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Narcotic Control Regulations (C.R.C., c. 1041)

Regulations are current to 2019-11-19 and last amended on 2019-06-17. Previous Versions

AMENDMENTS NOT IN FORCE

  • — SOR/2019-169, s. 1

  • — SOR/2019-169, s. 2

    • 2 Section 1 of the Regulations and the heading before it are repealed.

  • — SOR/2019-169, s. 3

    • 3 The heading before section 2 and sections 2 to 29 of the Regulations are replaced by the following:

      Interpretation

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

          Act

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

          advertisement

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

          common-law partner

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

          competent authority

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

          compound

          compound includes a preparation. (composé)

          designated criminal offence

          designated criminal offence means

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

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

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

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

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

          destroy

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

          diacetylmorphine (heroin)

          diacetylmorphine (heroin) includes the salts of diacetylmorphine. (diacétylmorphine (héroïne))

          hospital

          hospital means a facility

          • (a) that is licensed, approved or designated by a province in accordance with the laws of the province to provide care or treatment to persons or animals suffering from any form of disease or illness; or

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

          international obligation

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

          licensed dealer

          licensed dealer means the holder of a licence issued under section 10.1. (distributeur autorisé)

          methadone

          methadone includes the salts of methadone. (méthadone)

          midwife

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

          narcotic

          narcotic means, subject to subsection (2),

          • (a) a controlled substance set out in the schedule; or

          • (b) in respect of a midwife, nurse practitioner or podiatrist, a controlled substance set out in the schedule that the midwife, nurse practitioner or podiatrist may prescribe, possess or conduct an activity with, in accordance with sections 3 and 4 of the New Classes of Practitioners Regulations. (stupéfiant)

          nurse practitioner

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

          pharmacist

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

          podiatrist

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

          prescription

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

          qualified person in charge

          qualified person in charge means the individual designated under subsection 9.2(1). (responsable qualifié)

          Security Directive

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

          senior person in charge

          senior person in charge means the individual designated under section 9.1. (responsable principal)

          test kit

          test kit means a kit

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

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

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

          verbal prescription narcotic

          verbal prescription narcotic means a narcotic that is contained in medication that may be prescribed verbally and that has the following characteristics:

          • (a) it contains two or more medicinal ingredients that are not narcotics, in a recognized therapeutic dose;

          • (b) it is not intended for parenteral administration; and

          • (c) it does not contain diacetylmorphine (heroin), hydrocodone, methadone, oxycodone or pentazocine. (stupéfiant d’ordonnance verbale)

        • Exception

          (2) Despite subitem 2(2) of the schedule, the following are not narcotics for the purposes of these Regulations:

          • (a) a drug in dosage form, as defined in subsection C.01.005(3) of the Food and Drug Regulations, that contains cocaine (benzoylmethylecgonine) or any of its salts unless the drug

            • (i) has a drug identification number assigned to it under Division 1 of Part C of those Regulations,

            • (ii) is authorized for sale under Division 5 of Part C of those Regulations, or

            • (iii) is compounded by a pharmacist in accordance with or in anticipation of an authorization from a practitioner that a stated amount of the drug be dispensed for a person who is or will be named in the authorization; or

          • (b) cocaine (benzoylmethylecgonine) or any of its salts or any drug that is not in dosage form that contains such a substance, unless the cocaine, salt or drug is to be compounded by a pharmacist in accordance with or in anticipation of an authorization from a practitioner that a stated amount of the drug be dispensed for a person who is or will be named in the authorization.

      Possession

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

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

            • (i) a licensed dealer,

            • (ii) a pharmacist, or

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

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

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

          • (d) has obtained the narcotic for their own use

            • (i) from a practitioner,

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

            • (iii) from a pharmacist under section 36;

          • (e) is a practitioner of medicine who received the narcotic under subsection 68(1) or (2) and their possession is for the purpose of providing or delivering it to a person referred to in subsection 68(3);

          • (f) is an agent or mandatary of a practitioner of medicine who received the narcotic under subsection 68(1) and their possession is for the purpose of providing or delivering it to a person referred to in subsection 68(2);

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

          • (h) is not a practitioner of medicine referred to in paragraph (e) or an agent or mandatary referred to in paragraph (f), is exempted under section 56 of the Act with respect to the possession of that narcotic and their possession is for a purpose set out in the exemption; or

          • (i) is the Minister.

        • Agent or mandatary

          (2) A person is authorized to possess a narcotic if the person is acting as the agent or mandatary of any person who is authorized to possess it in accordance with any of paragraphs (1)(a) to (e), (h) and (i).

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

          (3) A person is authorized to possess a narcotic if

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

          • (b) their possession of the narcotic is for the purpose of assisting that person in the administration or enforcement of an Act or regulation.

      Test Kits

      • Authorized activities

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

        • (a) a registration number has been issued for the test kit under section 6 and has not been cancelled under section 7;

        • (b) the test kit bears, on its external surface,

          • (i) the manufacturer’s name,

          • (ii) the trade name or trademark, and

          • (iii) the registration number; and

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

      • Application for registration number
        • 5 (1) The manufacturer of a test kit may obtain a registration number for it by submitting to the Minister an application containing

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

          • (b) a detailed description of the narcotic and other substances, if any, contained in the test kit, including the qualitative and quantitative composition of each component; and

          • (c) a description of the proposed use of the test kit.

        • Signature and attestation

          (2) The application must

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

          • (b) include an attestation by that person that all of the information submitted in support of the application is correct and complete to the best of their knowledge.

        • Additional information or document

          (3) The applicant must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.

      • Issuance of registration number

        6 On completion of the review of the application for a registration number, the Minister must issue a registration number for the test kit, preceded by the letters “TK”, if the Minister determines that the test kit will only be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose and that it contains

        • (a) a narcotic and an adulterating or denaturing agent in such a manner, combination, quantity, proportion or concentration that the preparation or mixture has no significant drug abuse potential; or

        • (b) such small quantities or concentrations of a narcotic as to have no significant drug abuse potential.

      • Cancellation of registration number

        7 The Minister must cancel the registration number for a test kit if

        • (a) the test kit is removed from the market by the manufacturer;

        • (b) the Minister has reasonable grounds to believe that the test kit is used or is likely to be used for any purpose other than a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; or

        • (c) the Minister has reasonable grounds to believe that the cancellation is necessary to protect public health or safety, including to prevent a narcotic from being diverted to an illicit market or use.

      Licensed Dealers

      Authorized Activities

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

        • Qualified person in charge present

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

        • Permit — import and export

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

        • Possession for export

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

        • Opium poppy — production

          (5) A licensed dealer may cultivate, propagate or harvest opium poppy only for scientific purposes.

      Dealer’s Licences

      Preliminary Requirements
      • Eligible persons

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

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

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

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

      • Senior person in charge

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

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

        • Alternate qualified person in charge

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

        • Qualifications

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

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

          • (b) they

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

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

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

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

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

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

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

        • Exception

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

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

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

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

      • Ineligibility

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

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

          • (i) was convicted as an adult, or

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

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

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

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

      Issuance of Licence
      • Application
        • 10 (1) A person who intends to conduct an activity referred to in section 8 must obtain a dealer’s licence for each site at which they intend to conduct activities by submitting an application to the Minister that contains the following information:

          • (a) if the licence is requested by

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

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

            • (iii) the holder of a position described in paragraph 9(c), the applicant’s name and the title of the position;

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

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

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

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

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

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

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

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

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

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

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

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

            • (iii) the name of the narcotic in the product or compound,

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

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

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

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

            • (i) the name of the narcotic,

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

            • (iii) if it is to be produced for another licensed dealer under a custom order, the name, municipal address and licence number of the other licensed dealer;

          • (h) if the licence is requested for an activity that is not described in paragraph (f) or (g), the name of the narcotic for which the activity is to be conducted and the purpose of the activity;

          • (i) a detailed description of the security measures in place at the site, determined in accordance with the Security Directive; and

          • (j) a detailed description of the method for recording information that the applicant proposes to use for the purpose of section 28.

