Division 2: Licences And Licensed Dealers

G.02.001. Subject to this Part, no person except a licensed dealer shall produce, make, assemble, import, export, sell, provide, transport, send or deliver a controlled drug.

G.02.001.1. To be eligible for a dealer's licence, a person must be

(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 controlled drugs on behalf of a department of the Government of Canada or of a government of a province, a police force, a hospital or a university in Canada.

G.02.001.2. (1) A licensed dealer

(a) shall designate no more than one qualified person in charge, who may be the licensed dealer if the licensed dealer is an individual, who must work at the premises specified in the licence, have responsibility for supervising activities with respect to controlled drugs specified in the licence and for ensuring on behalf of the licensed dealer that those activities comply with these Regulations; and

(b) may designate an alternate qualified person in charge who must work at the premises specified the licence and have authority to replace the qualified person in charge when that person is absent.

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

(a) shall be familiar with the provisions of the Act and the regulations under it that apply to the licence of the licensed dealer who designated them and have knowledge of chemistry and pharmacology and experience in those fields to properly carry out their duties;

(b) shall be a pharmacist or a practitioner registered with a licensing body of a province or possess a degree in an applicable science — such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, organic chemistry or chemical engineering — that is awarded by a Canadian university or, if awarded by a foreign university, that is recognized by a Canadian university or a Canadian professional association; and

(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii).

G.02.002. No licensed dealer may import or export a controlled drug without a permit.

G.02.002.1 A licensed dealer is authorized to have a controlled drug in his possession for the purpose of exporting the controlled drug from Canada if he has obtained the controlled drug pursuant to these Regulations.

G.02.003. (1) To apply for a dealer's licence, a person shall submit an application to the Minister containing

(ii) a corporation, the corporation's name and any other name registered with a province, under which it intends to carry out the activities specified in its dealer's licence or intends to identify itself; and

(iii) the holder of a position mentioned in paragraph G.02.001.1(c), the applicant's name and the title of the position;

(b) the address, telephone number and, if applicable, the facsimile number and e-mail address for the premises to which the dealer's licence would apply and, if different, the mailing address for the premises;

(d) with respect to the qualified person in charge and, if applicable, the alternate qualified person in charge at the premises,

(ii) their academic qualifications, training and work experience relevant to their duties,

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

(e) the name and gender of the individuals authorized to place an order for a controlled drug on behalf of the applicant;

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

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

(g) the activities referred to in section G.02.001 for which the licence is sought that would be carried out at the premises to which the dealer's licence would apply;

(h) if the licence is sought to produce a controlled drug other than a product or compound that contains a controlled drug,

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

(iii) if the controlled drug would be produced for another licensed dealer under a custom order, the name, address and dealer's licence number of the other dealer;

(i) a detailed description of the security measures at the premises, determined in accordance with the Security Directive;

(j) a detailed description of the method that the applicant proposes to use for recording their controlled drug transactions; and

(k) for any activity referred to in section G.02.001, other than the activities described in paragraphs (f) and (h), the controlled drug and the purpose for carrying out the activity.

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

(b) be accompanied by a statement signed by the individual in charge indicating that

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

(a) declarations signed by the individual in charge of the premises, the qualified person in charge and, if applicable, the alternate qualified person in charge, stating that they have not been convicted, as an adult, during the preceding 10 years of

(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii);

(b) a document issued by a Canadian police force with respect to each of the persons referred to in paragraph (a), stating whether the person has or has not been convicted, as an adult, during the preceding 10 years, of a designated drug offence or a designated criminal offence;

(c) if any of the persons referred to in paragraph (a) has ordinarily resided in a country other than Canada during the preceding 10 years, a document issued by a police force of that country stating whether the person has or has not been convicted in that country, as an adult, during the preceding 10 years, of an offence that would have constituted a designated drug offence or a designated criminal offence if committed in Canada;

(d) a statement, signed and dated by the individual in charge of the premises to which the application applies, stating that the qualified person in charge and, if applicable, the alternate qualified person in charge have the knowledge and experience required under paragraph G.02.001.2(2)(a);

