligations — practitioner of medicine

    (2) A practitioner of medicine who is informed by their agent or mandatary of loss or theft of a targeted substance must inform the Minister in accordance with section 7.

  • SOR/2018-69, s. 78(E)

Marginal note:Request for renunciation

 A practitioner who does not wish to receive or have possession of targeted substances may make a written request to the Minister to send to licensed dealers and pharmacies a notice issued under section 79 that states that

  • (a) recipients of the notice must not sell or provide any targeted substance to that practitioner; and

  • (b) pharmacists practising in the notified pharmacies must not fill a prescription or order for any targeted substance provided by that practitioner.

  • SOR/2010-223, s. 29(E)
  • SOR/2014-260, s. 36(F)

PART 4Hospitals

Marginal note:Authorization

  •  (1) A hospital may, in accordance with this Part, sell, provide, administer, send, deliver or transport a targeted substance.

  • Marginal note:Ordering targeted substances

    (2) No person may order a targeted substance on behalf of a hospital other than a pharmacist or practitioner practising in the hospital who is authorized by the person in charge of the hospital to order targeted substances for the hospital.

Marginal note:Provision or administration to a patient

 The person in charge of a hospital must not permit a targeted substance to be sold, provided or administered to a patient or animal under treatment as an in-patient or an out-patient of the hospital except pursuant to a prescription or other authorization of a practitioner practising in the hospital.

  • SOR/2014-260, s. 37(F)

Marginal note:Supply to non-patients

  •  (1) A pharmacist practising in a hospital or an individual who is authorized by the person in charge of a hospital to fill orders for targeted substances on behalf of the hospital may, on receipt of an order specifying the name, quantity and, if applicable, strength per unit of a targeted substance from any of the following persons, sell or provide the targeted substance to that person without a prescription:

    • (a) subject to subsection (2),

      • (i) a licensed dealer who

        • (A) sold or provided the substance, or

        • (B) is licensed to destroy targeted substances other than those that the licensed dealer produced, made, assembled, sold or provided,

      • (ii) a practitioner, if the practitioner states that the substance is required because of a delay or shortfall in an order for the substance placed with a licensed dealer or pharmacist,

      • (iii) a pharmacist, if the pharmacist states that the substance is required because of a delay or shortfall in an order for the substance placed with a licensed dealer, or

      • (iv) another hospital, if the order is placed by a pharmacist practising in the other hospital or a practitioner who is authorized to order the targeted substance on behalf of the other hospital and the order states that the substance is required because of a delay or shortfall in an order placed with a licensed dealer or a pharmacist;

    • (b) the Minister, if the order is a written order signed on the Minister’s behalf; and

    • (c) a person to whom an exemption with respect to the targeted substance has been granted under section 56 of the Act, if

      • (i) the person is an employee of or associated with the hospital, and

      • (ii) the order is a written order accompanied by a copy of the exemption.

  • Marginal note:Verbal orders

    (2) In the circumstances set out in paragraph (1)(a), if the order is verbal, the pharmacist practising in the hospital or the individual who is authorized by the person in charge of the hospital to fill orders for the targeted substance on behalf of the hospital must, before filling the order, record the following information:

    • (a) the date on which the order was received;

    • (b) the name and address of the person placing the order;

    • (c) the brand name of the targeted substance or, if the targeted substance does not have a brand name, the specified name;

    • (d) the quantity of the targeted substance ordered; and

    • (e) their name.

Marginal note:Information

 The person in charge of a hospital must record, or cause to be recorded, the following information:

  • (a) the brand name or, if the targeted substance does not have a brand name, the specified name, the quantity of any targeted substance received by the hospital and the date on which it was received;

  • (b) the name and address of the licensed dealer, pharmacist or other hospital that sold or provided the targeted substance;

  • (c) the name and quantity of the targeted substance sold, provided, administered, sent, delivered or transported, the name and address of the recipient and the date of the transaction; and

  • (d) the name and address of any out-patient to whom a targeted substance is sold or provided under section 64.

  • SOR/2010-223, s. 30

Marginal note:Closure

 If a targeted substance is stored in a hospital or the pharmacy department of a hospital and the hospital or department closes, the person in charge of the hospital must, not later than 10 days after the day of the closure, inform the Minister of the date of closure, the location to which the targeted substance was moved and the quantity of the targeted substance that was moved.

  • SOR/2010-223, s. 31(E)

PART 5Individuals

Marginal note:Importation — Canadian residents

  •  (1) An individual who is a resident of Canada may, at the time of the individual’s return to Canada from a foreign country, import a targeted substance that is in their possession at the time of entry if

    • (a) the substance has been obtained under a prescription and is labelled with the information set out in paragraphs 51(2)(a) to (g);

    • (b) the individual is importing the substance

      • (i) for their own use,

      • (ii) for the use of a person for whom the individual is responsible and who is travelling with them, or

      • (iii) for the use of an animal for which the individual is responsible and which is travelling with them;

    • (c) the substance is imported to meet the medical needs of the individual or animal for whose benefit it is prescribed;

    • (d) the substance is declared to a customs office at the port of entry into Canada at the time of import; and

    • (e) the quantity being imported does not exceed the lesser of

      • (i) a single course of treatment, and

      • (ii) a 90-day supply, based on the usual daily dose.

  • Marginal note:Importation — foreign residents

    (2) An individual who is a resident of a foreign country may, at the time that the individual enters Canada, import a targeted substance that is in their possession at the time of entry if

    • (a) the requirements set out in paragraphs (1)(a) to (d) are met; and

    • (b) the quantity imported is the least of

      • (i) the content of the container,

      • (ii) a 90-day supply, based on the usual daily dose, and

      • (iii) the usual daily dose multiplied by the number of days that the individual will stay in Canada.

Marginal note:Export

 An individual may, at the time of their departure from Canada, export a targeted substance that is in their possession at the time of departure if

  • (a) the substance has been obtained under a prescription and is labelled with the information set out in paragraphs 51(2)(a) to (g);

  • (b) the individual is exporting the substance

    • (i) for their own use,

    • (ii) for the use of a person for whom the individual is responsible and who is travelling with them, or

    • (iii) for the use of an animal for which the individual is responsible and which is travelling with them;

  • (c) the substance is required to meet the medical needs of the individual or animal for whose benefit it is prescribed; and

  • (d) the quantity exported does not exceed the lesser of

    • (i) a single course of treatment, and

    • (ii) a 90-day supply, based on the usual daily dose.

PART 6Test Kits

Marginal note:Authorization

  •  (1) A person may sell, provide, send, deliver, transport, import or export a test kit if

    • (a) a registration number has been issued for the test kit under subsections 72(1) or 75(2) and the number has not been cancelled under section 74;

    • (b) the test kit is labelled with

      • (i) the registration number, and

      • (ii) in the case of a test kit that is not subject to the labelling requirements of the Medical Devices Regulations,

        • (A) the name and address of the maker or assembler or, in the case where the test kit is made or assembled pursuant to a custom order, the name and address of the person for whom the test kit was custom made or assembled, and

        • (B) its brand name; and

    • (c) the test kit is sold, provided, sent, delivered, transported, imported or exported for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose.

  • Marginal note:Individual

    (2) An individual who does not hold a dealer’s licence may possess a test kit that contains a targeted substance set out in Part 2 of Schedule 1 if the test kit is labelled with its registration number.

  • SOR/2010-223, s. 32

Marginal note:Application for a registration number

  •  (1) The manufacturer or assembler of a test kit or, if the test kit is manufactured or assembled pursuant to a custom order, the person for whom the test kit was manufactured or assembled, may apply for a registration number for the test kit by submitting to the Minister an application containing

    • (a) the brand name of the test kit;

    • (b) particulars of the design and construction of the test kit;

    • (b.1) a statement of the proposed use of the test kit;

    • (c) a detailed description of the targeted substance contained in the test kit, including

      • (i) the specified name for the substance,

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

      • (iii) the quantity of the substance;

    • (d) a detailed description of each other substance contained in the test kit, including

      • (i) the name of each substance,

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

      • (iii) the quantity of each substance; and

    • (e) the directions for use of the test kit.

  • Marginal note:Statement by signatory

    (2) An application for the registration of a test kit must

    • (a) be signed by an individual authorized by the applicant for that purpose; and

    • (b) indicate that all the information submitted in support of the application is correct and complete to the best of the signatory’s knowledge.

  • SOR/2010-223, ss. 33, 42(E)

Marginal note:Issuance of a registration number

  •  (1) Subject to subsection (2), the Minister must, after examining the information and documents required under sections 11 and 71, issue a registration number for the test kit to the applicant if the applicant demonstrates that the test kit is designed to be used solely for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose.

  • Marginal note:Refusal

    (2) The Minister must refuse to issue a registration number if the Minister has reasonable grounds to believe that

    • (a) the test kit poses a risk to security, public health or safety, including the risk of the targeted substance in the test kit being diverted to an illicit market or use, because

      • (i) the total amount of the targeted substance in the test kit is too high, or

      • (ii) the adulterating or denaturing agent in the test kit is not likely to prevent or deter consumption of the targeted substance in the test kit by a human or animal or the administration of that substance to a human or animal; or

    • (b) the test kit is likely to be used for a purpose other than those set out in subsection (1).

  • SOR/2010-223, ss. 34, 43(F)

Marginal note:Effect of the registration number

 The requirement in subparagraph C.01.004(1)(b)(iv) of the Food and Drug Regulations that a symbol be displayed on the label of a targeted substance does not apply to a test kit if a registration number has been issued under subsection 72(1) or 75(2) for that test kit and the number is displayed on the label.

  • SOR/2010-223, s. 35(E)

Marginal note:Cancellation

  •  (1) The Minister must cancel the registration number of a test kit if

    • (a) the Minister receives a notice from the holder of the registration number stating that it has ceased all activities referred to in section 70 with respect to the test kit;

    • (b) the test kit is a medical device and is no longer approved for sale in Canada under the Medical Devices Regulations; or

    • (c) there exists a reason set out in paragraph 72(2)(a).

  • Marginal note:Non-compulsory compensation

    (2) The Minister may cancel the registration number of a test kit if the Minister determines that the test kit is being used for a purpose other than a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose and, after considering the nature and extent of that other purpose, concludes that it poses a risk to security, public health or safety, including the risk of the targeted substance in the test kit being diverted to an illicit market or use.

  • Marginal note:Effect of cancellation

    (3) When a registration number issued for a test kit is cancelled, the cancelled registration number

    • (a) must not be displayed on the label of any test kit made or assembled after the cancellation; and

    • (b) in the case of a cancellation under paragraph (1)(a), must remain on the label of any existing test kit until all of the test kits with that registration number are disposed of.