        • Documents

          (2) An application for a dealer’s licence must be accompanied by the following documents:

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

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

            • (ii) any document filed with the province in which its site is located that states its corporate name and any other name registered with the province under which the applicant intends to conduct the activities specified in its dealer’s licence or by which it intends to identify itself;

          • (b) individual declarations signed and dated by each of the proposed senior person in charge, and qualified person in charge and any proposed alternate qualified person in charge, attesting that the person is not ineligible for a reason specified in section 9.3;

          • (c) a document issued by a Canadian police force in relation to each person referred to in paragraph (b), indicating whether, during 10 years before the day on which the application is submitted, the person was convicted as specified in subparagraph 9.3(a)(i) or received a sentence as specified in subparagraph 9.3(a)(ii);

          • (d) if any of the persons referred to in paragraph (b) has ordinarily resided in a country other than Canada during the 10 years before the day on which the application is submitted, a document issued by a police force of that country indicating whether in that period that person was convicted as specified in subparagraph 9.3(b)(i) or received a sentence as specified in subparagraph 9.3(b)(ii);

          • (e) declaration, signed and dated by the proposed senior person in charge, attesting that the proposed qualified person in charge and any proposed alternate qualified person in charge have the knowledge and experience required under paragraphs 9.2(3)(c) and (d); and

          • (f) if the proposed qualified person in charge or any proposed alternate qualified person in charge does not meet the requirement of subparagraph 9.2(3)(b)(i), either

            • (i) a copy of the person’s diploma, certificate or credential referred to in subparagraph 9.2(3)(b)(ii) or (iii), or

            • (ii) a detailed description of the education, training and work experience that is required under paragraph 9.2(4)(c), together with supporting evidence, such as a copy of a course transcript or an attestation by the person who provided the training.

        • Signature and attestation

          (3) The application must

          • (a) be signed and dated by the proposed senior person in charge; and

          • (b) include an attestation by that person that

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

            • (ii) they have the authority to bind the applicant.

        • Additional information and documents

          (4) The applicant must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.

      • Issuance

        10.1 Subject to section 10.3, on completion of the review of the licence application, the Minister must issue a dealer’s licence, with or without terms and conditions, that contains

        • (a) the licence number;

        • (b) the name of the licensed dealer, their corporate name or the title of the position they hold;

        • (c) the activities that are authorized and the names of the narcotics in respect of which each activity may be conducted;

        • (d) the municipal address of the site at which the dealer may conduct the authorized activities;

        • (e) the security level at the site, determined in accordance with the Security Directive;

        • (f) the effective date of the licence;

        • (g) the expiry date of the licence, which must be not later than three years after its effective date;

        • (h) any terms and conditions that the Minister has reasonable grounds to believe are necessary to

          • (i) ensure that an international obligation is respected,

          • (ii) ensure conformity with the requirements associated with the security level that is referred to in paragraph (e), or

          • (iii) reduce a risk to public health or safety, including the risk of a narcotic being diverted to an illicit market or use; and

        • (i) if the licensed dealer produces a narcotic, the quantity that they may produce and the authorized production period.

      • Validity

        10.2 A dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section 16 or 17.

      • Refusal
        • 10.3 (1) The Minister must refuse to issue a dealer’s licence if

          • (a) the applicant may not apply for a licence under section 9;

          • (b) during the 10 years before the day on which the licence application is submitted, the applicant has contravened

            • (i) a provision of the Act, the Cannabis Act or their regulations, or

            • (ii) a term or condition of a licence or permit issued to the applicant under any regulations made under the Act or issued to the applicant under the Cannabis Act or its regulations;

          • (c) during the 10 years before the day on which the licence application is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph 9.3(a)(i) or (b)(i) or received a sentence as specified in subparagraph 9.3(a)(ii) or (b)(ii);

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

          • (e) an activity for which the licence is requested is the cultivation, propagation or harvesting of opium poppy other than for scientific purposes;

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

          • (g) the method referred to in paragraph 10(1)(j) does not permit the recording of information as required by section 28;

          • (h) the applicant has not complied with the requirements of subsection 10(4) or the information or documents that they have provided are not sufficient to complete the review of the licence application;

          • (i) the Minister has reasonable grounds to believe that the applicant has submitted false or misleading information or false or falsified documents in or in support of the licence application;

          • (j) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the applicant has been involved in the diversion of a narcotic to an illicit market or use or has been involved in an activity that contravened an international obligation; or

          • (k) the Minister has reasonable grounds to believe that the issuance of the licence would likely create a risk to public health or safety, including the risk of a narcotic being diverted to an illicit market or use.

        • Exceptions

          (2) The Minister must not refuse to issue a licence under paragraph (1)(b) or (i) if the applicant meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a narcotic from being diverted to an illicit market or use:

          • (a) the applicant does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and

          • (b) the applicant has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations.

        • Notice

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

      Renewal of Licence
      • Application
        • 11 (1) To apply to renew a dealer’s licence, a licensed dealer must submit to the Minister an application that contains the information and documents referred to in subsections 10(1) and (2).

        • Signature and attestation

          (2) The application must

          • (a) be signed and dated by the senior person in charge of the site specified in the application; and

          • (b) include an attestation by that person that

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

            • (ii) they have the authority to bind the licensed dealer.

        • Additional information and documents

          (3) The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.

      • Renewal
        • 11.1 (1) Subject to section 11.3, on completion of the review of the renewal application, the Minister must issue a renewed dealer’s licence that contains the information specified in section 10.1.

        • Terms and conditions

          (2) When renewing a dealer’s licence, the Minister may, if he or she has reasonable grounds to believe that it is necessary to do so, add a term or condition to it or modify or delete one in order to

          • (a) ensure that an international obligation is respected;

          • (b) ensure conformity with the requirements associated with the security level specified in the licence or the new level required as a result of the licence renewal; or

          • (c) reduce a risk to public health or safety, including the risk of a narcotic being diverted to an illicit market or use.

      • Validity

        11.2 A renewed dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section 16 or 17.

      • Refusal
        • 11.3 (1) The Minister must refuse to renew a dealer’s licence if

          • (a) the licensed dealer may no longer apply for a licence under section 9;

          • (b) during the 10 years before the day on which the renewal application is submitted, the licensed dealer has contravened

            • (i) a provision of the Act, the Cannabis Act or their Regulations, or

            • (ii) a term or condition of a licence or permit issued to the dealer under a regulation made under the Act or issued to the dealer under the Cannabis Act or its regulations;

          • (c) during the 10 years before the day on which the renewal application is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph 9.3(a)(i) or (b)(i) or received a sentence as specified in subparagraph 9.3(a)(ii) or (b)(ii);

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

          • (e) an activity for which the licence is requested is the cultivation, propagation or harvesting of opium poppy other than for scientific purposes;

          • (f) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the renewal is requested;

          • (g) the method referred to in paragraph 10(1)(j) does not permit the recording of information as required by section 28;

          • (h) the licensed dealer has not complied with the requirements of subsection 11(3) or the information or documents that they have provided are not sufficient to complete the review of the renewal application;

          • (i) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the renewal application;

          • (j) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a narcotic to an illicit market or use or has been involved in an activity that contravened an international obligation; or

          • (k) the Minister has reasonable grounds to believe that the renewal of the licence would likely create a risk to public health or safety, including the risk of a narcotic being diverted to an illicit market or use.

        • Exceptions

          (2) The Minister must not refuse to renew a licence under paragraph (1)(b) or (i) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a narcotic from being diverted to an illicit market or use:

          • (a) the licensed dealer does not have a history of non-compliance with the Act or the Cannabis Act or their regulations; and

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

        • Notice

          (3) Before refusing to renew a licence, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

      Amendment of Licence
      • Application
        • 12 (1) Before making a change affecting any information referred to in section 10.1 that is contained in their dealer’s licence, a licensed dealer must submit to the Minister an application to amend the licence that contains a description of the proposed amendment, as well as the information and documents referred to in section 10 that are relevant to the proposed amendment.

        • Signature and attestation

          (2) The application must

          • (a) be signed and dated by the senior person in charge of the site specified in the application; and

          • (b) include an attestation by that person that

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

            • (ii) they have the authority to bind the licensed dealer.

        • Additional information and documents

          (3) The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.

      • Amendment
        • 12.1 (1) Subject to section 12.3, on completion of the review of the amendment application, the Minister must amend the dealer’s licence.

        • Terms and conditions

          (2) When amending a dealer’s licence, the Minister may, if he or she has reasonable grounds to believe that it is necessary to do so, add a term or condition to it or modify or delete one in order to

          • (a) ensure that an international obligation is respected;

          • (b) ensure conformity with the requirements associated with the security level specified in the licence or the new level required as a result of the amendment; or

          • (c) reduce a risk to public health or safety, including the risk of a narcotic being diverted to an illicit market or use.