(e) if the qualified person in charge or, if applicable, the alternate qualified person in charge is not a pharmacist or a practitioner registered with a licensing body of a province, a copy of the person's degree required under paragraph G.02.001.2(2)(b) and a copy of the course transcript for that degree;

(f) if the applicant's name appears on the label of a product or compound that contains a controlled drug, a copy of the inner label, as defined in section A.01.010, for each product or compound to which the licence would apply; and

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

(a) allow for the recording of controlled drug transactions in accordance with section G.02.014; and

(b) permit the Minister to audit the activities of the licensed dealer with respect to controlled drugs.

(5) The documents referred to in paragraphs (3)(b) and (c) are not required if the persons referred to in those paragraphs consent in writing

(a) to having a criminal record check carried out for them, as an adult, in respect of the offences referred to in those paragraphs during the preceding 10 years;

(b) to provide all necessary information and to submit to any means of identification required to obtain the criminal record check; and

(c) to pay the fee established by the Royal Canadian Mounted Police, Criminal Record Verification for Civil Purposes Fee Regulations.

G.02.003.1. The Minister may, on receiving an application made under this Part, require the submission of any additional information that pertains to the information contained in the application and that is necessary for the Minister to process the application.

G.02.003.2. Subject to section G.02.003.3, the Minister shall, after examining the information and documents required under sections G.02.003 and G.02.003.1, issue a dealer's licence that contains

(b) the name of the applicant or the title of the position they hold, as the case may be, or, if the applicant is a corporation, its corporate name;

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

(h) the expiry date of the licence, which may not be later than three years after its effective date;

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

(j) in the case of a producer of a controlled drug, the quantity of the controlled drug that may be produced under the licence and the period during which that quantity may be produced; and

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

(iv) the strength per unit of the controlled drug in each product or compound, and

G.02.003.3. (1) The Minister shall refuse to issue, renew or amend a dealer's licence if

(b) an inspector who has requested an inspection has not been given the opportunity by the applicant to conduct an inspection under section G.02.015;

(d) an activity for which the licence is requested would not be in compliance with an international obligation;

(e) information received from a competent authority or the United Nations raises a reasonable belief that the applicant has been involved in the diversion of a controlled drug to an illicit market or use or has been involved in an activity that was not in compliance with an international obligation;

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

(g) the applicant is in contravention of or has contravened during the preceding 10 years

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

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

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

(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii);

(j) the proposed method referred to in paragraph G.02.003(1)(j) is not capable of recording controlled drug transactions as required under section G.02.014 or permitting the Minister to audit the applicant's activities with respect to controlled drugs in a timely manner; or

(k) the additional information required under section G.02.003.1 has not been provided or is insufficient to process the application.

(2) The Minister is not required to refuse to issue, renew or amend a licence under paragraph (1)(c) or (g) if the applicant

(a) does not have a history of non compliance with the Act or any regulation made or continued under it; and

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

G.02.003.4. (1) To apply to renew a dealer's licence, a licensed dealer shall submit to the Minister

(i) the documents referred to in paragraphs G.02.003(3)(a) and (d) and, subject to subsection G.02.003(5), the document referred to in paragraph G.02.003(3)(b),

(ii) if applicable and if not previously submitted in respect of the dealer's licence that is being renewed, the document referred to in paragraph G.02.003(3)(e), and

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

(b) be accompanied by a statement signed by the individual in charge indicating that

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

(3) Subject to section G.02.003.3, the Minister shall, after examining the information and documents required under subsections (1) and (2) and section G.02.003.1, issue a renewed dealer's licence that contains the information specified in paragraphs G.02.003.2(a) to (k).

