Canada Gazette, Part I, Volume 152, Number 25: Regulations Amending the Food and Drug Regulations (Parts G and J — Licences and Permits)

June 23, 2018

Statutory authority
Controlled Drugs and Substances Act

Sponsoring department
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

For the Regulatory Impact Analysis Statement, see the Regulations Amending the Narcotic Control Regulations (Licences and Permits).

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to subsection 55(1) ^{footnote a} of the Controlled Drugs and Substances Act ^{footnote b}, proposes to make the annexed Regulations Amending the Food and Drug Regulations (Parts G and J — Licences and Permits).

Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to the Office of Legislative and Regulatory Affairs, Controlled Substances Directorate, Healthy Environments and Consumer Safety Branch, Department of Health, Address Locator 0302A, 150 Tunney's Pasture Driveway, Ottawa, Ontario, K1A 0K9 (email: ocs_regulatorypolicy-bsc_politiquereglementaire@hc-sc.gc.ca).

Ottawa, June 7, 2018

Jurica Čapkun
Assistant Clerk of the Privy Council

Regulations Amending the Food and Drug Regulations (Parts G and J — Licences and Permits)

Amendments

1 Divisions 1 and 2 of Part G of the Food and Drug Regulations ^{footnote 1} are replaced by the following:

DIVISION 1

Definitions

Definitions
G.01.001 The following definitions apply in this Part.

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

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

agricultural implant means a product that is presented in a form suitable to allow sustained release of an active ingredient over a certain period of time and that is intended for insertion under the skin of a food-producing animal for the purpose of increasing weight gain and improving feed efficiency. (implant agricole)

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 controlled drugs into or from the country. (autorité compétente)

compound includes a preparation. (composé)

controlled drug means a controlled substance set out in the schedule to this Part. (drogue contrôlée)

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

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

label has the same meaning as in section 2 of the Food and Drugs Act. (étiquette)

licensed dealer means the holder of a licence issued under section G.02.007. (distributeur autorisé)

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

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

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

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

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

preparation means a drug that contains a controlled drug and an active medicinal ingredient in a recognized therapeutic dose, other than a controlled drug.. (préparation)

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

qualified person in charge means the individual designated under subsection G.02.004(1). (responsable qualifié)

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

senior person in charge means the individual designated under section G.02.003. (responsable principal)

test kit means a kit

(a) that contains a controlled drug and a reagent system or buffering agent;
(b) that is designed to be used during the course of a chemical or analytical procedure to test for the presence or quantity of a controlled drug 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)

Application

Agricultural implants
G.01.002 The Act and this Part do not apply in respect of a controlled drug that is contained in an agricultural implant and set out in Part III of the schedule to this Part, but nothing in this section exempts such a drug from the requirements of Part C.

Member of police force
G.01.003 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 this Part.

Application of Parts C and D
G.01.004 Except as otherwise provided in this Part, no person shall sell a controlled drug or preparation that does not comply with all provisions of Parts C and D applicable to it.

Possession

Authorized persons
G.01.005 (1) A person is authorized to possess a controlled drug set out in any of items 1 to 3, 8 to 10, 12 to 14, 16 or 17 of Part I of the schedule to this Part if the person has obtained the controlled drug 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 controlled drug, and the person

(a) requires the controlled drug 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 that drug;
(b) is a practitioner who is registered and entitled to practise in a province other than the province in which they have that possession and their possession is for emergency medical purposes only;
(c) is a hospital employee or a practitioner in a hospital;
(d) has obtained the controlled drug for their own use
- (i) from a practitioner, or
- (ii) in accordance with a prescription that was not issued or obtained in contravention of these Regulations,
(e) is a practitioner of medicine who received the controlled drug under subsection G.06.003(1) or (2) and their possession is for the purpose of providing or delivering it to a person referred to in subsection G.06.003(3);
(f) is an agent or mandatary of a practitioner of medicine who received the controlled drug under subsection G.06.003(1) and their possession is for the purpose of providing or delivering it to a person referred to in subsection G.06.003(2);
(g) is employed as an inspector, a member of the Royal Canadian Mounted Police, a police constable, peace officer or 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 possession of that controlled drug 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 controlled drug referred to in subsection (1) if the person is acting as the agent or mandatary of any person who is authorized to possess it in accordance with any of paragraphs (1)(a) to (e), (h) and (i).