      • Validity

        12.2 An amended dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section 16 or 17.

      • Refusal
        • 12.3 (1) The Minister must refuse to amend a dealer’s licence if

          • (a) an activity for which the amendment is requested would contravene an international obligation;

          • (b) an activity for which the licence is requested is the cultivation, propagation or harvesting of opium poppy other than for scientific purposes;

          • (c) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the amendment is requested;

          • (d) the method referred to in paragraph 10(1)(j) does not permit the recording of information as required by section 28;

          • (e) the licensed dealer has not complied with the requirements of subsection 12(3) or the information or documents that they have provided are not sufficient to complete the review of the amendment application;

          • (f) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the amendment application; or

          • (g) the Minister has reasonable grounds to believe that the amendment of the licence would likely create a risk to public health or safety, including the risk of a narcotic being diverted to an illicit market or use.

        • Exceptions

          (2) The Minister must not refuse to amend a licence under paragraph (1)(f) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a narcotic from being diverted to an illicit market or use:

          • (a) the licensed dealer does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and

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

        • Notice

          (3) Before refusing to amend a licence, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

      Changes Requiring Prior Approval by Minister
      • Application
        • 13 (1) A licensed dealer must obtain the Minister’s approval before making any of the following changes by submitting a written application to the Minister:

          • (a) a change affecting the security measures in place at the site specified in the dealer’s licence;

          • (b) the replacement of the senior person in charge;

          • (c) the replacement of the qualified person in charge; or

          • (d) the replacement or addition of an alternate qualified person in charge.

        • Information and documents

          (2) The licensed dealer must provide the Minister with the following with respect to a change referred to in subsection (1):

          • (a) in the case of a change affecting the security measures in place at the site specified in the dealer’s licence, details of the change;

          • (b) in the case of the senior person in charge,

            • (i) the information specified in paragraph 10(1)(c), and

            • (ii) the declaration specified in paragraph 10(2)(b) and the documents specified in paragraphs 10(2)(c) and (d); and

          • (c) in the case of the qualified person in charge or an alternate qualified person in charge,

            • (i) the information specified in paragraph 10(1)(d), and

            • (ii) the declarations specified in paragraphs 10(2)(b) and (e) and the documents specified in paragraphs 10(2)(c), (d) and (f).

        • Additional information and documents

          (3) The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.

      • Approval
        • 13.1 (1) Subject to section 13.2, on completion of the review of the application for approval of the change, the Minister must approve the change.

        • Terms and conditions

          (2) When approving a change, the Minister may, if he or she has reasonable grounds to believe that it is necessary to do so, add a term or condition to the licence or modify or delete one in order to

          • (a) ensure that an international obligation is respected;

          • (b) ensure conformity with the requirements associated with the security level specified in the licence; or

          • (c) reduce a risk to public health or safety, including the risk of a narcotic being diverted to an illicit market or use.

      • Refusal
        • 13.2 (1) The Minister must refuse to approve the change if

          • (a) during the 10 years before the day on which the application for approval of the change is submitted, the proposed senior person in charge or qualified person in charge or any proposed alternate qualified person in charge was convicted as specified in subparagraph 9.3(a)(i) or (b)(i) or received a sentence as specified in subparagraph 9.3(a)(ii) or (b)(ii);

          • (b) the licensed dealer has not complied with the requirements of subsection 13(3) or the information or documents that they have provided are not sufficient to complete the review of the application for approval of the change;

          • (c) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the application for approval of the change; or

          • (d) the Minister has reasonable grounds to believe that the change would likely create a risk to public health or safety, including the risk of a narcotic being diverted to an illicit market or use.

        • Exceptions

          (2) The Minister must not refuse to approve a change under paragraph (1)(c) if the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act and their regulations, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a narcotic from being diverted to an illicit market or use.

        • Notice

          (3) Before refusing to approve a change, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard in respect of them.

      Changes Requiring Notice to Minister
      • Prior notice
        • 14 (1) A licensed dealer must notify the Minister in writing before

          • (a) manufacturing or assembling a product or compound that is not set out in the most recent version of the list referred to in paragraph 10(1)(f) that has been submitted to the Minister; or

          • (b) making a change to a product or compound that is set out in the list, if the change affects any of the information that has previously been submitted.

        • Information and list

          (2) The notice must contain the information referred to in paragraph 10(1)(f) that is necessary to update the list and be accompanied by the revised version of the list.

      • Notice — five days

        14.1 A licensed dealer must notify the Minister in writing within five days after a person ceases to act as the qualified person in charge or an alternate qualified person in charge.

      • Notice — 10 days
        • 14.2 (1) A licensed dealer must notify the Minister in writing within 10 days after one of the following changes occurs:

          • (a) a person ceases to act as the senior person in charge; or

          • (b) the licensed dealer ceases to manufacture or assemble a product or compound that is set out in the most recent version of the list referred to in paragraph 10(1)(f) that has been submitted to the Minister.

        • Information and list

          (2) A notice submitted under paragraph (1)(b) must specify which information referred to in paragraph 10(1)(f) is being changed and be accompanied by the revised version of the list.

      • Notice of cessation of activities
        • 14.3 (1) A licensed dealer that intends to cease conducting activities at their site — whether on or before the expiry of their licence — must notify the Minister in writing to that effect at least 30 days before ceasing those activities.

        • Content of notice

          (2) The notice must be signed and dated by the senior person in charge and contain the following information:

          • (a) the expected date of the cessation of activities at the site;

          • (b) a description of the manner in which any remaining narcotics on the site as of that date will be disposed of by the licensed dealer, including

            • (i) if some or all of them will be sold or provided to another licensed dealer that will be conducting activities at the same site, the name of that dealer,

            • (ii) if some or all of them will be sold or provided to another licensed dealer that will not be conducting activities at the same site, the name of that dealer and the municipal address of their site, and

            • (iii) if some or all of them will be destroyed, the date on which and the municipal address of the location at which the destruction is to take place;

          • (c) the municipal address of the location at which the licensed dealer’s documents will be kept after activities have ceased; and

          • (d) the name, municipal address, telephone number and, if applicable, the email address of a person who the Minister may contact for further information after activities have ceased.

        • Update

          (3) After having ceased to conduct the activities, the licensed dealer must submit to the Minister a detailed update of the information referred to in subsection (2) if it differs from what was set out in the notice. The update must be signed and dated by the senior person in charge.

      Changes to Terms and Conditions of Licence
      • Addition of or modification to term or condition
        • 15 (1) The Minister may, at any time other than at the issuance, renewal or amendment of a dealer’s licence, add a term or condition to it or modify one if the Minister has reasonable grounds to believe that it is necessary to do so to

          • (a) ensure that an international obligation is respected;

          • (b) ensure conformity with the requirements associated with the security level specified in the licence; or

          • (c) reduce a risk to public health or safety, including the risk of a narcotic being diverted to an illicit market or use.

        • Notice

          (2) Before adding a term or condition to a licence or modifying one, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

        • Urgent circumstances

          (3) Despite subsection (2), the Minister may add a term or condition to a licence or modify one without prior notice if the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a narcotic from being diverted to an illicit market or use.

        • Urgent circumstances — notice

          (4) The addition or modification of a term or condition that is made under subsection (3) takes effect as soon as the Minister sends the licensed dealer a notice that

          • (a) sets out the reasons for the addition or modification;

          • (b) gives the dealer an opportunity to be heard; and

          • (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

      • Deletion of term or condition
        • 15.1 (1) The Minister may delete a term or condition of a dealer’s licence that the Minister determines is no longer necessary.

        • Notice

          (2) The deletion takes effect as soon as the Minister sends the licensed dealer a notice to that effect.

      Suspension and Revocation of Licence
      • Suspension
        • 16 (1) The Minister must suspend a dealer’s licence without prior notice if the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a narcotic from being diverted to an illicit market or use.

        • Notice

          (2) The suspension takes effect as soon as the Minister sends the licensed dealer a notice that

          • (a) sets out the reasons for the suspension;

          • (b) gives the dealer an opportunity to be heard; and

          • (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

        • Reinstatement of licence

          (3) The Minister must reinstate the licence if the Minister has reasonable grounds to believe that the suspension is no longer necessary.