G.02.003.5. (1) To have its dealer's licence amended, a licensed dealer shall submit to the Minister

(a) an application in writing describing the proposed amendment, accompanied by the supporting documents referred to in section G.02.003 that are relevant to the proposed amendment; and

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

(b) be accompanied by a statement signed by the individual in charge indicating that

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

(3) Subject to section G.02.003.3, the Minister shall, after examining the application for amendment and the supporting documentation, amend the dealer's licence in accordance with the application and may add any conditions to be met by the holder of the licence to

(b) provide for the security level referred to in paragraph G.02.003.2(f) or the new level required as a result of the amendment being implemented; or

(c) reduce the potential security, public health or safety hazard, including the risk of the controlled drug being diverted to an illicit market or use.

G.02.003.6. (1) A licensed dealer shall

(a) obtain the Minister's approval before making any of the following changes, namely,

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

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

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

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

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

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

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

(ii) the declarations specified in paragraph G.02.003(3)(a) and, subject to subsection G.02.003(5), the documents specified in paragraphs G.02.003(3)(b) and (c);

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

(ii) the documents specified in paragraphs G.02.003(3)(a), (d) and (e) and, subject to section G.02.003(5), the documents specified in paragraphs G.02.003(3)(b) and (c); and

(c) in the case of the replacement or addition of an individual who is authorized to place an order for a controlled drug on behalf of the licensed dealer, the individual's name and gender.

G.02.003.7. The Minister shall revoke a dealer's licence at the request of the licensed dealer or on being notified by the licensed dealer that the licence has been lost or stolen.

G.02.003.8. (1) Subject to subsection (2), the Minister shall revoke a dealer's licence in accordance with section G.02.003.91 if

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

(b) the licensed dealer has failed to comply with a provision of the Act, a regulation under it or a term or condition of the licence or of an import or export permit issued under this Part;

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

(iii) an offence committed outside Canada that, if committed in Canada, would have constituted an offence referred to in subparagraph (i) or (ii); or

(e) information received from a competent authority or the United Nations raises a reasonable belief that the licensed dealer has been involved in the diversion of a controlled drug to an illicit market or use.

(2) The Minister is not required to revoke a dealer's licence under paragraph (1)(a) or (b) if the licensed dealer

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

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

G.02.003.9. The Minister shall suspend a dealer's licence without prior notice if it is necessary to do so to protect security, public health or safety, including preventing a controlled drug from being diverted to an illicit market or use.

G.02.003.91. (1) If the Minister proposes to refuse to issue, amend or renew, or proposes to revoke, a dealer's licence under this Part, the Minister shall

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

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

(2) The suspension of a dealer's licence under this Part takes effect as soon as the Minister notifies the holder of the licence of the decision to suspend and provides a written report that sets out the reasons for the suspension.

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

G.02.004. A licensed dealer may, subject to the terms and conditions of their licence, produce, make, assemble, sell, provide, transport, send or deliver only the controlled drugs specified in their dealer's licence.

G.02.005. to G.02.007 [Repealed, SOR/2004-238, s. 4]

G.02.008. The Minister may, upon application therefor, issue a permit to any licensed dealer for the importation or exportation of a controlled drug.

G.02.009. An application for a permit shall be in a form approved by the Minister.

G.02.010. Every licence or permit issued under this Part is subject to the condition that the licensed dealer will comply with the provisions of this Part.

G.02.011. The Minister shall revoke or suspend a permit issued under this Part if the Minister determines that the person to whom the permit was issued has failed to comply with any term or condition of the permit or any provision of these Regulations.

G.02.012. A dealer's licence is valid until the earlier of

(b) the revocation or suspension of the licence under section G.02.003.7, G.02.003.8 or G.02.003.9.

G.02.013. A permit issued under section G.02.008 is valid only for the particular importation or exportation in respect of which it was issued.

G.02.014. (1) Every licensed dealer shall keep a record of the following:

(a) the name and quantity of any controlled drug received by the licensed dealer, the name and address of the person who sold or provided it and the date it was received;

(b) the name, quantity and form of any controlled drug sold or provided by the licensed dealer, the name and address of the person to whom it was sold or provided and the date it was sold or provided;

(c) the name and quantity of any controlled drug used in the making or assembling of a product or compound containing that narcotic, the name and quantity of the product or compound made or assembled and the date on which the product or compound was placed in stock;

(c.1) the name and quantity of any narcotic produced and the date on which it was placed in stock; and

(d) the name and quantity of any controlled drug he had in stock at the end of each month.