  • SOR/2010-223, s. 36

Marginal note:Application for a new number

  •  (1) If a registration number issued for a test kit has been cancelled under subsection 74(1) or (2), the maker or assembler of the test kit or, where the test kit is made or assembled pursuant to a custom order, the person for whom the test kit was custom made or assembled

    • (a) may, after a period of 90 days following the cancellation, apply to the Minister for the issuance of a new registration number; and

    • (b) must, in support of the application, provide the Minister with proof that the circumstance that gave rise to the cancellation has been corrected.

  • Marginal note:New number

    (2) The Minister, after examining the application and supporting proof referred to in subsection (1), must issue a new registration number for the test kit unless there exists a circumstance set out in paragraph 74(1)(b) or (c) or subsection 74(2).

Marginal note:Notice to the Minister

 The holder of a registration number for a test kit issued under subsection 72(1) or 75(2) must inform the Minister in writing, within 30 days after the event, if they have

  • (a) ceased all activities referred to in section 70 with respect to the test kit;

  • (b) transferred the making or assembly of the test kit to another person;

  • (c) increased the quantity of targeted substance in the test kit;

  • (d) changed the brand name of the test kit;

  • (e) altered in any manner the adulterating or denaturing agent in the test kit or changed the quantity of either agent in it; or

  • (f) substituted a new adulterating or denaturing agent.

PART 7Targeted Substances in Transit or Transhipment

Marginal note:Application

  •  (1) If a targeted substance is being 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 an agent or mandatary in Canada of that exporter must apply to the Minister for a permit for transit or transhipment by providing the following information:

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

    • (b) the name, 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 for which the permit is requested,

      • (i) its specified name,

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

      • (iii) if applicable, its brand name,

      • (iv) the quantity,

      • (v) in the case of a raw material, its purity, and

      • (vi) if applicable, its anhydrous content;

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

    • (e) the name of the Canadian port of entry and exit;

    • (f) each mode of transportation that is to be used in Canada for the targeted substance; and

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

  • Marginal note:Supporting documentation

    (2) An application referred to in subsection (1) must be accompanied by

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

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

  • Marginal note:Statement by signatory

    (3) An application referred to in subsection (1) must

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

    • (b) state that all the information submitted in support of the application is correct and complete to the best of the signatory’s knowledge.

  • SOR/2010-223, ss. 37(E), 42(E)
  • SOR/2018-69, s. 78(E)

Marginal note:Permit for transit or transhipment

  •  (1) Subject to subsection (2), after examining the information and documents required under sections 11 and 77, the Minister must issue a permit for transit or transhipment that contains the following information:

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

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

    • (c) the specified name, quantity, purity and strength per unit of the targeted substance;

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

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

    • (f) the names of the Canadian ports of entry and exit;

    • (g) each mode of transportation that is to be used for the targeted substance while in Canada;

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

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

  • Marginal note:Refusal to issue a permit

    (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 not be in conformity with an international obligation,

      • (ii) would be in contravention of the Act, the regulations, 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 security, 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 a competent authority in the country of final destination has expired or has been suspended or revoked.

  • SOR/2010-223, ss. 38(E), 43(F)

PART 8Minister

Marginal note:Notice to cease providing targeted substances

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

    • (a) licensed dealers and pharmacists practising in the notified pharmacies 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 a prescription or order for any targeted substance provided by the practitioner named in the notice; or

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

  • Marginal note:Circumstances

    (2) The notice must be issued 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, as the case may be, to issue the notice;

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

    • (c) been found guilty in a court of law of a designated drug offence or of an offence under these Regulations.

  • Marginal note:Recipients

    (3) The notice must be issued to

    • (a) all licensed dealers;

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

    • (d) any provincial professional licensing authority in another province that has made a request to the Minister to issue the notice; and

    • (e) any pharmacies in an adjacent province in which a prescription or order from the pharmacist or practitioner named in the notice may be filled.

  • Marginal note:Other circumstances

    (4) Subject to subsection (5), the Minister may issue the notice described in subsection (1) to the persons and authorities specified in subsection (3), if the Minister, on reasonable grounds, believes that the pharmacist or practitioner named in the notice

    • (a) has contravened a provision of the Act or the 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 pharmaceutical, medical, dental or veterinary 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 pharmaceutical, medical, dental or veterinary 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 issuance

    (5) In the circumstances described in subsection (4), the Minister must not issue the notice referred to in subsection (1) until 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 authorized or entitled to practise;

    • (b) given that pharmacist or practitioner an opportunity to present reasons why the notice should not be issued; and

    • (c) considered

      • (i) the compliance history of the pharmacist or practitioner in respect of the Act and the regulations made or continued under it, and

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

  • SOR/2010-223, ss. 39, 43(F)
  • SOR/2014-260, s. 38

Marginal note:Retraction

 The Minister must provide the licensed dealers, pharmacies and provincial professional licensing authorities who were sent a notice under subsection 79(1) with a 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 issued, and

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

  • SOR/2010-223, s. 40

Marginal note:Provision of information

 The Minister may provide in writing any factual information about a pharmacist, a practitioner or a nurse that has been obtained under the Act or these Regulations to the provincial professional licensing authority responsible for the authorization or entitlement of the person to practise their profession

  • (a) in the province in which the pharmacist, practitioner or nurse is authorized or entitled to practise if

    • (i) the authority submits a written request that sets out the name and address of the pharmacist, practitioner or nurse, a description of the information being sought 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 pharmacist, practitioner or nurse has

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

      • (B) been found guilty in a court of law of a designated drug offence or of a contravention of these Regulations, or

      • (C) in the case of a pharmacist or practitioner, done any act that the Minister, on reasonable grounds, believes contravenes a provision of these Regulations; or

  • (b) in a province in which the pharmacist, practitioner or nurse is not authorized or entitled to practise, if the authority submits to the Minister

    • (i) a written request for information that states

      • (A) the name and address of the pharmacist, practitioner or nurse, and

      • (B) a description of the information being sought, and

    • (ii) documentation that shows that the pharmacist, practitioner or nurse has applied to that authority to practise in that province.

  • SOR/2010-223, s. 41

PART 9Coming into Force

Marginal note:Coming into force

  •  (1) Subject to subsection (2), these Regulations come into force on September 1, 2000.

  • Marginal note:Exception

    (2) Subparagraph 3(b)(ii), paragraphs 20(1)(h) and 21(f), subparagraph 21(i)(ii), paragraph 22(f), subparagraphs 25(3)(b)(ii) and 26(1)(a)(i) and section 73 come into force on September 1, 2001.

SCHEDULE 1(Subsection 1(1), section 4 and subsections 15(1), 20(1) and 70(2))

PART 1

List of Class 1 Targeted Substances

ItemName
1
  • Benzodiazepines, their salts and derivatives, including
    • (1) 
      Alprazolam (8-chloro-1-methyl-6-phenyl-4H — s-triazolo[4,3-a][1,4]benzodiazepine)
    • (2) 
      Bromazepam (7-bromo-1,3-dihydro-5-(2-pyridyl) — 2H-1,4-benzodiazepin-2-one)
    • (3) 
      Brotizolam (2-bromo-4-(o-chlorophenyl)-9-methyl-6H-thieno[3,2-f]-s-triazolo[4,3-a][1,4]diazepine)
    • (4) 
      Camazepam (7-chloro-1,3-dihydro-3-(N,N-dimethylcarbamoyl) — 1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one)
    • (5) 
      Chlordiazepoxide (7-chloro-2-(methylamino)-5 — phenyl-3H-1,4-benzodiazepine-4-oxide)
    • (6) 
      Clobazam (7-chloro-1-methyl-5-phenyl-1H-1,5 — benzodiazepine-2,4(3H,5H)-dione)
    • (7) 
      Clonazepam (5-(o-chlorophenyl)-1,3-dihydro-7 — nitro-2H-1,4-benzodiazepin-2-one)
    • (8) 
      Clorazepate (7-chloro-2,3-dihydro-2,2-dihydroxy — 5-phenyl-1H-1, 4-benzodiazepine-3-carboxylic acid)
    • (9) 
      Cloxazolam (10-chloro-11b-(o-chlorophenyl)-2,-3,7,11b-tetrahydrooxazolo [3,2-d][1,4]benzodiazepin-6[5H]-one)
    • Delorazepam (7-chloro-5-(o-chlorophenyl)-1,3-dihydro-2H-1,-4-benzodiazepin-2-one)
    • Diazepam (7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one)
    • Estazolam (8-chloro-6-phenyl-4H-s-triazolo[4,3-a] — [1,4]benzodiazepine)
    • Ethyl Loflazepate (ethyl 7-chloro-5-(o-fluorophenyl)-2,3-dihydro-2-oxo-1H-1,-4-benzodiazepine-3-carboxylate)
    • Fludiazepam (7-chloro-5-(o-fluorophenyl)-1,3-dihydro-1-methyl-2H-1,4-benzodiazepin-2-one)
    • Flurazepam (7-chloro-1-[2-(diethylamino)ethyl]-5-(o-fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one)
    • Halazepam (7-chloro-1,3-dihydro-5-phenyl-1-(2,2,-2-trifluoroethyl)-2H-1,4-benzodiazepin-2-one)
    • Haloxazolam (10-bromo-11b-(o-fluorophenyl)-2,3,7,11b-tetrahydro-oxazolo[3,2-d][1,4]benzodiazepin-6(5H)-one)
    • Ketazolam (11-chloro-8,12b-dihydro-2,8-dimethyl-12b-phenyl-4H-[1,3]-oxazino-[3,2-d][1,4]benzodiazepine-4,7(6H)-dione)
    • Loprazolam (6-(o-chlorophenyl)-2,4-dihydro-2-[(4--methyl-1-piperazinyl)methylene]-8-nitro-1H-imidazo[1,2-a] [1,4]-benzodiazepin-1-one)
    • Lorazepam (7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one)
    • Lormetazepam (7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-1-methyl-2H-1,4-benzodiazepin-2-one)
    • Medazepam (7-chloro-2,3-dihydro-1-methyl-5-phenyl-1H-1,4-benzodiazepine)
    • Midazolam (8-chloro-6-(o-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine)
    • Nimetazepam (1,3-dihydro-1-methyl-7-nitro-5-phenyl-2H-1,4-benzodiazepin-2-one)
    • Nitrazepam (1,3-dihydro-7-nitro-5-phenyl-2H-1,4-benzodiazepin-2-one)
    • Nordazepam (7-chloro-1,3-dihydro-5-phenyl — 2H-1,4-benzodiazepin-2-one)
    • Oxazepam (7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one)
    • Oxazolam (10-chloro-2,3,7,11b-tetrahydro-2-methyl-11b-phenyloxazolo[3,2-d][1,4]benzodiazepin-6(5H)-one)
    • Pinazepam (7-chloro-1,3-dihydro-5-phenyl-1-(2-propynyl)-2H-1,-4-benzodiazepin-2-one)
    • Prazepam (7-chloro-1-(cyclopropylmethyl)-1,3-di-hydro-5-phenyl-2H-1,4-benzodiazepin-2-one)
    • Quazepam (7-chloro-5-(o-fluorophenyl)-1,3-dihydro-1-(2,2,2-trifluoroethyl)-2H-1,4-benzodiazepine-2-thione)
    • Temazepam (7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one)
    • Tetrazepam (7-chloro-5-(cyclohexen-1-yl)-1,3-di-hydro-1-methyl-2H-1,4-benzodiazepin-2-one)
    • Triazolam (8-chloro-6-(o-chlorophenyl)-1-methyl-4H-s-triazolo-[4,3-a][1,4]benzodiazepine)
    • but not including
    • Clozapine (8-chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine) and any salt thereof
    • Flunitrazepam (5-(o-fluorophenyl)-1,3-dihydro-1-methyl-7-nitro-2H-1,4-benzodiazepin-2-one) and any salts or derivatives thereof
    • Olanzapine (2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine) and its salts
    • Clozapine N-oxide (8-chloro-11-(4-methyl-4-oxido-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine) and its salts
2Clotiazepam (5-(o-chlorophenyl)-7-ethyl-1,3-dihydro-1-methyl-2-H-thieno[2,3-e]-1,4-diazepin-2-one) and any salt thereof
3Ethchlorvynol (ethyl-2-chlorovinyl ethynyl carbinol)
4Ethinamate (1-ethynylcyclohexanol carbamate)
5Fencamfamin (d,l-N-ethyl-3-phenylbicyclo[2,2,1]-heptan-2-amine) and any salt thereof
6Fenproporex (d,l-3-[(α-methylphenethyl)amino]propionitrile) and any salt thereof
7Mazindol (5-(p-chlorophenyl)-2,5-dihydro-3H-imidazo[2,1-a]isoindol-5-ol)
8Mefenorex (d,l-N-(3-chloropropyl)-α-methylbenzene-ethanamine) and any salt thereof
9Meprobamate (2-methyl-2-propyl-1,3-propanedioldicarbamate)
10Methyprylon (3,3-diethyl-5-methyl-2,4-piperidinedione)
11Pipradrol (α,α-diphenyl-2-piperidinemethanol) and any salt thereof
12Zolpidem (N,N,6-trimethyl-2-(4-methylphenyl)imidazo[1,2-a]pyridine-3-acetamide) and any salt thereof