      • Revocation
        • 17 (1) Subject to subsection (2), the Minister must revoke a dealer’s licence if

          • (a) the licensed dealer is no longer eligible to apply for a licence under section 9;

          • (b) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the licence or the actual or potential unauthorized use of the licence;

          • (c) the licensed dealer ceases to conduct activities at their site before the expiry of their licence;

          • (d) the licensed dealer does not take the corrective measures specified in an undertaking or notice;

          • (e) the licensed dealer has contravened

            • (i) a provision of the Act, the Cannabis Act or their regulations, or

            • (ii) a term or condition of a licence or permit issued to the dealer under a regulation made under the Act or issued to the dealer under the Cannabis Act or its regulations;

          • (f) during the 10 years before the day on which the application is submitted, the senior person in charge, the qualified person in charge or any alternate qualified person in charge was convicted as specified in subparagraph 9.3(a)(i) or (b)(i) or received a sentence as specified in subparagraph 9.3(a)(ii) or (b)(ii);

          • (g) the Minister has reasonable grounds to believe that the licensed dealer submitted false or misleading information or false or falsified documents in or in support of an application relating to the licence; or

          • (h) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a narcotic to an illicit market or use.

        • Exceptions

          (2) The Minister must not revoke a dealer’s licence for a ground set out in paragraph (1)(e) or (g) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a narcotic from being diverted to an illicit market or use:

          • (a) the licensed dealer does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and

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

        • Notice

          (3) Before revoking a licence, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

      • Return of licence

        17.1 The licensed dealer must return the original of the licence to the Minister within 15 days after the effective date of the revocation.

      Import Permits

      • Application
        • 18 (1) A licensed dealer must submit to the Minister, before each importation of a narcotic, an application for an import permit that contains the following information:

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

          • (b) with respect to the narcotic to be imported,

            • (i) its name, as specified in the dealer’s licence,

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

            • (iii) its quantity, and

            • (iv) in the case of a raw material, its purity and its anhydrous content;

          • (c) if the narcotic is contained in a product to be imported,

            • (i) the brand name of the product,

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

            • (iii) the strength per unit of the narcotic in the product, the number of units per package and the number of packages;

          • (d) the name and municipal address of the exporter in the country of export from whom the narcotic is being obtained;

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

          • (f) each proposed mode of transportation and any proposed country of transit or transhipment.

        • Signature and attestation

          (2) The application must

          • (a) be signed and dated by the qualified person in charge or an alternate qualified person in charge; and

          • (b) include an attestation by that person that all of the information submitted in support of the application is correct and complete to the best of their knowledge.

        • Additional information and documents

          (3) The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.

      • Issuance

        18.1 Subject to section 18.4, on completion of the review of the import permit application, the Minister must issue to the licensed dealer an import permit that contains

        • (a) the permit number;

        • (b) the information set out in subsection 18(1);

        • (c) the effective date of the permit;

        • (d) the expiry date of the permit, being the earlier of

          • (i) a date specified by the Minister that is not more than 180 days after its effective date, and

          • (ii) the expiry date of the dealer’s licence; and

        • (e) any terms and conditions that the Minister has reasonable grounds to believe are necessary to

          • (i) ensure that an international obligation is respected, or

          • (ii) reduce a risk to public health or safety, including the risk of a narcotic being diverted to an illicit market or use.

      • Validity

        18.2 An import permit is valid until the earliest of

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

        • (b) the date of the suspension or revocation of the permit under section 19 or 20,

        • (c) the date of the suspension or revocation of the dealer’s licence under section 16 or 17, and

        • (d) the date of the suspension or revocation of the export permit that applies to the narcotic to be imported and that is issued by the competent authority in the country of export.

      • Return of permit

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

      • Refusal
        • 18.4 (1) The Minister must refuse to issue an import permit if

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

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

          • (c) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of the importation;

          • (d) the licensed dealer has not complied with the requirements of subsection 18(3) or the information or documents that they have provided are not sufficient to complete the review of the permit application;

          • (e) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the permit application;

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

          • (g) the Minister has reasonable grounds to believe that the importation would contravene the laws of the country of export or any country of transit or transhipment; or

          • (h) the Minister has reasonable grounds to believe that the issuance of the permit would likely create a risk to public health or safety, including the risk of a narcotic being diverted to an illicit market or use.

        • Notice

          (2) Before refusing to issue the import permit, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

      • Providing copy of permit

        18.5 The holder of an import permit must provide a copy of the permit to the customs office at the time of importation.

      • Declaration

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

        • (a) their name and the numbers of their dealer’s licence and the import permit that applies to the narcotic;

        • (b) with respect to the narcotic,

          • (i) its name, as set out in the dealer’s licence,

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

          • (iii) its quantity;

        • (c) if the narcotic is contained in a product that they have imported,

          • (i) the brand name of the product,

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

          • (iii) the strength per unit of the narcotic in the product, the number of units per package and the number of packages; and

        • (d) the name of the customs office from which the narcotic was released and the date of the release.

      • Suspension
        • 19 (1) The Minister must suspend an import permit without prior notice if

          • (a) the dealer’s licence is suspended;

          • (b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health or safety, including to prevent a narcotic from being diverted to an illicit market or use; or

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

        • Notice

          (2) The suspension takes effect as soon as the Minister sends the licensed dealer a notice that

          • (a) sets out the reasons for the suspension;

          • (b) gives the dealer an opportunity to be heard; and

          • (c) if applicable, specifies the corrective measures that must be carried out and the date by which they must be carried out.

        • Reinstatement of permit

          (3) The Minister must reinstate the import permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary.

      • Revocation
        • 20 (1) Subject to subsection (2), the Minister must revoke an import permit if

          • (a) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the permit or the actual or potential unauthorized use of the permit;

          • (b) the licensed dealer does not carry out the corrective measures specified by the Minister under paragraph 19(2)(c) by the specified date;

          • (c) the licensed dealer has contravened a term or condition of the permit;

          • (d) the Minister has reasonable grounds to believe that the licensed dealer submitted false or misleading information or false or falsified documents in or in support of the application for the permit;

          • (e) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a narcotic to an illicit market or use; or

          • (f) the dealer’s licence has been revoked.

        • Exceptions

          (2) The Minister must not revoke an import permit for a ground set out in paragraph (1)(d) or 17(1)(e) or (g) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a narcotic from being diverted to an illicit market or use:

          • (a) the licensed dealer does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and

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

        • Notice

          (3) Before revoking an import permit, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

      • Return of permit

        20.1 If an import permit is revoked, the licensed dealer must return the original of the permit to the Minister within 15 days after the effective date of the revocation.

      Export Permits

      • Application
        • 21 (1) A licensed dealer must submit to the Minister, before each exportation of a narcotic, an application for an export permit that contains the following information and document:

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

          • (b) with respect to the narcotic to be exported,

            • (i) its name, as specified in the dealer’s licence,

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

            • (iii) its quantity, and

            • (iv) in the case of a raw material, its purity and its anhydrous content;

          • (c) in the case of the exportation of a product that contains the narcotic,

            • (i) the brand name of the product,

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

            • (iii) the strength per unit of the narcotic in the product, the number of units per package and the number of packages;

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

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

          • (f) each proposed mode of transportation to be used and any proposed country of transit or transhipment; and

          • (g) a copy of the import permit issued by the competent authority in the country of final destination that sets out the name of the importer and the municipal address of their site in that country.

        • Signature and attestation

          (2) The application must

          • (a) be signed and dated by the qualified person in charge or an alternate qualified person in charge; and

          • (b) include an attestation by that person that, to the best of their knowledge,

            • (i) the exportation does not contravene any requirement of the laws of the country of final destination or any country of transit or transhipment, and

            • (ii) all of the information and documents submitted in support of the application are correct and complete.

        • Additional information and documents

          (3) The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.

      • Issuance

        21.1 Subject to section 21.4, on completion of the review of the export permit application, the Minister must issue to the licensed dealer an export permit that contains

        • (a) the permit number;

        • (b) the information set out in paragraphs 21(1)(a) to (f);

        • (c) the effective date of the permit;

        • (d) the expiry date of the permit, being the earliest of

          • (i) a date specified by the Minister that is not more than 180 days after its effective date,

          • (ii) the expiry date of the dealer’s licence, and

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

        • (e) any terms and conditions that the Minister has reasonable grounds to believe are necessary to

          • (i) ensure that an international obligation is respected, or

          • (ii) reduce a risk to public health or safety, including the risk of a narcotic being diverted to an illicit market or use.