(b) subject to subsection (3), in a book, register or similar record maintained exclusively for controlled drugs; and

(3) The record of information referred to in paragraphs (1)(a), (b) and (d) may, with respect to a controlled drug listed in Part II or III of the schedule to this Part, be kept in a form other than that specified in paragraph (2)(b).

G.02.015. (1) The Minister may, in respect of an applicant for a dealer's licence or a licensed dealer, require an inspection, at any reasonable time, of

(a) the premises used or intended to be used in producing, making, assembling or storing a controlled drug; and

(2) The Minister may, in respect of a licensed dealer, require a verification to be made, at any reasonable time, of the qualifications of its technical staff concerned with producing, making, assembling or storing a controlled drug.

G.02.016. Every licensed dealer shall

(a) furnish such information respecting the dealings of such person in any controlled drug in such form and at such times as the Minister may require;

(b) produce to an inspector any books, records or documents required to be kept by this Part;

(d) permit an inspector to check all stock of controlled drugs located on the premises described in the licence of the licensed dealer.

G.02.017. [Repealed, SOR/78-427, s. 3]

G.02.018. Every licensed dealer shall notify the Minister promptly of changes in the following:

(b) the premises in which a controlled drug is produced, made, assembled or stored; and

G.02.019. Every licensed dealer shall

(a) provide such protection against loss or theft of any controlled drug in his possession as may be required by the Minister;

(b) report to the Minister any loss or theft of a controlled drug within 10 days of his discovery thereof; and

(c) securely pack a controlled drug in its immediate container and seal it in such a manner that it cannot be opened without breaking the seal.

G.02.020. A licensed dealer may only import into or export out of Canada a controlled drug at the place specified in his permit.

G.02.021. A licensed dealer shall securely pack in a package sealed in such a manner that it cannot be opened without breaking the seal any controlled drug intended for export out of Canada.

G.02.022. A licensed dealer shall in taking delivery of a controlled drug imported by him or in making delivery of a controlled drug

(a) take such steps as are necessary to ensure the safekeeping of the drug during transit; and

(b) use such method of transportation as will ensure an accurate record being kept of the drug and of the signatures of any persons having charge of the drug until it is delivered to the consignee.

G.02.023. Notwithstanding section G.02.022, a preparation may be delivered by common carrier.

G.02.024. A licensed dealer shall not sell or provide a controlled drug to any person other than a

(f) a person who has been granted an exemption under section 56 of the Controlled Drugs and Substances Act with respect to the possession of a controlled drug.

G.02.024.1. Subject to section G.02.024.2 and notwithstanding sections G.02.024 and G.02.025, no licensed dealer shall

(a) sell or provide a controlled drug, other than a preparation, to a pharmacist named in a notice given by the Minister under section G.03.017.2;

(b) sell or provide a preparation to a pharmacist named in a notice given by the Minister under section G.03.017.2;

(c) sell or provide a controlled drug, other than a preparation, to a practitioner named in a notice given by the Minister under section G.04.004.2; or

(d) sell or provide a preparation to a practitioner named in a notice given by the Minister under section G.04.004.2.

G.02.024.2. Section G.02.024.1 does not apply to a licensed dealer to whom the Minister has issued a notice of retraction of the notice

(a) under section G.03.017.3, in respect of a pharmacist named in a notice issued by the Minister under section G.03.017.2; or

(b) under section G.04.004.3, in respect of a practitioner named in a notice issued by the Minister under section G.04.004.2.

