Interpretation

Marginal note:Definitions

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

  Act

  Loi

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

  adult

  adulte

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

  advertisement

  publicité

  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

  conjoint de fait

  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 

  ministère

  Department means the Department of Health. (ministère)

  designated drug offence

  infraction désignée en matière de drogue

  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

  véhicule de service médical d’urgence

  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

  permis d’exportation

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

  hospital

  hôpital

  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 

  permis d’importation

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

  international obligation 

  obligation internationale

  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 

  distributeur autorisé

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

  midwife

  sage-femme

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

  nurse practitioner

  infirmier praticien

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

  package 

  emballage

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

  pharmacist 

  pharmacien

  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

  podiatre

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

  prescription 

  ordonnance

  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 

  personne qualifiée responsable

  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 

  Directive en matière de sécurité

  Security Directive means the Directive on Physical Security Requirements for Controlled Substances (Security Requirements for Licensed Dealers for the Storage of Controlled Substances) published by the Department, as amended from time to time. (Directive en matière de sécurité)

  specified name 

  nom spécifié

  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

  substance ciblée

  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 

  nécessaire d’essai

  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 

  transbordement

  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.

Destruction

Marginal note:Prohibition

• 2 (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.

Advertising

Marginal note:Restrictions

3 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:

    

Class 2 Targeted Substances

Marginal note:Obtaining the targeted substance

• 4 (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.

Security

Marginal note:Verification of identity

5 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

6 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

• 7 (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

8 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

9 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

• 10 (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.

Marginal note:Further information

11 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

12 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

• 13 (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

14 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

• 15 (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

• 16 (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.

Marginal note:Multiple deliveries

17 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.

Eligibility

Marginal note:Eligible persons

18 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

• 19 (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.

Application for a Dealer’s Licence

Marginal note:Information and documents

• 20 (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.

Issuance of a Dealer’s Licence

Marginal note:Content of licence

21 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.

Grounds for Refusal

Marginal note:Refusal of the Minister

22 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.

Expiration

Marginal note:Duration of dealer’s licence

23 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

• 24 (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).

Amendment of Dealer’s Licence

Marginal note:Application for amendment

• 25 (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.

Changes in Information Provided

Marginal note:Prior approval or notice

• 26 (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.

Revocation or Suspension of Dealer’s Licence

Marginal note:Revocation

27 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.

Marginal note:Other revocation circumstances

• 28 (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.

Marginal note:Suspension

29 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.

General Obligations of Licensed Dealers

Marginal note:Identification

30 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.

Marginal note:Safekeeping during transportation

31 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.

Marginal note:Qualified person present

32 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

• 33 (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.

Marginal note:Application for approval to destroy

• 34 (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).

Records, Books, Electronic Data and Other Documents

Marginal note:Required information

35 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.

Importation

Application for an Import Permit

Marginal note:Required information and documents

• 36 (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.

Issuance of an Import Permit

Marginal note:Content of permit

• 37 (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.

Marginal note:Refusal of permit

38 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.

Provision of Copy

Marginal note:Copy of the permit

39 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

40 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

• 41 (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.

Exportation

Application for an Export Permit

Marginal note:Required information and documents

• 42 (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.

Issuance of an Export Permit

Marginal note:Content of permit

• 43 (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.

Marginal note:Refusal of permit

44 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.

Provision of Copy

Marginal note:Copy of the permit

45 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

46 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

• 47 (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.

PART 2Pharmacists

Permitted Activities

Marginal note:Application

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

Marginal note:Authorization

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

Marginal note:Record of receipt from licensed dealer

50 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.

Marginal note:Prescription required

• 51 (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.

Marginal note:Refills

52 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

53 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

• 54 (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.

Marginal note:Activities without a prescription

• 55 (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.

General Obligations of Pharmacists

Marginal note:Change of location

56 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

• 57 (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

58 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.

Marginal note:Emergency supply

• 59 (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.

Marginal note:Records — practitioner

• 60 (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.

Marginal note:Obligations — agents

• 61 (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.

Marginal note:Request for renunciation

62 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.

PART 4Hospitals

Marginal note:Authorization

• 63 (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

64 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.

Marginal note:Supply to non-patients

• 65 (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

66 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.

Marginal note:Closure

67 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.

PART 5Individuals

Marginal note:Importation — Canadian residents

• 68 (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

69 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

• 70 (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.

Marginal note:Application for a registration number

• 71 (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.

Marginal note:Issuance of a registration number

• 72 (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).

Marginal note:Effect of the registration number

73 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.

Marginal note:Cancellation

• 74 (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.

Marginal note:Application for a new number

• 75 (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

76 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

• 77 (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.

Marginal note:Permit for transit or transhipment

• 78 (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.

PART 8Minister

Marginal note:Notice to cease providing targeted substances

• 79 (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.

Marginal note:Retraction

80 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.

Marginal note:Provision of information

81 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.

PART 9Coming into Force

Marginal note:Coming into force

• 82 (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.