      • Validity

        21.2 An export permit is valid until the earliest of

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

        • (b) the date of the suspension or revocation of the permit under section 22 or 23,

        • (c) the date of the suspension or revocation of the dealer’s licence under section 16 or 17, and

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

      • Return of permit

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

      • Refusal
        • 21.4 (1) The Minister must refuse to issue an export permit if

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

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

          • (c) the licensed dealer has not complied with the requirements of subsection 21(3) or the information or documents that they have provided are not sufficient to complete the review of the permit application;

          • (d) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the permit application;

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

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

          • (g) the Minister has reasonable grounds to believe that the exportation would contravene the laws of the country of final destination or any country of transit or transhipment; or

          • (h) the Minister has reasonable grounds to believe that the issuance of the permit would likely create a risk to public health or safety, including the risk of a narcotic being diverted to an illicit market or use.

        • Notice

          (2) Before refusing to issue the export permit, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

      • Providing copy of permit

        21.5 The holder of an export permit must provide a copy of the permit to the customs office at the time of exportation.

      • Declaration

        21.6 The holder of an export permit must provide the Minister, within 15 days after the day of export of the narcotic specified in the permit, with a declaration that contains the following information:

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

        • (b) with respect to the narcotic,

          • (i) its name, as specified in the dealer’s licence,

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

          • (iii) its quantity;

        • (c) if the narcotic is contained in a product that they have exported,

          • (i) the brand name of the product,

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

          • (iii) the strength per unit of the narcotic in the product, the number of units per package and the number of packages; and

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

      • Suspension
        • 22 (1) The Minister must suspend an export permit without prior notice if

          • (a) the dealer’s licence is suspended;

          • (b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health or safety, including to prevent a narcotic from being diverted to an illicit market or use; or

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

        • Notice

          (2) The suspension takes effect as soon as the Minister sends the licensed dealer a notice that

          • (a) sets out the reasons for the suspension;

          • (b) gives the dealer an opportunity to be heard; and

          • (c) if applicable, specifies the corrective measures that must be carried out by the dealer and the date by which the dealer must do so.

        • Reinstatement of permit

          (3) The Minister must reinstate the export permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary.

      • Revocation
        • 23 (1) Subject to subsection (2), the Minister must revoke an export permit if

          • (a) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the permit or the actual or potential unauthorized use of the permit;

          • (b) the licensed dealer does not carry out the corrective measures specified by the Minister under paragraph 22(2)(c) by the specified date;

          • (c) the licensed dealer has contravened a term or condition of the permit;

          • (d) the Minister has reasonable grounds to believe that the licensed dealer submitted false or misleading information or false or falsified documents in or in support of the application for the permit;

          • (e) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a narcotic to an illicit market or use; or

          • (f) the dealer’s licence has been revoked.

        • Exceptions

          (2) The Minister must not revoke an export permit for a ground set out in paragraph (1)(d) or 17(1)(e) or (g) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including to prevent a narcotic from being diverted to an illicit market or use:

          • (a) the licensed dealer does not have a history of non-compliance with the Act, the Cannabis Act or their regulations; and

          • (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act, the Cannabis Act or their regulations.

        • Notice

          (3) Before revoking an export permit, the Minister must send the licensed dealer a notice that sets out the Minister’s reasons and gives the dealer an opportunity to be heard.

      • Return of permit

        23.1 If an export permit is revoked, the licensed dealer must return the original of the permit to the Minister within 15 days after the effective date of the revocation.

      Identification

      • Name

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

      Sale of Narcotics

      • Sale to another licensed dealer

        25 A licensed dealer may sell or provide a narcotic to another licensed dealer.

      • Sale to pharmacist
        • 25.1 (1) Subject to subsection (2), a licensed dealer may sell or provide a narcotic to a pharmacist.

        • Exception — pharmacist named in notice

          (2) A licensed dealer must not sell or provide to a pharmacist who is named in a notice issued under subsection 48(1) the narcotics referred to in the notice.

        • Retraction

          (3) Subsection (2) does not apply to a licensed dealer that has received a notice of retraction issued under section 49 in respect of a pharmacist named in a notice issued under subsection 48(1).

      • Sale to practitioner
        • 25.2 (1) Subject to subsections (2) and (3), a licensed dealer may sell or provide to a practitioner a narcotic other than diacetylmorphine (heroin).

        • Exception — heroin

          (2) A licensed dealer may sell or provide diacetylmorphine (heroin) to the following practitioners:

          • (a) a practitioner of medicine;

          • (b) a practitioner of dentistry, if practising in a hospital that provides care or treatment to persons; or

          • (c) a nurse practitioner.

        • Exception — practitioner named in notice

          (3) A licensed dealer must not sell or provide to a practitioner who is named in a notice issued under subsection 59(1) the narcotics referred to in the notice unless the dealer has received a notice of retraction issued under section 60.

      • Provision to hospital employee
        • 25.3 (1) Subject to subsection (2), a licensed dealer may provide a narcotic to a hospital employee.

        • Exception — heroin

          (2) A licensed dealer may provide diacetylmorphine (heroin) to a hospital employee only if that hospital provides care or treatment to persons.

      • Sale to exempted person

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

      • Sale to Minister

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

      • Written order

        25.6 A licensed dealer may sell or provide a narcotic under any of sections 25 to 25.5 if

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

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

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

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

      • Verbal order
        • 25.7 (1) A licensed dealer may sell or provide a verbal prescription narcotic under sections 25 to 25.5 if

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

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

        • Receipt

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

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

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

          • (c) the name and quantity of the narcotic.

        • No further sale without receipt

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

      Packaging and Transportation

      • Packaging — sale and provision
        • 26 (1) A licensed dealer that sells or provides a narcotic, other than a preparation described in section 36, must securely package it in its immediate container, which must be sealed in such a manner that the container cannot be opened without breaking the seal.

        • Packaging — transport and export

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

        • Exception

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

      • Transport
        • 26.1 (1) A licensed dealer must, in taking delivery of a narcotic that they have imported or in making delivery of a narcotic,

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

          • (b) subject to subsection (2), use a method of transportation that permits an accurate record to be kept of all handling of the narcotic as well as of the signatures of every person handling the narcotic until it is delivered to the consignee;

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

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

        • Exception

          (2) A licensed dealer may have a verbal prescription narcotic transported by a common carrier.

      Thefts, Losses and Suspicious Transactions

      • Protective measures

        27 A licensed dealer must take any measures that are necessary to ensure the security of any narcotic in their possession and any licence or permit in their possession.

      • Theft or loss — licences and permits

        27.1 A licensed dealer that becomes aware of a theft or loss of their licence or permit must provide a written report to the Minister within 72 hours after becoming aware of it.

      • Theft or unexplainable loss — narcotics

        27.2 A licensed dealer that becomes aware of a theft of a narcotic or of a loss of a narcotic that cannot be explained on the basis of normally accepted business activities must

        • (a) provide a written report to a member of a police force within 24 hours after becoming aware of the theft or loss; and

        • (b) provide a written report to the Minister within 72 hours after becoming aware of the theft or loss and include a confirmation that the report required under paragraph (a) has been provided.

      • Suspicious transaction
        • 27.3 (1) A licensed dealer must provide a written report containing the following information to the Minister within 72 hours after becoming aware of a transaction occurring in the course of their activities that they have reasonable grounds to suspect may be related to the diversion of a narcotic to an illicit market or use:

          • (a) their name, municipal address, telephone number and, if the licensed dealer is a corporation, the position held by the individual making the report;

          • (b) the name and municipal address of the other party to the transaction;

          • (c) details of the transaction, including its date and time, its type, the name and quantity of the narcotic and, in the case of a product or compound, the quantity of every narcotic that it contains;

          • (d) in the case of a product that contains the narcotic, other than a test kit, the drug identification number that is assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any; and

          • (e) a detailed description of the reasons for those suspicions.

        • Good faith

          (2) No civil proceedings lie against a licensed dealer for having provided the report in good faith.