PART 2

List of Class 2 Targeted Substances

ItemName
1Flunitrazepam (5-(o-fluorophenyl)-1,3-dihydro-1-methyl-7-nitro-2H-1,4-benzodiazepin-2-one) and any salts or derivatives thereof
  • SOR/2003-38, s. 3
  • SOR/2017-12, ss. 10, 11

SCHEDULE 2(Subsection 1(1))

Specified Names of Targeted Substances

ItemColumn 1Column 2
Specified NameChemical Name
1Alprazolam8-chloro-1-methyl-6-phenyl-4H — s-triazolo[4,3-a][1,4]benzodiazepine
2Bromazepam7-bromo-1,3-dihydro-5-(2-pyridyl) — 2H-1,4-benzodiazepin-2-one
3Brotizolam2-bromo-4-(o-chlorophenyl)-9-methyl-6H-thieno[3,2-f]-s-triazolo[4,3-a][1,4]diazepine
4Camazepam7-chloro-1,3-dihydro-3-(N,N-dimethylcarbamoyl) — 1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one
5Chlordiazepoxide7-chloro-2-(methylamino)-5 — phenyl-3H-1,4-benzodiazepine-4-oxide
6Clobazam7-chloro-1-methyl-5-phenyl-1H-1,5 — benzodiazepine-2,4(3H,5H)-dione
7Clonazepam5-(o-chlorophenyl)-1,3-dihydro-7 — nitro-2H-1,4-benzodiazepin-2-one
8Clorazepate7-chloro-2,3-dihydro-2,2-dihydroxy-5-phenyl-1H-1,4-benzodiazepine-3-carboxylic acid
9Cloxazolam10-chloro-11b-(o-chlorophenyl)-2,-3,7,11b-tetrahydrooxazolo[3,2-d][1,4]benzodiazepin-6[5H]-one
10Delorazepam7-chloro-5-(o-chlorophenyl)-1,3-dihydro-2H-1,-4-benzodiazepin-2-one
11Diazepam7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one
12Estazolam8-chloro-6-phenyl-4H-s-triazolo[4,3-a] — [1,4]benzodiazepine
13Ethyl Loflazepateethyl 7-chloro-5-(o-fluorophenyl)-2,3-dihydro-2-oxo-1H-1,-4-benzodiazepine-3-carboxylate
14Fludiazepam7-chloro-5-(o-fluorophenyl)-1,3-di-hydro-1-methyl-2H-1,4-benzodiazepin-2-one
15Flurazepam7-chloro-1-[2-(diethylamino)ethyl]-5-(o-fluorophenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one
16Halazepam7-chloro-1,3-dihydro-5-phenyl-1-(2,2,-2-trifluoroethyl)-2H-1,4-benzodiazepin-2-one
17Haloxazolam10-bromo-11b-(o-fluorophenyl)-2,3,7,11b-tetrahydro-oxazolo[3,2-d][1,4]benzodiazepin-6(5H)-one
18Ketazolam11-chloro-8,12b-dihydro-2,8-dimethyl-12b-phenyl-4H-[1,3]-oxazino-[3,2-d][1,4]benzodiazepine-4,7(6H)-dione
19Loprazolam6-(o-chlorophenyl)-2,4-dihydro-2-[(4--methyl-1-piperazinyl)methylene]-8-nitro-1H-imidazo[1,2-a][1,4]-benzodiazepin-1-one
20Lorazepam7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one
21Lormetazepam7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-1-methyl-2H-1,4-benzodiazepin-2-one
22Medazepam7-chloro-2,3-dihydro-1-methyl-5-phenyl-1H-1,4-benzodiazepine
23Midazolam8-chloro-6-(o-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine
24Nimetazepam1,3-dihydro-1-methyl-7-nitro-5-phenyl-2H-1,4-benzodiazepin-2-one
25Nitrazepam1,3-dihydro-7-nitro-5-phenyl-2H-1,4-benzodiazepin-2-one
26Nordazepam7-chloro-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one
27Oxazepam7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one
28Oxazolam10-chloro-2,3,7,11b-tetrahydro-2-methyl-11b-phenyloxazolo[3,2-d][1,4]benzodiazepin-6(5H)-one
29Pinazepam7-chloro-1,3-dihydro-5-phenyl-1-(2-propynyl)-2H-1,-4-benzodiazepin-2-one
30Prazepam7-chloro-1-(cyclopropylmethyl)-1,3-di-hydro-5-phenyl-2H-1,4-benzodiazepin-2-one
31Quazepam7-chloro-5-(o-fluorophenyl)-1,3-dihydro-1-(2,2,2-trifluoroethyl)-2H-1,4-benzodiazepine-2-thione
32Temazepam7-chloro-1,3-dihydro-3-hydroxy-1methyl-5-phenyl-2H-1,4-benzodiazepin-2-one
33Tetrazepam7-chloro-5-(cyclohexen-1-yl)-1,3-di-hydro-1-methyl-2H-1,4-benzodiazepin-2-one
34Triazolam8-chloro-6-(o-chlorophenyl)-1-methyl-4H-s-triazolo-[4,3-a][1,4]benzodiazepine
35Clotiazepam5-(o-chlorophenyl)-7-ethyl-1,3-dihydro-1-methyl-2-H-thieno[2,3-e]-1,4-diazepin-2-one
36Ethchlorvynolethyl-2-chlorovinyl ethynyl carbinol
37Ethinamate1-ethynylcyclohexanol carbamate
38Fencamfamind,l-N-ethyl-3-phenylbicyclo[2,2,1]-heptan-2-amine
39Fenproporexd,l-3-[(α-methylphenethyl)amino]propionitrile
40Flunitrazepam3(5-(o-fluorophenyl)-1,3-dihydro-1-methyl-7-nitro-2H-1,4-benzodiazepin-2-one
41Mazindol5-(p-chlorophenyl)-2,5-dihydro-3H-imidazo[2,1-a]isoindol-5-ol
42Mefenorexd,l-N-(3-chloropropyl)-α-methylbenzene-ethanamine
43Meprobamate2-methyl-2-propyl-1,3-propanedioldicarbamate
44Methyprylon3,3-diethyl-5-methyl-2,4-piperidinedione
45Pipradrolα,α-diphenyl-2-piperidinemethanol
46ZolpidemN,N,6-trimethyl-2-(4-methylphenyl)imidazo[1,2-a]pyridine-3-acetamide
  • SOR/2003-38, s. 4
  • SOR/2017-12, s. 11

AMENDMENTS NOT IN FORCE

  • — SOR/2019-170, s. 1

      • 1 (1) The portion of subsection 1(1) of the English version of the Benzodiazepines and Other Targeted Substances RegulationsFootnote 1 before the definition Act is replaced by the following:

          • 1 (1) The following definitions apply in these Regulations.

      • (2) The definitions Department, designated drug offence, export permit, import permit, package and transhipment in subsection 1(1) of the Regulations are repealed.

      • (3) The definition personne qualifiée responsable in subsection 1(1) of the French version of the Regulations is repealed.

      • (4) The definitions licensed dealer, pharmacist, prescription, targeted substance and test kit in subsection 1(1) of the Regulations are replaced by the following:

        licensed dealer

        licensed dealer means the holder of a licence issued under section 17.1. (distributeur autorisé)

        pharmacist

        pharmacist means a person who is entitled under the laws of a province to practise pharmacy and is practising pharmacy in that province. (pharmacien)

        prescription

        prescription means an authorization given by a practitioner that a stated amount of a targeted substance be dispensed for the person named in it or the animal identified in it. (ordonnance)

        targeted substance

        targeted substance means

        • (a) a controlled substance set out in Schedule 1; or

        • (b) in respect of a midwife, nurse practitioner or podiatrist, a controlled substance set out in Schedule 1 that the midwife, nurse practitioner or podiatrist may prescribe, possess or conduct an activity with, in accordance with section 3 of the New Classes of Practitioners Regulations. (substance ciblée)

        test kit

        test kit means a kit

        • (a) that contains a targeted substance and a reagent system or buffering agent;

        • (b) that is used during the course of a chemical or analytical procedure to test for the presence or quantity of a targeted substance for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; and

        • (c) the contents of which are not intended or likely to be consumed by, or administered to, a person or an animal. (nécessaire d’essai)

      • (5) The definition qualified person in charge in subsection 1(1) of the English version of the Regulations is replaced by the following:

        qualified person in charge

        qualified person in charge means the individual designated under subsection 15(1). (responsable qualifié)

      • (6) The definition hôpital in subsection 1(1) of the French version of the Regulations is replaced by the following:

        hôpital L’établissement, selon le cas :

        • a) qui peut, en sa qualité d’hôpital, au titre d’une licence, d’une autorisation ou d’une désignation délivrée par une province sous le régime de ses lois, fournir des soins de santé ou des traitements aux personnes ou aux animaux;