G.02.025. (1) Subject to this section, a licensed dealer may, in accordance with the terms and conditions of their dealer's licence, sell or provide a controlled drug to a person referred to in section G.02.024 if

(a) the drug is contained in a package that is authorized and described in the dealer's licence of the producer, maker or assembler of the drug; and

(iii) a verbal order for a controlled drug listed in Part II or III of the schedule to this Part

(2) A licensed dealer who has received an order referred to in subparagraph (1)(b)(i) and verified the signature on the order may sell or provide a controlled drug to a person referred to in section G.02.024, if the order is signed and dated by one of the following persons:

(a) if the controlled drug is to be sold or provided to a person referred to in paragraph G.02.024(2)(a), (b), (c), (e) or (f), by that person; or

(b) if the controlled drug is to be provided to a hospital employee or a practitioner in a hospital, by the pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the person in charge of the hospital to sign the order.

(3) A licensed dealer may sell or provide a controlled drug pursuant to an order received from a remote input device through a computer if the computer program and the remote input device meet the requirements of subsections (5) and (6).

(3.1) A licensed dealer who has received an order sent through a computer from a remote input device referred to in subparagraph (1)(b)(ii) may provide a controlled drug to a hospital employee or to a practitioner in a hospital if the order has been placed by the pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the person in charge of the hospital to place the order.

(3.2) A licensed dealer who has received a verbal order referred to in subparagraph (1)(b)(iii) may provide a controlled drug listed in Part II or III of the schedule to this Part to a hospital employee or to a practitioner in a hospital if the order has been placed by the pharmacist in charge of the dispensary of the hospital or by a practitioner authorized by the person in charge of the hospital to place the order.

(4) A licensed dealer who has received a verbal order referred to in subparagraph (1)(b)(iii), and has provided a controlled drug listed in Part II or III of the schedule to this Part to a person referred to in paragraphs G.02.024(b) to (d), shall immediately record

(b) if the drug was provided to a hospital employee or a practitioner in a hospital, the name of the pharmacist in charge of the dispensary of the hospital or the name of the practitioner authorized by the person in charge of the hospital to sign the order; and

(5) For the purposes of this section, a remote input device shall be a device for transmitting electronically orders for drugs, other than by voice communication, that

(a) contains a unique identifying code that can be related to the device and the pharmacist or practitioner in whose possession and care the remote input device has been placed;

(c) is designed in such a way that the unique identifying code for the remote input device is an integral part of the circuitry and can only be modified by the dismantling of the device.

(a) identify the remote input device, the name and address of the pharmacist or practitioner in whose possession and care the remote input device has been placed;

(b) identify the pharmacist or practitioner placing the order by means of an identifying code unique to that pharmacist or practitioner;

(d) detect unusual orders and thereby necessitate manual intervention by the licensed dealer; and

(e) necessitate manual intervention by the licensed dealer if one or more of the check procedures fails.

(7) Where a licensed dealer has received, from a pharmacist or practitioner, an order sent through a computer from a remote input device referred to in subparagraph (1)(b)(ii) or a verbal order referred to in subparagraph (1)(b)(iii), he shall, within five working days of filling the order for a controlled drug, obtain and keep a receipt that includes

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

(8) If a licensed dealer has not received a receipt from a pharmacist or practitioner under subsection (7) within the time prescribed by that subsection, the dealer shall not, until after receiving the receipt, sell or provide a controlled drug to the pharmacist or practitioner pursuant to a further

(a) order sent through a computer from a remote input device referred to in subparagraph (1)(b)(ii); or

SOR/78-220, s. 4; SOR/78-427, s. 4; SOR/85-550, s. 3; SOR/88-482, s. 3(F); SOR/90-261, s. 2(F); SOR/97-228, s. 11; SOR/2004-238, s. 11.

G.02.026. A licensed dealer shall not sell or provide a controlled drug more than once in respect of one order unless

(a) the order for the drug states that the quantity of the drug is to be sold or provided

(b) at the time of receipt of the order the licensed dealer temporarily does not have in stock the quantity of the drug ordered, in which case the dealer may sell or provide against the order the quantity of the drug that the dealer has available and deliver the balance later in accordance with the order.

G.02.027. [Repealed, SOR/80-543, s. 12]