        • Non-disclosure

          (3) A licensed dealer must not disclose that they have provided the report or disclose details of it, with the intent to prejudice a criminal investigation, whether or not a criminal investigation has begun.

      • Partial protection against self-incrimination

        27.4 A report made under any of sections 27.1 to 27.3, or any evidence derived from it, is not to be used or received to incriminate the licensed dealer in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

      Destruction of Narcotics

      • Destruction at site

        27.5 A licensed dealer that intends to destroy a narcotic at the site specified in their licence must ensure that the following conditions are met:

        • (a) the licensed dealer obtains the prior approval of the Minister;

        • (b) the destruction is carried out in the presence of two of the following persons, at least one of whom must be a person referred to in subparagraph (i):

          • (i) the senior person in charge, the qualified person in charge or an alternate qualified person in charge, and

          • (ii) a person who works for or provides services to the licensed dealer and holds a senior position;

        • (c) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and

        • (d) as soon as the destruction is completed, the person who carried out the destruction and each of the two persons referred to in paragraph (b) who were present at the destruction sign and date a joint declaration attesting that the narcotic was completely destroyed, to which each signatory must add their name in printed letters.

      • Destruction elsewhere than at site

        27.6 A licensed dealer that intends to destroy a narcotic elsewhere than at the site specified in their licence must ensure that the following conditions are met:

        • (a) the licensed dealer obtains the prior approval of the Minister;

        • (b) the licensed dealer takes any measures that are necessary to ensure the security of the narcotic while it is being transported in order to prevent its diversion to an illicit market or use;

        • (c) the destruction is carried out by a person working for a business that specializes in the destruction of dangerous goods and in the presence of another person working for that business;

        • (d) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and

        • (e) as soon as the destruction is completed, the person who carried out the destruction provides the licensed dealer with a dated declaration attesting that the narcotic was completely destroyed and containing

          • (i) the municipal address of the place of destruction,

          • (ii) the name and quantity of the narcotic and, if applicable, the brand name and quantity of the product containing it or the name and quantity of the compound containing it,

          • (iii) the method of destruction,

          • (iv) the date of destruction, and

          • (v) the names in printed letters and signatures of that person and the other person who was present at the destruction.

      • Application for prior approval
        • 27.7 (1) A licensed dealer must submit to the Minister an application that contains the following information in order to obtain the Minister’s prior approval to destroy a narcotic:

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

          • (b) the proposed date of destruction;

          • (c) the municipal address of the place of destruction;

          • (d) a brief description of the method of destruction;

          • (e) if the destruction is to be carried out at the site specified in the dealer’s licence, the names of the persons proposed for the purpose of paragraph 27.5(b) and information establishing that they meet the conditions of that paragraph;

          • (f) the name of the narcotic and, if applicable, the brand name of the product containing it or the name of the compound containing it; and

          • (g) the form and quantity of the narcotic or the product or compound containing it and, if applicable, the strength per unit of the narcotic in the product or compound, the number of units per package and the number of packages.

        • Signature and attestation

          (2) The application must

          • (a) be signed and dated by the qualified person in charge or an alternate qualified person in charge; and

          • (b) include an attestation by that person that

            • (i) the proposed method of destruction complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction, and

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

        • Additional information and documents

          (3) The licensed dealer must, not later than the date specified in the Minister’s written request to that effect, provide the Minister with any information or document that the Minister determines is necessary to complete the review of the application.

      • Approval

        27.8 On completion of the review of the approval application, the Minister must approve the destruction of the narcotic unless

        • (a) in the case of a destruction that is to be carried out at the site specified in the dealer’s licence, the persons proposed for the purpose of paragraph 27.5(b) do not meet the conditions of that paragraph;

        • (b) the Minister has reasonable grounds to believe that the narcotic would not be destroyed;

        • (c) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or in support of the approval application;

        • (d) the narcotic or a portion of it is required for the purposes of a criminal or administrative investigation or a preliminary inquiry, trial or other proceeding under any Act or its regulations; or

        • (e) the Minister has reasonable grounds to believe that the approval would likely create a risk to public health or safety, including the risk of the narcotic being diverted to an illicit market or use.

      Documents

      • Method of recording information

        28 A licensed dealer must record any information that they are required to record under these Regulations using a method that permits an audit of it to be made at any time.

      • Information — general

        28.1 A licensed dealer must record the following information:

        • (a) the name, form and quantity of any narcotic that the dealer orders, the name of the person who placed the order on the dealer’s behalf and the date of the order;

        • (b) the name, form and quantity of any narcotic that the dealer receives, the name and municipal address of the person who sold or provided it and the date on which it was received;

        • (c) in the case of a narcotic that the dealer sells or provides,

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

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

          • (iii) the form and quantity of the narcotic and, if applicable, the strength per unit of the narcotic in the product or compound, the number of units per package and the number of packages,

          • (iv) the name and municipal address of the person to whom it was sold or provided, and

          • (v) the date on which it was sold or provided;

        • (d) the name, form and quantity of any narcotic that the dealer manufactures or assembles and the date on which it was placed in stock and, if applicable, the strength per unit of the narcotic in the product or compound, the number of units per package and the number of packages;

        • (e) the name and quantity of any narcotic that the dealer uses in the manufacturing or assembling of a product or compound, as well as the brand name and quantity of the product or the name and quantity of the compound, and the date on which the product or compound was placed in stock;

        • (f) the name, form and quantity of any narcotic in stock at the end of each month;

        • (g) the name, form and quantity of any narcotic that the dealer delivers, transports or sends, the name and municipal address of the consignee and the date on which it was delivered, transported or sent;

        • (h) the name, form and quantity of any narcotic that the dealer imports, the date on which it was imported, the name and municipal address of the exporter, the country of exportation and any country of transit or transhipment; and

        • (i) the name, form and quantity of any narcotic that the dealer exports, the date on which it was exported, the name and municipal address of the importer, the country of final destination and any country of transit or transhipment.

      • Verbal prescription narcotic

        28.2 A licensed dealer that receives a verbal order for a verbal prescription narcotic and sells or provides it to a pharmacist, a practitioner or a hospital employee must immediately record

        • (a) the name of the person who placed the order;

        • (b) the date on which the order was received; and

        • (c) the name of the person recording the order.

      • Explainable loss of narcotic

        28.3 A licensed dealer that becomes aware of a loss of a narcotic that can be explained on the basis of normally accepted business activities must record the following information:

        • (a) the name of the lost narcotic and, if applicable, the brand name of the product or the name of the compound containing it;

        • (b) the form and quantity of the narcotic and, if applicable, the form of the product or compound containing it, the strength per unit of the narcotic in the product or compound, the number of units per package and the number of packages;

        • (c) the date on which the dealer became aware of the loss; and

        • (d) the explanation for the loss.

      • Destruction

        28.4 A licensed dealer must record the following information concerning any narcotic that they destroy at the site specified in their licence:

        • (a) the municipal address of the place of destruction;

        • (b) the name, form and quantity of the narcotic and, if applicable, the brand name and quantity of the product containing the narcotic or the name and quantity of the compound containing the narcotic;

        • (c) the method of destruction; and

        • (d) the date of destruction.

      • Annual report
        • 28.5 (1) Subject to subsections (2) and (3), a licensed dealer must provide to the Minister, within three months after the end of each calendar year, an annual report that contains

          • (a) the name, form and total quantity of each narcotic that they receive, produce, sell, provide, import, export or destroy during the calendar year, as well as the name and total quantity of each narcotic that they use to manufacture or assemble a product or compound;

          • (b) the name, form and quantity of each narcotic in physical inventory taken at the site specified in their licence at the end of the calendar year; and

          • (c) the name, form and quantity of any narcotic that has been lost or stolen in the course of conducting activities during the calendar year.

        • Non-renewal or revocation within first three months

          (2) If a licensed dealer’s licence expires without being renewed or is revoked during the first three months of a calendar year, the dealer must provide to the Minister

          • (a) within three months after the end of the preceding calendar year, the annual report in respect of that year; and

          • (b) within three months after the expiry or revocation, a report in respect of the portion of the current calendar year during which the licence was valid that contains the information referred to in subsection (1), in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

        • Non-renewal or revocation after third month

          (3) If a licensed dealer’s licence expires without being renewed or is revoked after the first three months of a calendar year, the dealer must provide to the Minister, within three months after the expiry or revocation, a report in respect of the portion of the calendar year during which the licence was valid that contains the information referred to in subsection (1) for that period, in which the quantity in physical inventory is to be calculated as of the date of expiry or revocation.