        • b) qui fournit des services de santé et qui soit appartient au gouvernement du Canada ou au gouvernement d’une province, soit est exploité par lui. (hospital)

      • (7) Subsection 1(1) of the Regulations is amended by adding the following in alphabetical order:

        competent authority

        competent authority means a public authority of a foreign country that is authorized under the laws of the country to approve the importation or exportation of targeted substances into or from the country. (autorité compétente)

        designated criminal offence

        designated criminal offence means

        • (a) an offence involving the financing of terrorism against any of sections 83.02 to 83.04 of the Criminal Code;

        • (b) an offence involving fraud against any of sections 380 to 382 of the Criminal Code;

        • (c) the offence of laundering proceeds of crime against section 462.31 of the Criminal Code;

        • (d) an offence involving a criminal organization against any of sections 467.11 to 467.13 of the Criminal Code; or

        • (e) a conspiracy or an attempt to commit, being an accessory after the fact in relation to, or any counselling in relation to, an offence referred to in any of paragraphs (a) to (d). (infraction désignée en matière criminelle)

        destroy

        destroy, in respect of a targeted substance, means to alter or denature it to such an extent that its consumption is rendered impossible or improbable. (destruction)

        senior person in charge

        senior person in charge means the individual designated under section 14. (responsable principal)

      • (8) Subsection 1(1) of the French version of the Regulations is amended by adding the following in alphabetical order:

        qualified person in charge

        responsable qualifié L’individu désigné en vertu du paragraphe 15(1). (qualified person in charge)

      • (9) Subsection 1(1) of the Regulations is renumbered as section 1 and subsection 1(2) of the Regulations is repealed.

  • — SOR/2019-170, s. 2

    • 2 The heading before section 2 and sections 2 to 47 of the Regulations are replaced by the following:

      Non-application

      • Member of police force

        2 A member of a police force or a person acting under their direction and control who, in respect of the conduct of the member or person, is exempt from the application of subsection 4(2) or section 5, 6 or 7 of the Act by virtue of the Controlled Drugs and Substances Act (Police Enforcement) Regulations is, in respect of that conduct, exempt from the application of these Regulations.

      Possession

      • Authorized persons
        • 3 (1) A person is authorized to possess a targeted substance set out in Part 2 of Schedule 1 if the person has obtained the targeted substance in accordance with these Regulations, in the course of activities conducted in connection with the administration or enforcement of an Act or regulation, or from a person who is exempt under section 56 of the Act from the application of subsection 5(1) of the Act with respect to that targeted substance, and the person

          • (a) requires the targeted substance for their business or profession and is

            • (i) a licensed dealer,

            • (ii) a pharmacist, or

            • (iii) a practitioner who is registered and entitled to practise in the province in which they possess the targeted substance;

          • (b) is a practitioner who is registered and entitled to practise in a province other than the province in which they possess the targeted substance for emergency medical purposes only;

          • (c) is a hospital employee or a practitioner in a hospital;

          • (d) has obtained the targeted substance for their own use or the use of another person for whom, or an animal for which, they are responsible

            • (i) from a practitioner, or

            • (ii) in accordance with a prescription that was not issued or obtained in contravention of these Regulations;

          • (e) is employed as an inspector, a member of the Royal Canadian Mounted Police, a police constable, a peace officer or a member of the technical or scientific staff of the Government of Canada, the government of a province or a university in Canada and their possession is in connection with that employment;

          • (f) is exempt under section 56 of the Act with respect to the possession of that targeted substance and their possession is for a purpose set out in the exemption;

          • (g) has imported the targeted substance in accordance with section 68 for their own use or the use of another person for whom, or an animal for which, they are responsible;

          • (h) is a person who, in accordance with a permit for transit or transhipment, is responsible for the targeted substance while it is in transit or in transhipment in Canada; or

          • (i) is the Minister.

        • Agent or mandatary

          (2) A person is authorized to possess a targeted substance set out in Part 2 of Schedule 1 if the person is acting as the agent or mandatary of any person who is authorized to possess it in accordance with any of paragraphs (1)(a) to (d) and (f) to (h).

        • Agent or mandatary — person referred to in paragraph (1)(e)

          (3) A person is authorized to possess a targeted substance set out in Part 2 of Schedule 1 if they

          • (a) are acting as the agent or mandatary of a person who they have reasonable grounds to believe is a person referred to in paragraph (1)(e); and

          • (b) possess the targeted substance for the purpose of assisting that person in the administration or enforcement of an Act or regulation.

        • Export by individual

          (4) An individual may possess a targeted substance set out in Part 2 of Schedule 1 for the purpose of exporting that substance in accordance with section 69.

      Test Kits

      • Authorized activities

        4 A person may sell, possess or otherwise deal in a test kit if the following conditions are met:

        • (a) a registration number has been issued for the test kit under section 6 or subsection 10(2) and has not been cancelled under subsection 9(1);

        • (b) the test kit is labelled with

          • (i) the registration number, and

          • (ii) in the case of a test kit that is not subject to the labelling requirements of the Medical Devices Regulations,

            • (A) the name and address of the manufacturer or assembler or, if the test kit is manufactured or assembled in accordance with a custom order, the name and address of the person for whom the test kit was manufactured or assembled, and

            • (B) its brand name; and

        • (c) the test kit will be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose.

      • Application for registration number
        • 5 (1) The manufacturer or assembler of a test kit or, if the test kit is manufactured or assembled in accordance with a custom order, the person for whom the test kit was manufactured or assembled, may obtain a registration number for the test kit by submitting to the Minister an application containing

          • (a) the brand name of the test kit;

          • (b) a detailed description of the design and construction of the test kit;

          • (c) a detailed description of the targeted substance and other substances, if any, contained in the test kit, including

            • (i) the specified name of the targeted substance and the name of any other substance,

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

            • (iii) the quantity of the substance;

          • (d) a description of the proposed use of the test kit; and

          • (e) the directions for use of the test kit.

        • Signature and attestation

          (2) The application must

          • (a) be signed and dated by the person authorized by the applicant for that purpose; 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.

        • Additional information and documents

          (3) 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.

      • Issuance of registration number

        6 Subject to section 7, on completion of the review of the application for a registration number, the Minister must issue a registration number for the test kit, preceded by the letters “TK”, if the Minister determines that the test kit will only be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose.

      • Refusal of registration number
        • 7 (1) The Minister must refuse to issue a registration number for a test kit if the Minister has reasonable grounds to believe that

          • (a) the test kit poses a risk to public health or safety, including the risk of the targeted substance in the test kit being diverted to an illicit market or use, because

            • (i) the total amount of the targeted substance in the test kit is too high, or

            • (ii) the adulterating or denaturing agent in the test kit is not likely to prevent or deter the consumption of the targeted substance in the test kit by a person or animal or the administration of that substance to a person or animal; or

          • (b) the test kit is likely to be used for a purpose other than one referred to in section 6.

        • Notice

          (2) Before refusing to issue a registration number, the Minister must send the applicant a notice that sets out the Minister’s reasons and gives the applicant an opportunity to be heard.

      • Labelling — non-application

        8 The symbol required by subparagraph C.01.004(1)(b)(iv) of the Food and Drug Regulations does not need to appear on the label of a test kit if the label displays the registration number that has been issued for the test kit under section 6 or subsection 10(2).

      • Cancellation of registration number
        • 9 (1) The Minister must cancel the registration number of a test kit if

          • (a) the Minister receives a notice from the holder of the registration number stating that they have ceased to conduct all activities with respect to the test kit;

          • (b) the test kit is a medical device and is no longer approved for sale in Canada under the Medical Devices Regulations;

          • (c) one of the circumstances referred to in subparagraph 7(1)(a)(i) or (ii) exists; or

          • (d) the Minister has reasonable grounds to believe that the test kit is being used for a purpose other than a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose and that the test kit poses a risk to public health or safety, including the risk of the targeted substance in the test kit being diverted to an illicit market or use.

        • Effect of cancellation

          (2) When the registration number of a test kit is cancelled, the number

          • (a) must not be displayed on the label of any test kit manufactured or assembled after the cancellation; and

          • (b) in the case of a cancellation under paragraph (1)(a), must remain on the label of any existing test kit until all of the test kits with that registration number are disposed of.

      • Application for new number
        • 10 (1) The following persons may, after a period of 90 days following the cancellation of the registration number of a test kit, obtain a new registration number by submitting to the Minister an application that is supported by proof that the circumstances that gave rise to the cancellation have been corrected:

          • (a) the manufacturer or assembler of the test kit; or

          • (b) if the test kit is manufactured or assembled in accordance with a custom order, the person for whom the test kit was manufactured or assembled.

        • New number

          (2) On completion of the review of the application, the Minister must issue a new registration number for the test kit unless a condition referred to in any of paragraphs 9(1)(b) to (d) applies.

      • Notice to Minister

        11 The holder of a registration number for a test kit must inform the Minister in writing, within 30 days after the occurrence, if they have

        • (a) ceased to conduct all activities authorized by section 4 with respect to the test kit;

        • (b) transferred the manufacturing or assembly of the test kit to another person;

        • (c) increased the quantity of targeted substance in the test kit;

        • (d) changed the brand name of the test kit;

        • (e) altered in any manner the adulterating or denaturing agent in the test kit or changed the quantity of either agent in it; or

        • (f) substituted the adulterating or denaturing agent with another one.

      Licensed Dealers

      Authorized Activities

      • General
        • 12 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a targeted substance if they comply with these Regulations and the terms and conditions of their dealer’s licence and any permit issued under these Regulations.

        • Qualified person in charge present

          (2) A licensed dealer may conduct an activity in relation to a targeted substance at their site only if the qualified person in charge or an alternate qualified person in charge is present at the site.

        • Permit — import and export

          (3) A licensed dealer must obtain a permit in order to import or export a targeted substance.

        • Possession for export

          (4) A licensed dealer may possess a targeted substance for the purpose of exporting it if they have obtained it in accordance with these Regulations.

      Dealer’s Licences

      Preliminary Requirements
      • Eligible persons

        13 The following persons may apply for a dealer’s licence:

        • (a) an individual who ordinarily resides in Canada;

        • (b) a corporation that has its head office in Canada or operates a branch office in Canada; or

        • (c) the holder of a position that includes responsibility for targeted substances on behalf of the Government of Canada or of a government of a province, a police force, a hospital or a university in Canada.

      • Senior person in charge

        14 An applicant for a dealer’s licence must designate only one individual as the senior person in charge, who has overall responsibility for management of the activities with respect to targeted substances that are specified in the licence application. The applicant may designate themself if the applicant is an individual.

      • Qualified person in charge
        • 15 (1) An applicant for a dealer’s licence must designate only one individual as the qualified person in charge, who is responsible for supervising the activities with respect to targeted substances that are specified in the licence application and for ensuring that those activities comply with these Regulations. The applicant may designate themself if the applicant is an individual.

        • Alternate qualified person in charge

          (2) An applicant for a dealer’s licence may designate an individual as an alternate qualified person in charge, who is authorized to replace the qualified person in charge when that person is absent. The applicant may designate themself if the applicant is an individual.

        • Qualifications

          (3) Only an individual who meets the following requirements may be designated as a qualified person in charge or an alternate qualified person in charge:

          • (a) they work at the site specified in the dealer’s licence;

          • (b) they

            • (i) are entitled or, if applicable, registered and entitled by a provincial professional licensing authority or a professional association in Canada and entitled to practise a profession that is relevant to their duties, such as pharmacist, practitioner, pharmacy technician or laboratory technician,

            • (ii) hold a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to their duties, such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, chemistry, biology, pharmacy technician, laboratory technician, pharmaceutical regulatory affairs or supply chain management or security, or

            • (iii) hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (ii) and hold

              • (A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or

              • (B) an equivalency assessment issued by an organization or institution that is responsible for issuing equivalency assessments and is recognized by a province;

          • (c) they have sufficient knowledge of and experience with the use and handling of the targeted substances specified in the dealer’s licence to properly carry out their duties; and

          • (d) they have sufficient knowledge of the provisions of the Act and these Regulations that are applicable to the activities specified in the dealer’s licence to properly carry out their duties.

        • Exception

          (4) An applicant for a dealer’s licence may designate an individual who does not meet any of the requirements of paragraph (3)(b) as a qualified person in charge or an alternate qualified person in charge if

          • (a) no other individual working at the site meets those requirements;

          • (b) those requirements are not necessary for the activities specified in the licence; and

          • (c) the individual has sufficient knowledge — acquired from a combination of education, training or work experience — to properly carry out their duties.

      • Ineligibility

        16 An individual is not eligible to be a senior person in charge, a qualified person in charge or an alternate qualified person in charge if, during the 10 years before the day on which the dealer’s licence application is submitted,

        • (a) in respect of a designated substance offence or a designated criminal offence or a designated offence as defined in subsection 2(1) of the Cannabis Act, the individual

          • (i) was convicted as an adult, or

          • (ii) was a young person who received an adult sentence, as those terms are defined in subsection 2(1) of the Youth Criminal Justice Act; or

        • (b) in respect of an offence committed outside Canada that, if committed in Canada, would have constituted a designated substance offence or a designated criminal offence or a designated offence as defined in subsection 2(1) of the Cannabis Act,

          • (i) the individual was convicted as an adult, or

          • (ii) if they committed the offence when they were at least 14 years old but less than 18 years old, the individual received a sentence that was longer than the maximum youth sentence, as that term is defined in subsection 2(1) of the Youth Criminal Justice Act, that could have been imposed under that Act for such an offence.

      Issuance of Licence
      • Application
        • 17 (1) A person who intends to conduct an activity referred to in section 12 must obtain a dealer’s licence for each site at which they intend to conduct activities by submitting an application to the Minister that contains the following information:

          • (a) if the licence is requested by

            • (i) an individual, the individual’s name,

            • (ii) a corporation, its corporate name and any other name registered with a province under which it intends to conduct the activities specified in its dealer’s licence or by which it intends to identify itself, and

            • (iii) the holder of a position described in paragraph 13(c), the applicant’s name and the title of the position;

          • (b) the municipal address, telephone number and, if applicable, the email address of the proposed site and, if different from the municipal address, its mailing address;

          • (c) the name, date of birth, telephone number and email address of the proposed senior person in charge;

          • (d) with respect to each of the proposed qualified person in charge and any proposed alternate qualified person in charge,

            • (i) their name, date of birth, telephone number and email address,

            • (ii) the title of their position at the site,

            • (iii) the name and title of the position of their immediate supervisor at the site,

            • (iv) if applicable, the profession they practise that is relevant to their duties, the name of the province that authorizes them to practise it and their authorization number, and

            • (v) their education, training and work experience that are relevant to their duties;

          • (e) the activities that are to be conducted and the targeted substances in respect of which each of the activities is to be conducted;

          • (f) if the licence is requested to manufacture or assemble a product or compound that contains a targeted substance, other than a test kit, a list that includes, for each product or compound,

            • (i) the brand name of the product or the name of the compound,

            • (ii) the drug identification number that is assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any,

            • (iii) the specified name of the targeted substance in the product or compound,

            • (iv) the strength per unit of the targeted substance in it, the number of units per package and the number of packages,

            • (v) if it is to be manufactured or assembled by or for another licensed dealer under a custom order, the name, municipal address and licence number of the other licensed dealer, and

            • (vi) if the applicant’s name appears on the label of the product or compound, a copy of the inner label, as defined in section A.01.010 of the Food and Drug Regulations;

          • (g) if the licence is requested in order to produce a targeted substance other than a product or compound that contains a targeted substance,

            • (i) the specified name of the targeted substance,

            • (ii) the quantity that the applicant expects to produce under their licence and the period during which that quantity would be produced, and

            • (iii) if it is to be produced for another licensed dealer under a custom order, the name, municipal address and licence number of the other licensed dealer;

          • (h) if the licence is requested for an activity that is not described in paragraph (f) or (g), the specified name of the targeted substance for which the activity is to be conducted and the purpose of the activity;

          • (i) a detailed description of the security measures in place at the site, determined in accordance with the Security Directive; and

          • (j) a detailed description of the method for recording information that the applicant proposes to use for the purpose of section 40.

        • Documents

          (2) An application for a dealer’s licence must be accompanied by the following documents:

          • (a) if the applicant is a corporation, a copy of

            • (i) the certificate of incorporation or other constituting instrument, and

            • (ii) any document filed with the province in which its site is located that states its corporate name and any other name registered with the province under which the applicant intends to conduct the activities specified in its dealer’s licence or by which it intends to identify itself;

          • (b) individual declarations signed and dated by each of the proposed senior person in charge, and qualified person in charge and any proposed alternate qualified person in charge, attesting that the person is not ineligible for a reason specified in section 16;

          • (c) a document issued by a Canadian police force in relation to each person referred to in paragraph (b), indicating whether, during the 10 years before the day on which the application is submitted, the person was convicted as specified in subparagraph 16(a)(i) or received a sentence as specified in subparagraph 16(a)(ii);

          • (d) if any of the persons referred to in paragraph (b) has ordinarily resided in a country other than Canada during the 10 years before the day on which the application is submitted, a document issued by a police force of that country indicating whether in that period that person was convicted as specified in subparagraph 16(b)(i) or received a sentence as specified in subparagraph 16(b)(ii);

          • (e) a declaration, signed and dated by the proposed senior person in charge, attesting that the proposed qualified person in charge and any proposed alternate qualified person in charge have the knowledge and experience required under paragraphs 15(3)(c) and (d); and

          • (f) if the proposed qualified person in charge or any proposed alternate qualified person in charge does not meet the requirement of subparagraph 15(3)(b)(i), either

            • (i) a copy of the person’s diploma, certificate or credential referred to in subparagraph 15(3)(b)(ii) or (iii), or

            • (ii) a detailed description of the education, training and work experience that is required under paragraph 15(4)(c), together with supporting evidence, such as a copy of a course transcript or an attestation by the person who provided the training.

        • Signature and attestation

          (3) The application must

          • (a) be signed and dated by the proposed senior person in charge; and

          • (b) include an attestation by that person that

            • (i) all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and

            • (ii) they have the authority to bind the applicant.

        • 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.

      • Issuance

        17.1 Subject to section 17.3, on completion of the review of the licence application, the Minister must issue a dealer’s licence, with or without terms and conditions, that contains

        • (a) the licence number;

        • (b) the name of the licensed dealer, their corporate name or the title of the position they hold;

        • (c) the activities that are authorized and the specified names of the targeted substances in respect of which each activity may be conducted;

        • (d) the municipal address of the site at which the dealer may conduct the authorized activities;

        • (e) the security level at the site, determined in accordance with the Security Directive;

        • (f) the effective date of the licence;

        • (g) the expiry date of the licence, which must be not later than three years after its effective date;

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

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

          • (ii) ensure conformity with the requirements associated with the security level that is referred to in paragraph (e), or

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

        • (i) if the licensed dealer produces a targeted substance, the quantity that they may produce and the authorized production period.

      • Validity

        17.2 A dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section 23 or 24.

      • Refusal
        • 17.3 (1) The Minister must refuse to issue a dealer’s licence if

          • (a) the applicant may not apply for a licence under section 13;

          • (b) during the 10 years before the day on which the licence application is submitted, the applicant 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 applicant under any regulations made under the Act or issued to the applicant under the Cannabis Act or its regulations;

          • (c) during the 10 years before the day on which the application is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified as specified in subparagraph 16(a)(i) or (b)(i) or received a sentence as specified in subparagraph 16(a)(ii) or (b)(ii);

          • (d) an activity for which the licence is requested would contravene an international obligation;

          • (e) the applicant does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the licence is requested;

          • (f) the method referred to in paragraph 17(1)(j) does not permit the recording of information as required by section 40;

          • (g) the applicant has not complied with the requirements of subsection 17(4) or the information or documents that they have provided are not sufficient to complete the review of the licence application;

          • (h) the Minister has reasonable grounds to believe that the applicant has submitted false or misleading information or false or falsified documents in or in support of the licence application;

          • (i) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the applicant has been involved in the diversion of a targeted substance to an illicit market or use or has been involved in an activity that contravenes an international obligation; or

          • (j) the Minister has reasonable grounds to believe that the issuance of the licence would likely create a risk to public health or safety, including the risk of a targeted substance being diverted to an illicit market or use.

        • Exceptions

          (2) The Minister must not refuse to issue a licence under paragraph (1)(b) or (h) if the applicant 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 targeted substance from being diverted to an illicit market or use:

          • (a) the applicant does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and

          • (b) the applicant 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.

        • Notice

          (3) Before refusing to issue a licence, the Minister must send the applicant a notice that sets out the Minister’s reasons and gives the applicant an opportunity to be heard.

      Renewal of Licence
      • Application
        • 18 (1) To apply to renew a dealer’s licence, a licensed dealer must submit to the Minister an application that contains the information and documents referred to in subsections 17(1) and (2).

        • Signature and attestation

          (2) The application must

          • (a) be signed and dated by the senior person in charge of the site specified in the application; and

          • (b) include an attestation by that person that

            • (i) all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and

            • (ii) they have the authority to bind the licensed dealer.

        • 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.

      • Renewal
        • 18.1 (1) Subject to section 18.3, on completion of the review of the renewal application, the Minister must issue a renewed dealer’s licence that contains the information specified in section 17.1.