      • Retention period

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

      • Location

        29.1 The documents must be kept

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

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

      • Quality of documents

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

  • — SOR/2019-169, s. 4

    • 4 The Regulations are amended by adding the following before section 30:

      Record of Narcotics Received

  • — SOR/2019-169, s. 5

    • 5 The Regulations are amended by adding the following before section 31:

      Sale of Narcotics

  • — SOR/2019-169, s. 6

      • 6 (1) Paragraphs 31(2)(b) and (c) are replaced by the following:

        • (b) except in the case of diacetylmorphine (heroin), if the pharmacist has received a written order or prescription for the narcotic that is signed and dated by a practitioner and has verified the signature of the practitioner, if it is not known to them; or

        • (c) in the case of diacetylmorphine (heroin), if the pharmacist has received a written order or prescription for the narcotic that is signed and dated by a practitioner of medicine or a nurse practitioner and has verified the signature of the practitioner, if it is not known to them.

      • (2) Subsection 31(2.1) of the Regulations is repealed.

  • — SOR/2019-169, s. 7

    • 7 Paragraphs 32(d) and (e) of the Regulations are replaced by the following:

      • (d) dispense, sell or provide a narcotic, other than a verbal prescription narcotic, to a practitioner named in a notice issued by the Minister under subsection 59(1) or fill a prescription or order for a narcotic, other than a verbal prescription narcotic, from a practitioner named in such a notice; or

      • (e) dispense, sell or provide a verbal prescription narcotic to a practitioner named in a notice issued by the Minister under subsection 59(1) or fill a prescription or order for a verbal prescription narcotic from a practitioner named in such a notice.

  • — SOR/2019-169, s. 8

    • 8 The portion of section 33 of the French version of the Regulations before paragraph (a) is replaced by the following:

      • 33 L’article 32 ne s’applique pas au pharmacien auquel le ministre a donné un avis de rétractation de l’avis :

  • — SOR/2019-169, s. 9

    • 9 Section 34 of the Regulations is replaced by the following:

      • Verbal prescription narcotic

        34 Subject to section 39, a pharmacist may dispense a verbal prescription narcotic on receipt of a verbal order or prescription given by a person whom the pharmacist has taken reasonable precautions to determine is a practitioner.

  • — SOR/2019-169, s. 10

      • 10 (1) Paragraph 35(1)(a) of the Regulations is replaced by the following:

        • (a) the pharmacist in charge of the hospital’s pharmacy;

      • (2) Paragraphs 35(1)(b) and (c) of the French version of the Regulations are replaced by the following:

        • b) sauf s’il s’agit de diacétylmorphine (héroïne), un praticien qui est autorisé à signer la commande par le responsable de l’hôpital;

        • c) s’agissant de diacétylmorphine (héroïne), un médecin, un infirmier praticien ou un dentiste qui est autorisé à signer la commande par le responsable de l’hôpital.

  • — SOR/2019-169, s. 11

    • 11 Sections 37 to 40 of the Regulations are replaced by the following:

      • Maximum Quantity

        37 A pharmacist must not use an order or prescription to dispense a narcotic after the quantity of the narcotic specified in the order or prescription has been dispensed.

      Records

      • Written order or prescription

        38 If, in accordance with a written order or prescription, a pharmacist dispenses a narcotic, other than dextropropoxyphene, the pharmacist must immediately enter in a book, register or other record maintained for such purposes

        • (a) their name or initials;

        • (b) the name, initials and municipal address of the practitioner who issued the order or prescription;

        • (c) the name and municipal address of the person named in the order or prescription;

        • (d) the name, form and quantity of the narcotic;

        • (e) the date on which the narcotic was dispensed; and

        • (f) the number assigned to the order or prescription.

      • Verbal order or prescription

        39 A pharmacist must, before dispensing a verbal prescription narcotic in accordance with a verbal order or prescription, make a written record of it that sets out

        • (a) their name or initials;

        • (b) the name, initials and municipal address of the practitioner who issued the order or prescription;

        • (c) the name and municipal address of the person named in the order or prescription;

        • (d) in accordance with the manner in which it is specified in the order or prescription, the name and quantity of the verbal prescription narcotic or the narcotic and the other medicinal ingredients contained in it;

        • (e) the directions for use given with the order or prescription;

        • (f) the date on which the verbal prescription narcotic was dispensed; and

        • (g) the number assigned to the order or prescription.

      • File by date and number

        40 A pharmacist must maintain a special narcotic prescription file in which are filed, in sequence as to date and number, all written orders and prescriptions for narcotics that they have dispensed and the written record of all verbal prescription narcotics that they have dispensed in accordance with a verbal order or prescription.

      • Retention period

        40.1 A pharmacist must retain in their possession for a period of at least two years any records which they are required to keep by these Regulations.

  • — SOR/2019-169, s. 12

    • 12 The Regulations are amended by adding the following before section 41:

      General Obligations of Pharmacist

  • — SOR/2019-169, s. 13

    • 13 The Regulations are amended by adding the following before section 45:

      Return or Emergency Sale

  • — SOR/2019-169, s. 14

    • 14 Section 46 of the Regulations is replaced by the following:

      Communication of Information by Minister to Licensing Authority

      • Contraventions by pharmacist

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

        • (a) in the province in which the pharmacist is or was entitled to practise if

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

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

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

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

            • (C) contravened these Regulations; or

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

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

          • (ii) a document that shows that

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

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

      Notice of Prohibition of Sale

  • — SOR/2019-169, s. 15

    • 15 Sections 48 and 49 of the Regulations are replaced by the following:

      • Notice by Minister
        • 48 (1) In the circumstances described in subsection (2), the Minister must send a notice to the persons and authorities specified in subsection (3) advising them that pharmacists practising in the notified pharmacies and licensed dealers must not sell or provide to the pharmacist named in the notice one or more of the following:

          • (a) a narcotic, other than a verbal prescription narcotic;

          • (b) a verbal prescription narcotic, other than a preparation mentioned in section 36; or

          • (c) a preparation mentioned in section 36.

        • Circumstances requiring a notice

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

          • (a) made a request to the Minister in accordance with section 47 to send the notice;

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

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

        • Recipients

          (3) The notice must be sent to

          • (a) all licensed dealers;

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

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

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

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

        • Other circumstances

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

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

          • (b) has, on more than one occasion, self-administered a narcotic, other than a verbal prescription narcotic, contrary to accepted pharmaceutical practice;

          • (c) has, on more than one occasion, self-administered a verbal prescription narcotic, other than a preparation mentioned in section 36, contrary to accepted pharmaceutical practice;

          • (d) has, on more than one occasion, provided or administered a narcotic, other than a verbal prescription narcotic, to a person who is a spouse, common-law partner, parent or child of the pharmacist, including a child adopted in fact, contrary to accepted pharmaceutical practice;

          • (e) has, on more than one occasion, provided or administered a verbal prescription narcotic, other than a preparation mentioned in section 36, to a person who is a spouse, common-law partner, parent or child of the pharmacist, including a child adopted in fact, contrary to accepted pharmaceutical practice; or

          • (f) is unable to account for the quantity of narcotic for which the pharmacist was responsible under these Regulations.

        • Measures before sending notice

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

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

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

          • (c) considered

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

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

      • Notice of retraction

        49 The Minister must provide the licensed dealers, pharmacies and provincial professional licensing authorities who were sent a notice under subsection 48(1) with a notice of retraction of that notice if

        • (a) in the circumstance described in paragraph 48(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 a circumstance described in any of paragraphs 48(2)(b) and (c) and (4)(a) to (f), the pharmacist named in the notice has

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

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

  • — SOR/2019-169, s. 16

    • 16 The Regulations are amended by adding the following before section 53:

      Administer, Prescribe or Sell Narcotics

  • — SOR/2019-169, s. 17

    • 17 Paragraphs 54(1)(a) and (b) of the Regulations are replaced by the following:

      • (a) three times the maximum daily dosage recommended by the manufacturer or assembler of the narcotic for that narcotic; or

      • (b) three times the generally recognized maximum daily therapeutic dosage for the narcotic if the manufacturer or assembler has not recommended a maximum daily dosage.