        • Terms and conditions

          (2) When renewing a dealer’s licence, the Minister may, if he or she has reasonable grounds to believe that it is necessary to do so, add a term or condition to it or modify or delete one in order 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 the new level required as a result of the licence renewal; or

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

      • Validity

        18.2 A renewed dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section 23 or 24.

      • Refusal
        • 18.3 (1) The Minister must refuse to renew a dealer’s licence if

          • (a) the licensed dealer may no longer apply for a licence under section 13;

          • (b) during the 10 years before the day on which the renewal application is submitted, 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;

          • (c) during the 10 years before the day on which the renewal application is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph 16(a)(i) or (b)(i) or received a sentence as specified in subparagraph 16(a)(ii) or (b)(ii);

          • (d) an activity for which the renewal is requested would contravene an international obligation;

          • (e) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the renewal is requested;

          • (f) the method referred to in paragraph 17(1)(j) does not permit the recording of information as required by section 40;

          • (g) the licensed dealer has not complied with the requirements of subsection 18(3) or the information or documents that they have provided are not sufficient to complete the review of the renewal application;

          • (h) 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 renewal application;

          • (i) 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 targeted substance to an illicit market or use or has been involved in an activity that contravened an international obligation; or

          • (j) the Minister has reasonable grounds to believe that the renewal of the licence would likely create a risk to public health or safety, including the risk of a targeted substance being diverted to an illicit market or use.

        • Exceptions

          (2) The Minister must not refuse to renew a licence under paragraph (1)(b) or (h) 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 targeted substance from being diverted to an illicit market or use:

          • (a) the licensed dealer does not have a history of non-compliance with the Act or 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.

        • Notice

          (3) Before refusing to renew 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.

      Amendment of Licence
      • Application
        • 19 (1) Before making a change affecting any information referred to in section 17.1 that is contained in their dealer’s licence, a licensed dealer must submit to the Minister an application to amend the licence that contains a description of the proposed amendment, as well as the information and documents referred to in section 17 that are relevant to the proposed amendment.

        • Signature and attestation

          (2) The application must

          • (a) be signed and dated by the senior person in charge of the site specified in the application; and

          • (b) include an attestation by that person that

            • (i) all of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and

            • (ii) they have the authority to bind the licensed dealer.

        • 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.

      • Amendment
        • 19.1 (1) Subject to section 19.3, on completion of the review of the amendment application, the Minister must amend the dealer’s licence.

        • Terms and conditions

          (2) When amending a dealer’s licence, the Minister may, if he or she has reasonable grounds to believe that it is necessary to do so, add a term or condition to it or modify or delete one in order 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 the new level required as a result of the amendment; or

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

      • Validity

        19.2 An amended dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section 23 or 24.

      • Refusal
        • 19.3 (1) The Minister must refuse to amend a dealer’s licence if

          • (a) an activity for which the amendment is requested would contravene an international obligation;

          • (b) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the amendment is requested;

          • (c) the method referred to in paragraph 17(1)(j) does not permit the recording of information as required by section 40;

          • (d) the licensed dealer has not complied with the requirements of subsection 19(3) or the information or documents that they have provided are not sufficient to complete the review of the amendment 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 amendment application; or

          • (f) the Minister has reasonable grounds to believe that the amendment of the licence would likely create a risk to public health or safety, including the risk of a targeted substance being diverted to an illicit market or use.

        • Exceptions

          (2) The Minister must not refuse to amend a licence under paragraph (1)(e) 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 targeted substance 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.

        • Notice

          (3) Before refusing to amend 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.

      Changes Requiring Prior Approval by Minister
      • Application
        • 20 (1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written application to the Minister:

          • (a) a change affecting the security measures in place at the site specified in the dealer’s licence;

          • (b) the replacement of the senior person in charge;

          • (c) the replacement of the qualified person in charge; or

          • (d) the replacement or addition of an alternate qualified person in charge.

        • Information and documents

          (2) The licensed dealer must provide the Minister with the following with respect to a change referred to in subsection (1):

          • (a) in the case of a change affecting the security measures in place at the site specified in the dealer’s licence, details of the change;

          • (b) in the case of the senior person in charge,

            • (i) the information specified in paragraph 17(1)(c), and

            • (ii) the declaration specified in paragraph 17(2)(b) and the documents specified in paragraphs 17(2)(c) and (d); and

          • (c) in the case of the qualified person in charge or an alternate qualified person in charge,

            • (i) the information specified in paragraph 17(1)(d), and

            • (ii) the declarations specified in paragraphs 17(2)(b) and (e) and the documents specified in paragraphs 17(2)(c), (d) and (f).

        • 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.

      • Approval
        • 20.1 (1) Subject to section 20.2, on completion of the review of the application for approval of the change, the Minister must approve the change.

        • Terms and conditions

          (2) When approving a change, the Minister may, if he or she has reasonable grounds to believe that it is necessary to do so, add a term or condition to the licence or modify or delete one in order 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 targeted substance being diverted to an illicit market or use.

      • Refusal
        • 20.2 (1) The Minister must refuse to approve the change if

          • (a) during the 10 years before the day on which the application for approval of the change is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph 16(a)(i) or (b)(i) or received a sentence as specified in subparagraph 16(a)(ii) or (b)(ii);

          • (b) the licensed dealer has not complied with the requirements of subsection 20(3) or the information or documents that they have provided are not sufficient to complete the review of the application for approval of the change;

          • (c) 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 application for approval of the change; or

          • (d) the Minister has reasonable grounds to believe that the change would likely create a risk to public health or safety, including the risk of a targeted substance being diverted to an illicit market or use.

        • Exceptions

          (2) The Minister must not refuse to approve a change under paragraph (1)(c) if 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, 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 targeted substance from being diverted to an illicit market or use.

        • Notice

          (3) Before refusing to approve a change, 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 in respect of them.

      Changes Requiring Notice to Minister
      • Prior notice
        • 21 (1) A licensed dealer must notify the Minister in writing before

          • (a) manufacturing or assembling a product or compound that is not set out in the most recent version of the list referred to in paragraph 17(1)(f) that has been submitted to the Minister; or

          • (b) making a change to a product or compound that is set out in the list, if the change affects any of the information that has previously been submitted.

        • Information and list

          (2) The notice must contain the information referred to in paragraph 17(1)(f) that is necessary to update the list and must be accompanied by the revised version of the list.

      • Notice — five days

        21.1 A licensed dealer must notify the Minister in writing within five days after a person ceases to act as the qualified person in charge or an alternate qualified person in charge.

      • Notice — 10 days
        • 21.2 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:

          • (a) a person ceases to act as the senior person in charge; or

          • (b) the licensed dealer ceases to manufacture or assemble a product or compound that is set out in the most recent version of the list referred to in paragraph 17(1)(f) that has been submitted to the Minister.

        • Information and list

          (2) A notice submitted under paragraph (1)(b) must specify which information referred to in paragraph 17(1)(f) is being changed and must be accompanied by the revised version of the list.

      • Notice of cessation of activities
        • 21.3 (1) A licensed dealer that intends to cease conducting activities at their site — whether on or before the expiry of their licence — must notify the Minister in writing to that effect at least 30 days before ceasing those activities.

        • Content of notice

          (2) The notice must be signed and dated by the senior person in charge and contain the following information:

          • (a) the expected date of the cessation of activities at the site;

          • (b) a description of the manner in which any remaining targeted substances on the site as of that date will be disposed of by the licensed dealer, including

            • (i) if some or all of them will be sold or provided to another licensed dealer that will be conducting activities at the same site, the name of that dealer,

            • (ii) if some or all of them will be sold or provided to another licensed dealer that will not be conducting activities at the same site, the name of that dealer and the municipal address of their site, and

            • (iii) if some or all of them will be destroyed, the date on which and the municipal address of the location at which the destruction is to take place;

          • (c) the municipal address of the location at which the licensed dealer’s documents will be kept after activities have ceased; and

          • (d) the name, municipal address, telephone number and, if applicable, the email address of a person who the Minister may contact for further information after activities have ceased.

        • Update

          (3) After having ceased to conduct the activities, the licensed dealer must submit to the Minister a detailed update of the information referred to in subsection (2) if it differs from what was set out in the notice. The update must be signed and dated by the senior person in charge.

      Changes to Terms and Conditions of Licence
      • Addition of or modification to term or condition
        • 22 (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 targeted substance being diverted to an illicit market or use.

        • 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.

        • 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 targeted substance from being diverted to an illicit market or use.

        • 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.

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

        • 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
      • Suspension
        • 23 (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 targeted substance from being diverted to an illicit market or use.

        • 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.

        • 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.

      • Revocation
        • 24 (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 13;

          • (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 as specified in subparagraph 16(a)(i) or (b)(i) or received a sentence as specified in subparagraph 16(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 targeted substance to an illicit market or use.

        • 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 targeted substance 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.

        • 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.

      • Return of licence

        24.1 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

      • Application
        • 25 (1) A licensed dealer must submit to the Minister, before each importation of a targeted substance, 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 targeted substance to be imported,

            • (i) its specified name, as set out 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 targeted substance 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 of the Food and Drug Regulations, if any, and

            • (iii) the strength per unit of the targeted substance 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 targeted substance 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.

        • 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.

        • 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.

      • Issuance

        25.1 Subject to section 25.4, 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 25(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 targeted substance being diverted to an illicit market or use.

      • Validity

        25.2 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 26 or 27,

        • (c) the date of the suspension or revocation of the dealer’s licence under section 23 or 24, and

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

      • Return of permit

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

      • Refusal
        • 25.4 (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 targeted substance 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 25(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 targeted substance being diverted to an illicit market or use.

        • 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.

      • Providing copy of permit

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

      • Declaration

        25.6 The holder of an import permit must provide the Minister, within 15 days after the day of release of the targeted substance 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 targeted substance;

        • (b) with respect to the targeted substance,

          • (i) its specified 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 targeted substance 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 of the Food and Drug Regulations, if any, and

          • (iii) the strength per unit of the targeted substance 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 targeted substance was released and the date of the release.

      • Suspension
        • 26 (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 targeted substance 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.

        • 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.

        • 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.

      • Revocation
        • 27 (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 26(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 targeted substance to an illicit market or use; or

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

        • Exceptions

          (2) The Minister must not revoke an import permit for a ground set out in paragraph (1)(d) or 24(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 targeted substance 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.

        • 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.

      • Return of permit

        27.1 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

      • Application
        • 28 (1) A licensed dealer must submit to the Minister, before each exportation of a targeted substance, 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 targeted substance to be exported,

            • (i) its specified name, as set out 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 targeted substance 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 of the Food and Drug Regulations, if any, and

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

          • (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.

        • 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.

        • 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.

      • Issuance

        28.1 Subject to section 28.4, 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 28(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 targeted substance being diverted to an illicit market or use.

      • Validity

        28.2 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 29 or 30,

        • (c) the date of the suspension or revocation of the dealer’s licence under section 23 or 24, and

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

      • Return of permit

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

      • Refusal
        • 28.4 (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 targeted substance 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 28(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 targeted substance being diverted to an illicit market or use.

        • 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.

      • Providing copy of permit

        28.5 The holder of an export permit must provide a copy of the permit to the customs office at the time of exportation.

      • Declaration

        28.6 The holder of an export permit must provide the Minister, within 15 days after the day of export of the targeted substance 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 targeted substance;

        • (b) with respect to the targeted substance,

          • (i) its specified 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 targeted substance 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 of the Food and Drug Regulations, if any, and

          • (iii) the strength per unit of the targeted substance 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 targeted substance was exported and the date of export.

      • Suspension
        • 29 (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 targeted substance 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.

        • 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.

        • 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.

      • Revocation
        • 30 (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 29(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 targeted substance to an illicit market or use; or

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

        • Exceptions

          (2) The Minister must not revoke an export permit for a ground set out in paragraph (1)(d) or 24(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 targeted substance 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.

        • 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.

      • Return of permit

        30.1 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

      • Name

        31 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 targeted substances, including labels, orders, shipping documents, invoices and advertising.

      Sale of Targeted Substances

      • Specified persons
        • 32 (1) Subject to subsection (2), a licensed dealer may sell or provide a targeted substance to

          • (a) another licensed dealer;

          • (b) a pharmacist;

          • (c) a practitioner;

          • (d) a hospital;

          • (e) a person to whom an exemption relating to the substance has been granted under section 56 of the Act; or

          • (f) the Minister.

        • Exception — pharmacist or practitioner named in notice

          (2) The licensed dealer must not sell or provide a targeted substance to a pharmacist or practitioner named in a notice issued under section 79, unless the dealer has received a notice of retraction issued under section 80.

      • Order required
        • 33 (1) A licensed dealer may sell or provide a targeted substance in accordance with section 32 if the dealer has received from one of the following persons a written or verbal order indicating the specified name and the quantity of the substance and, in the case of a written order, the conditions specified in subsection (2) are met:

          • (a) in the case of a licensed dealer, a person who is authorized to place an order for the substance on their behalf;

          • (b) in the case of a hospital, the pharmacist in charge of the hospital’s pharmacy or a practitioner authorized by the person in charge of the hospital to sign the order; or

          • (c) in any other case, the person to whom the substance is to be sold or provided.

        • Conditions

          (2) The following conditions apply to a written order:

          • (a) it must be signed and dated by one of the persons referred to in subsection (1); and

          • (b) the licensed dealer must verify the signature if it is unknown to them.

      • Anticipated multiple sales
        • 33.1 (1) A licensed dealer may sell or provide a targeted substance more than once in respect of one order if the order indicates

          • (a) the number of sales or provisions, not exceeding four;

          • (b) the specific quantity for each sale or provision; and

          • (c) the intervals between each sale and provision.

        • Multiple sales — insufficient stock

          (2) A licensed dealer may sell or provide a targeted substance more than once in respect of one order if, at the time of receipt of the order, the dealer temporarily does not have in stock the quantity of the substance ordered, in which case the dealer may sell or provide against the order the quantity of the substance that the dealer has available and deliver the balance later.

      Packaging and Transportation

      • Packaging — sale and provision
        • 34 (1) A licensed dealer that sells or provides a targeted substance 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.

        • Packaging — transport and export

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

        • Exception

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

      • Transport

        34.1 A licensed dealer must, in taking delivery of a targeted substance that they have imported or in making delivery of a targeted substance,

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

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

        • (c) in the case of a targeted substance that is to be exported, transport it directly from the site specified in their licence to the customs office where it will be exported.

      Thefts, Losses and Suspicious Transactions

      • Protective measures

        35 A licensed dealer must take any measures that are necessary to ensure the security of any targeted substance in their possession and any licence or permit in their possession.

      • Theft or loss — licences and permits

        35.1 A licensed dealer that becomes aware of a theft or loss of their licence or permit must provide a written report to the Minister within 72 hours after becoming aware of it.

      • Theft or unexplainable loss — targeted substances

        35.2 A licensed dealer that becomes aware of a theft of a targeted substance or of a loss of a targeted substance that cannot be explained on the basis of normally accepted business activities must

        • (a) provide a written report to a member of a police force within 24 hours after becoming aware of the theft or loss; and

        • (b) provide a written report to the Minister within 72 hours after becoming aware of the theft or loss and include a confirmation that the report required under paragraph (a) has been provided.

      • Suspicious transaction
        • 35.3 (1) A licensed dealer must provide a written report containing the following information to the Minister within 72 hours after becoming aware of a transaction occurring in the course of their activities that they have reasonable grounds to suspect may be related to the diversion of a targeted substance to an illicit market or use:

          • (a) their name, municipal address, telephone number and, if the licensed dealer is a corporation, the position held by the individual making the report;

          • (b) the name and municipal address of the other party to the transaction;

          • (c) details of the transaction, including its date and time, its type, the specified name and quantity of the targeted substance and, in the case of a product or compound, the quantity of every targeted substance that it contains;

          • (d) in the case of a product that contains the targeted substance, other than a test kit, the drug identification number that is assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any; and

          • (e) a detailed description of the reasons for those suspicions.

        • Good faith

          (2) No civil proceedings lie against a licensed dealer for having provided the report in good faith.

        • Non-disclosure

          (3) A licensed dealer must not disclose that they have provided the report or disclose details of it, with the intent to prejudice a criminal investigation, whether or not a criminal investigation has begun.

      • Partial protection against self-incrimination

        35.4 A report made under any of sections 35.1 to 35.3, or any evidence derived from it, is not to be used or received to incriminate the licensed dealer in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

      Destruction of Targeted Substances

      • Destruction at site

        36 A licensed dealer that intends to destroy a targeted substance at the site specified in their licence must ensure that the following conditions are met:

        • (a) the licensed dealer obtains the prior approval of the Minister;

        • (b) the destruction is carried out in the presence of two of the following persons, at least one of whom must be a person referred to in subparagraph (i):

          • (i) the senior person in charge, the qualified person in charge or an alternate qualified person in charge, and

          • (ii) a person who works for or provides services to the licensed dealer and holds a senior position;

        • (c) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and

        • (d) as soon as the destruction is completed, the person who carried out the destruction and each of the two persons referred to in paragraph (b) who were present at the destruction sign and date a joint declaration attesting that the targeted substance was completely destroyed, to which each signatory must add their name in printed letters.

      • Destruction elsewhere than at site

        37 A licensed dealer that intends to destroy a targeted substance elsewhere than at the site specified in their licence must ensure that the following conditions are met:

        • (a) the licensed dealer obtains the prior approval of the Minister to carry out the destruction;

        • (b) the licensed dealer takes any measures that are necessary to ensure the security of the targeted substance while it is being transported in order to prevent its diversion to an illicit market or use;

        • (c) the destruction is carried out by a person working for a business that specializes in the destruction of dangerous goods and in the presence of another person working for that business;

        • (d) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and

        • (e) as soon as the destruction is completed, the person who carried out the destruction provides the licensed dealer with a dated declaration attesting that the targeted substance was completely destroyed and containing

          • (i) the municipal address of the place of destruction,

          • (ii) the specified name and quantity of the targeted substance and, if applicable, the brand name and quantity of the product containing it or the name and quantity of the compound containing it,

          • (iii) the method of destruction,

          • (iv) the date of destruction, and

          • (v) the names in printed letters and signatures of that person and the other person who was present at the destruction.

      • Application for prior approval
        • 38 (1) A licensed dealer must submit to the Minister an application that contains the following information in order to obtain the Minister’s prior approval to destroy a targeted substance:

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

          • (b) the proposed date of destruction;

          • (c) the municipal address of the place of destruction;

          • (d) a brief description of the method of destruction;

          • (e) if the destruction is to be carried out at the site specified in the dealer’s licence, the names of the persons proposed for the purpose of paragraph 36(b) and information establishing that they meet the conditions of that paragraph;

          • (f) the specified name of the targeted substance and, if applicable, the brand name of the product containing it or the name of the compound containing it; and

          • (g) the form and quantity of the targeted substance or the product or compound containing it and, if applicable, the strength per unit of the targeted substance in the product or compound, the number of units per package and the number of packages.

        • 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

            • (i) the proposed method of destruction complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction, and

            • (ii) all of the information submitted in support of the application is correct and complete to the best of the signatory’s knowledge.

        • 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.

      • Approval

        39 On completion of the review of the approval application, the Minister must approve the destruction of the targeted substance unless

        • (a) in the case of a destruction that is to be carried out at the site specified in the dealer’s licence, the persons proposed for the purpose of paragraph 36(b) do not meet the conditions of that paragraph;

        • (b) the Minister has reasonable grounds to believe that the targeted substance would not be destroyed;

        • (c) 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 approval application;

        • (d) the targeted substance or a portion of it is required for the purposes of a criminal or administrative investigation or a preliminary inquiry, trial or other proceeding under any Act or its regulations; or

        • (e) the Minister has reasonable grounds to believe that the approval 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.

      Documents

      • Method of recording information

        40 A licensed dealer must record any information that they are required to record under these Regulations using a method that permits an audit of it to be made at any time.

      • Information — general

        41 A licensed dealer must record the following information:

        • (a) the specified name, the form and the quantity of any targeted substance that the dealer orders, the name of the person who placed the order on the dealer’s behalf and the date of the order;

        • (b) the specified name, the form and the quantity of any targeted substance that the dealer receives, the name and municipal address of the person who sold or provided it and the date on which it was received;

        • (c) in the case of a targeted substance that the dealer sells or provides,

          • (i) the brand name of the product or the name of the compound containing the targeted substance and the specified name of the targeted substance,

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

          • (iii) the form and quantity of the targeted substance and, if applicable, the strength per unit of the targeted substance in the product or compound, the number of units per package and the number of packages,

          • (iv) the name and municipal address of the person to whom it was sold or provided, and

          • (v) the date on which it was sold or provided;

        • (d) the specified name, the form and the quantity of any targeted substance that the dealer produces and the date on which it was placed in stock and, if applicable, the strength per unit of the targeted substance in the product or compound, the number of units per package and the number of packages;

        • (e) the specified name and the quantity of any targeted substance that the dealer uses in the manufacturing or assembling of a product or compound, as well as the brand name and quantity of the product or the name and quantity of the compound, and the date on which the product or compound was placed in stock;

        • (f) the specified name, the form and the quantity of any targeted substance in stock at the end of each month;

        • (g) the specified name, the form and the quantity of any targeted substance that the dealer delivers, transports or sends, the name and municipal address of the consignee and the date on which it was delivered, transported or sent;

        • (h) the specified name, the form and the quantity of any targeted substance that the dealer imports, the date on which it was imported, the name and municipal address of the exporter, the country of exportation and any country of transit or transhipment; and

        • (i) the specified name, the form and the quantity of any targeted substance that the dealer exports, the date on which it was exported, the name and municipal address of the importer, the country of final destination and any country of transit or transhipment.

      • Verbal order

        42 A licensed dealer that receives a verbal order for a targeted substance must immediately record the following information:

        • (a) the name of the person who placed the order;

        • (b) the date on which the order was received; and

        • (c) the name of the person recording the order.