  • — SOR/2019-169, s. 18

    • 18 The Regulations are amended by adding the following before section 55:

      General Obligations of Practitioner

  • — SOR/2019-169, s. 19

    • 19 Section 57 of the Regulations is replaced by the following:

      Communication of Information by Minister to Licensing Authority

      • Contraventions by practitioner

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

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

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

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

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

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

            • (C) contravened these Regulations; or

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

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

          • (ii) a document that shows that

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

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

      Notice of Prohibition of Sale

  • — SOR/2019-169, s. 20

    • 20 Sections 59 and 60 of the Regulations are replaced by the following:

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

          • (a) pharmacists practising in the notified pharmacies and licensed dealers must not sell or provide to the practitioner named in the notice a narcotic other than a verbal prescription narcotic or a verbal prescription narcotic;

          • (b) pharmacists practising in the notified pharmacies must not fill a prescription or order from the practitioner named in the notice for a narcotic other than a verbal prescription narcotic or a verbal prescription narcotic; or

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

        • Circumstances requiring a notice

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

          • (a) made a request to the Minister in accordance with section 58 to send the notice;

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

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

        • Recipients

          (3) The notice must be sent to

          • (a) all licensed dealers;

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

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

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

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

        • Other circumstances

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

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

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

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

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

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

          • (f) is unable to account for the quantity of narcotic for which the practitioner was responsible under these Regulations.

        • Measures before sending notice

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

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

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

          • (c) considered

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

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

      • Notice of retraction

        60 The Minister must provide the licensed dealers, pharmacies and provincial professional licensing authorities who were sent a notice under subsection 59(1) with a notice of retraction of that notice if

        • (a) in the circumstance described in paragraph 59(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 a circumstance described in any of paragraphs 59(2)(b) and (c) and (4)(a) to (f), the practitioner named in the notice has

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

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

  • — SOR/2019-169, s. 21

      • 21 (1) The portion of section 63 of the French version of the Regulations before paragraph (a) is replaced by the following:

        • 63 Le responsable d’un hôpital satisfait aux exigences suivantes :

      • (2) Subparagraph 63(a)(v) of the French version of the Regulations is replaced by the following:

        • (v) du nom du malade pour lequel a été dispensé un stupéfiant autre qu’un stupéfiant d’ordonnance verbale ou que du dextropropoxyphène,

  • — SOR/2019-169, s. 22

    • 22 The portion of section 64 of the French version of the Regulations before paragraph (a) is replaced by the following:

      • 64 Le responsable d’un hôpital satisfait aux exigences suivantes :

  • — SOR/2019-169, s. 23

      • 23 (1) Subsection 65(1) of the French version of the Regulations is replaced by the following:

        • (1) Il est interdit au responsable d’un hôpital de permettre qu’un stupéfiant soit administré, vendu ou fourni si ce n’est en conformité avec le présent article.

      • (2) Subsection 65(2) of the Regulations is replaced by the following:

        • (2) On receipt of a written order or prescription signed and dated by a practitioner, the person in charge of a hospital may permit a narcotic, other than diacetylmorphine (heroin), to be administered to a person or an animal under treatment as an in-patient or out-patient of the hospital, or to be sold or provided for the person or to the person in charge of the animal.

        • (2.1) On receipt of a verbal prescription given by a practitioner, the person in charge of a hospital may permit a verbal prescription narcotic to be administered to a person or an animal under treatment as an in-patient or out-patient of the hospital, or to be sold or provided for the person or to the person in charge of the animal.

      • (3) Subsection 65(3) of the French version of the Regulations is replaced by the following:

        • (3) Sous réserve du paragraphe (5.1), le responsable d’un hôpital peut, à la réception d’une commande écrite qui est signée et datée par un pharmacien d’un autre hôpital ou par un praticien autorisé à signer celle-ci par le responsable de l’autre hôpital, permettre qu’un stupéfiant soit fourni pour une urgence à un employé de l’autre hôpital ou à un praticien exerçant dans celui-ci.

      • (4) Subsection 65(4) of the French version of the Regulations is replaced by the following:

        • (4) Sous réserve du paragraphe (5.1), le responsable d’un hôpital peut, à la réception d’une commande écrite, signée et datée par un pharmacien permettre qu’un stupéfiant soit vendu ou fourni pour une urgence à celui-ci.

      • (5) Subsection 65(5.1) of the French version of the Regulations is replaced by the following:

        • (5.1) Il est interdit au responsable d’un hôpital de permettre que le stupéfiant soit vendu ou fourni en vertu des paragraphes (3) ou (4) à moins que la personne qui vend ou fournit le stupéfiant vérifie la signature, lorsqu’elle ne la reconnaît pas, du pharmacien de l’autre hôpital ou du praticien autorisé à signer une commande par le responsable de l’autre hôpital.

      • (6) Subsection 65(6) and (7) of the Regulations are replaced by the following:

        • (6) A person in charge of a hospital may permit a narcotic to be provided to a person who is exempted under section 56 of the Act with respect to the possession of the narcotic and who is employed in a research laboratory in the hospital for the purpose of research.

        • (7) The person in charge of a hospital may permit diacetylmorphine (heroin) to be sold, provided or administered to a person under treatment as an in-patient or out-patient of the hospital on receipt of a written order or prescription signed and dated by a practitioner of medicine or dentistry or a nurse practitioner.

  • — SOR/2019-169, s. 24

    • 24 Sections 68 to 70 of the Regulations are replaced by the following:

      • Identification or analysis of narcotic
        • 68 (1) Despite anything in these Regulations, a person may, for the purpose of identification or analysis of a narcotic, provide or deliver it to

          • (a) a practitioner of medicine; or

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

        • Agent or mandatary of practitioner of medicine

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

          • (a) the practitioner; or

          • (b) the Minister.

        • Practitioner of medicine

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

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

          • (b) to the Minister.

      • Records — person who is exempted or who has received a narcotic for the purpose of identification or analysis

        69 Every person who is exempted under section 56 of the Act with respect to the possession of a narcotic — other than a person to whom a narcotic has been administered, sold, delivered or provided by a practitioner of medicine who is exempted under section 56 of the Act from the application of any subsection of section 53 with respect to that narcotic —, every practitioner of medicine who has received a narcotic under subsection 68(1) or (2) and every agent or mandatary of a practitioner of medicine who has received a narcotic under subsection 68(1) must

        • (a) keep a record of the following information for a two-year period beginning on the day on which the record is made

          • (i) the name and quantity of any narcotic purchased or received by them and the date on which it was purchased or received,

          • (ii) the name and address of the person from whom the narcotic was purchased or received, and

          • (iii) particulars of the use to which the narcotic was put;

        • (b) provide any information respecting the narcotic that the Minister may require; and

        • (c) permit access to the records that are required to be kept by these Regulations.

      • Advertising

        70 It is prohibited to

        • (a) advertise a narcotic to the general public;

        • (b) advertise a preparation referred to in section 36 in a pharmacy; or

        • (c) publish any written advertisement respecting a narcotic unless that advertisement displays the symbol “N” in a clear and conspicuous colour and size in the upper left quarter of its first page.

  • — SOR/2019-169, s. 25

    • 25 Section 71 of the Regulations is repealed.

  • — SOR/2019-169, s. 26

    • 26 Section 72 of the Regulations is replaced by the following:

      • Notification of application for order of restoration
        • 72 (1) For the purpose of subsection 24(1) of the Act, notification of an application for an order of restoration must be given in writing to the Attorney General by registered mail and be mailed at least 15 days before the date on which the application is to be made to a justice.

        • Content of notice

          (2) The notification must specify

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

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

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

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

  • — SOR/2019-169, s. 27

    • 27 Sections 73 and 74 of the Regulations are replaced by the following:

      • Communication of information by Minister to nursing statutory body
        • 73 (1) The Minister may provide to a nursing statutory body any information concerning any member of that body that has been obtained under these Regulations or the Act.

        • Non-application

          (2) Subsection (1) does not apply to a nurse practitioner.

        • Definitions

          (3) The following definitions apply in this section.

          member

          member means any person who is authorized by a nursing statutory body to practice nursing. (membre)

          nursing statutory body

          nursing statutory body means any provincial professional licensing authority that, in accordance with the laws of that province, authorizes a person to practise nursing. (organisme régissant la profession d’infirmier)

      • Exemption — member of police force

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

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