      • Explainable loss of targeted substance

        43 A licensed dealer that becomes aware of a loss of a targeted substance that can be explained on the basis of normally accepted business activities must record the following information:

        • (a) the name of the lost targeted substance and, if applicable, the brand name of the product or the name of the compound containing it;

        • (b) the form and quantity of the targeted substance and, if applicable, the form of the product or compound containing it, the strength per unit of the targeted substance in the product or compound, the number of units per package and the number of packages;

        • (c) the date on which the dealer became aware of the loss; and

        • (d) the explanation for the loss.

      • Destruction

        44 A licensed dealer must record the following information concerning any targeted substance that they destroy at the site specified in their licence:

        • (a) the municipal address of the place of destruction;

        • (b) the specified name, the form and the quantity of the targeted substance and, if applicable, the brand name and quantity of the product containing the targeted substance or the name and quantity of the compound containing the targeted substance;

        • (c) the method of destruction; and

        • (d) the date of destruction.

      • Annual report
        • 45 (1) Subject to subsections (2) and (3), a licensed dealer must provide to the Minister, within three months after the end of each calendar year, an annual report that contains

          • (a) the specified name, the form and the total quantity of each targeted substance that they receive, produce, assemble, sell, provide, import, export or destroy during the calendar year, as well as the name and total quantity of each targeted substance that they use to manufacture or assemble a product or compound;

          • (b) the specified name, the form and the quantity of each targeted substance in physical inventory taken at the site specified in their licence at the end of the calendar year; and

          • (c) the specified name, the form and the quantity of any targeted substance that has been lost or stolen in the course of conducting activities during the calendar year.

        • Non-renewal or revocation within first three months

          (2) If a licensed dealer’s licence expires without being renewed or is revoked during the first three months of a calendar year, the dealer must provide to the Minister

          • (a) within three months after the end of the preceding calendar year, the annual report in respect of that year; and

          • (b) within three months after the expiry or revocation, a report in respect of the portion of the current calendar year during which the licence was valid that contains the information referred to in subsection (1), in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

        • Non-renewal or revocation after third month

          (3) If a licensed dealer’s licence expires without being renewed or is revoked after the first three months of a calendar year, the dealer must provide to the Minister, within three months after the expiry or revocation, a report in respect of the portion of the calendar year during which the licence was valid that contains the information referred to in subsection (1) for that period, in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

  • — SOR/2019-170, s. 3

    • 3 The heading “PART 2” before section 48 of the Regulations is repealed.

  • — SOR/2019-170, s. 4

    • 4 Sections 48 and 49 of the Regulations are replaced by the following:

      • Application

        48 Sections 49 to 56 do not apply to a pharmacist when they are practising in a hospital.

      • Authorization

        49 A pharmacist may, in accordance with sections 50 to 57, compound a targeted substance in accordance with a prescription.

  • — SOR/2019-170, s. 5

      • 5 (1) Paragraph 51(2)(c) of the Regulations is replaced by the following:

        • (c) the name of the individual for whose benefit the targeted substance is sold or provided or, if it is sold or provided for the benefit of an animal, the name of the individual having caring of the animal or the name of the animal;

      • (2) Subparagraph 51(3)(a)(i) of the Regulations is replaced by the following:

        • (i) the name and address of the individual for whose benefit the prescription is provided or, if it is provided for the benefit of an animal, the name and address of the individual having caring of the animal and, if applicable, the name of the animal,

  • — SOR/2019-170, s. 6

    • 6 Paragraph 55(1)(d) of the French version of the Regulations is replaced by the following:

      • d) la personne qui bénéficie d’une exemption relative à la substance ciblée et accordée en vertu de l’article 56 de la Loi, si la commande est faite par écrit et accompagnée d’une copie de l’exemption.

  • — SOR/2019-170, s. 7

    • 7 The heading “PART 3” before section 58 of the Regulations is repealed.

  • — SOR/2019-170, s. 8

    • 8 Section 59 of the French version of the Regulations is replaced by the following:

      • Approvisionnement d’urgence
        • 59 (1) Le médecin peut entreposer un approvisionnement d’urgence de substances ciblées en un lieu éloigné où des traitements médicaux d’urgence ne sont pas aisément disponibles ou dans un véhicule de service médical d’urgence, s’il s’y fait représenter par un mandataire qui aura le contrôle des substances ciblées et qui les administrera au nom du médecin et selon ses directives.

        • Urgences

          (2) Dans le cas où des soins sont donnés à une personne physique dans une situation d’urgence, le mandataire du médecin peut administrer à la personne une substance ciblée faisant partie de l’approvisionnement d’urgence :

          • a) soit si le médecin lui en donne l’ordre par téléphone ou autrement;

          • b) soit si le mandataire se conforme aux directives écrites du médecin relatives à l’administration de la substance ciblée.

  • — SOR/2019-170, s. 9

      • 9 (1) Subsection 61(1) of the French version of the Regulations is replaced by the following:

        • Obligations du mandataire
          • 61 (1) Le mandataire du médecin visé au paragraphe 59(1) satisfait aux exigences suivantes :

            • a) il prend des mesures raisonnables pour protéger toute substance ciblée en sa possession contre la perte et le vol;

            • b) il avise sans délai le médecin de la perte ou du vol de toute substance ciblée.

      • (2) Subsection 61(2) of the Regulations is replaced by the following:

        • Obligations — practitioner of medicine

          (2) A practitioner of medicine who is informed by their agent or mandatary of the loss or theft of a targeted substance must inform the Minister in accordance with subsection 72(2).

  • — SOR/2019-170, s. 10

    • 10 The heading “PART 4” before section 63 of the Regulations is repealed.

  • — SOR/2019-170, s. 11

    • 11 Subsection 63(1) of the Regulations is replaced by the following:

      • Authorization
        • 63 (1) A hospital may, in accordance with subsection (2) and sections 64 to 67, sell, provide, administer, send, deliver or transport a targeted substance.

  • — SOR/2019-170, s. 12

    • 12 The portion of paragraph 65(1)(c) of the French version of the Regulations before subparagraph (i) is replaced by the following:

      • c) la personne qui bénéficie d’une exemption relative à la substance ciblée et accordée en vertu de l’article 56 de la Loi, si :

  • — SOR/2019-170, s. 13

    • 13 The heading “PART 5” before section 68 of the Regulations is repealed.

  • — SOR/2019-170, s. 14

      • 14 (1) Subparagraphs 68(1)(b)(i) and (ii) of the French version of the Regulations are replaced by the following:

        • (i) soit pour son utilisation personnelle,

        • (ii) soit pour l’utilisation personnelle d’une personne physique dont il est responsable et qui l’accompagne,

      • (2) Subparagraph 68(1)(b)(iii) of the Regulations is replaced by the following:

        • (iii) for the use of an animal for which the individual is responsible and that is travelling with them;

  • — SOR/2019-170, s. 15

      • 15 (1) Subparagraphs 69(b)(i) and (ii) of the French version of the Regulations are replaced by the following:

        • (i) soit pour son utilisation personnelle,

        • (ii) soit pour l’utilisation personnelle d’une personne physique dont elle est responsable et qui l’accompagne,

      • (2) Subparagraph 69(b)(iii) of the Regulations is replaced by the following:

        • (iii) for the use of an animal for which the individual is responsible and that is travelling with them;

  • — SOR/2019-170, s. 16

    • 16 The headings before section 70 and sections 70 to 82 of the Regulations are replaced by the following:

      Verification of Identity

      • Order

        70 Every person who fills an order or prescription for a targeted substance must verify the identity of the person who gave the order or issued the prescription if

        • (a) the signature on the order or prescription is unknown to the person; or

        • (b) the order or prescription is verbal and the person placing it is not known to the person.

      Storage

      • Place

        71 Subject to section 59, every person who is authorized under these Regulations to deal in a targeted substance and who stores the targeted substance must do so in the place used for the purpose of conducting their business or professional practice and in the area in that place where only authorized employees have access, except if the targeted substance is for their own use or the use of another person for whom, or an animal for which, they are responsible.

      Security

      • Protective measures
        • 72 (1) The following persons must take any measures that are necessary to ensure the security of any targeted substance in their possession:

          • (a) a pharmacist;

          • (b) a practitioner;

          • (c) the person in charge of a hospital;

          • (d) a person to whom an exemption has been granted under section 56 of the Act; and

          • (e) a person who, in accordance with a permit for transit or transhipment, is responsible for the targeted substance while it is in transit or in transhipment in Canada.

        • Theft or loss

          (2) A person referred to in subsection (1) who becomes aware of a theft or loss of a targeted substance must provide a written report to the Minister within 10 days after becoming aware of the occurrence.

      Destruction

      • Restriction
        • 73 (1) Subject to subsection (2) and sections 36 and 37, a person must not destroy a targeted substance unless they have received it in accordance with these Regulations for their own use or the use of another person for whom, or an animal for which, they are responsible.

        • Conditions

          (2) A pharmacist, a practitioner or the person in charge of a hospital may destroy a targeted substance if

          • (a) subject to subsection (3), the destruction is witnessed by a pharmacist or practitioner;

          • (b) the targeted substance is destroyed using a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction;

          • (c) they record the following information:

            • (i) the municipal address of the place of destruction,

            • (ii) the specified name of the targeted substance to be destroyed and, if applicable, the brand name of the product containing it or the name of the compound containing it,

            • (iii) the form and quantity of the targeted substance to be destroyed or the product or compound containing it and, if applicable, its strength per unit, the number of units per package and the number of packages,

            • (iv) the method of destruction, and

            • (v) the date of the destruction; and

          • (d) immediately following the destruction, the person who carried out the destruction and the pharmacist or practitioner who witnessed it sign and date a joint declaration attesting that the targeted substance was completely destroyed, to which each signatory must add their name in printed letters.

        • Exception — open ampule

          (3) A targeted substance that constitutes the remainder of an open ampule, the partial contents of which have been administered to a patient, may be destroyed by a hospital employee who is a licensed health professional without a witness.

      Documents

      • Alteration prohibited

        74 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.

      • Retention period

        75 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.

      • Location

        76 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.

      • Quality of documents

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

      Advertising

      • Restrictions

        78 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

      • Notice of prohibition of sale
        • 79 (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.

        • 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.

        • 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.

        • 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.

        • 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.

      • Prohibition of sale — notice of retraction

        80 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.

      • Communication of information by Minister to licensing authority
        • 81 (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.

        • Definition of nurse

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

      Notification of Application for Order of Restoration

      • Written notification
        • 82 (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.

        • 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

      • Application
        • 83 (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.

        • 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.

        • 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.

        • 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.

      • Issuance
        • 84 (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.

        • 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.

  • — SOR/2019-170, s. 17

    • 17 Schedule 1 to the Regulations is amended by replacing the references after the heading “SCHEDULE 1” with the following:

      (Subsection 1(1) and section 3)
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