Agent or mandatary — person referred to in paragraph (1)(g)
(3) A person is authorized to possess a controlled drug referred to in subsection (1) if

(a) the person is acting as the agent or mandatary of a person that they have reasonable grounds to believe is a person referred to in paragraph (1)(g); and
(b) their possession of the controlled drug is for the purpose of assisting that person in the administration or enforcement of an Act or a regulation.

Test Kits

Authorized activities
G.01.006 A person may sell, possess or otherwise deal in a test kit if

(a) a registration number has been issued for the test kit under section G.01.008 and has not been cancelled under section G.01.009;
(b) the test kit bears, on its external surface,
- (i) the name of the manufacturer,
- (ii) the trade name or trademark, and
- (iii) the registration number; and
(c) the test kit is sold, possessed or otherwise dealt in for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose.

Application for registration number
G.01.007 (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 controlled drug 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 shall

(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 shall provide the Minister with any information or document that the Minister determines is necessary to complete the Minister's review of the application, not later than the date specified in the Minister's written request to that effect.

Issuance of registration number
G.01.008 On completion of the review of the application for a registration number, the Minister shall issue a registration number for the test kit, preceded by the letters "TK", if the Minister is satisfied that the test kit will only be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose and that it

(a) contains a controlled drug 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) contains such small quantities or concentrations of any controlled drug as to have no significant drug abuse potential.

Cancellation of registration number
G.01.009 The Minister shall 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 preventing a controlled drug from being diverted to an illicit market or use.

DIVISION 2

Licensed Dealers

Authorized Activities

General
G.02.001 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a controlled drug if they comply with

(a) the terms and conditions of their licence and any permit issued under this Part; and
(b) this Part.

Qualified person in charge present
(2) A licensed dealer may conduct an activity in relation to a controlled drug 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 shall obtain a permit to import or export a controlled drug.

Possession for export
(4) A licensed dealer may posses a controlled drug for the purpose of exporting it if they have obtained it in accordance with this Part.

Licences

Preliminary Requirements

Eligible persons
G.02.002 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 controlled drugs on behalf of the Government of Canada, the government of a province, a police force, a hospital or a university in Canada.

Senior person in charge
G.02.003 An applicant for a dealer's licence shall designate only one individual as the senior person in charge, who has overall responsibility for management of the activities with respect to controlled drugs specified in the licence application. The applicant may designate themself if the applicant is an individual.

Qualified person in charge
G.02.004 (1) An applicant for a dealer's licence shall designate only one individual as the qualified person in charge, who is responsible for supervising the activities with respect to controlled drugs that are specified in the licence application and for ensuring that those activities comply with this Part. 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 are
- (i) a person registered 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) the holder of 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) the holder of 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
(c) they have sufficient knowledge of and experience with the use and handling of the controlled drugs specified in the licence to properly carry out their duties; and
(d) they have sufficient knowledge of the provisions of the Act and this Part that are applicable to the activities specified in the 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
G.02.005 A person 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, the person
- (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,
- (i) the person was convicted as an adult, or
- (ii) if they committed the offence when they were at least 14 years old but not less than 18 years old, the person 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.

Application, Issuance, Validity and Refusal

Application
G.02.006 (1) A person who intends to conduct an activity referred to in section G.02.001 shall obtain a dealer's licence for each site at which they plan 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 mentioned in paragraph G.02.002(c), the applicant's name and the title of the position;
(b) the municipal address, telephone number and, if applicable, the facsimile number and email address of the proposed site at which activities are to be conducted and, if different from the municipal address, its mailing address;
(c) the name and date of birth of the senior person in charge;
(d) with respect to the proposed qualified person in charge and the proposed alternate qualified person in charge,
- (i) their name and date of birth,
- (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 name of their profession that is relevant to their duties, the name of the province that authorizes them to practise it and their authorization number,
- (v) their education, training and work experience relevant to their duties, and
- (vi) their hours of work at the site,
(e) the activities that are to be conducted and the controlled drugs 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 controlled drug, 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, if any;
- (iii) the name and the strength per unit of the controlled drug in it,
- (iv) its quantity or package sizes,
- (v) if it is to be manufactured or assembled by or for another licensed dealer under a custom order, the name, municipal address and dealer's 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;
(g) if the licence is requested to produce a controlled drug other than a product or compound that contains a controlled drug,
- (i) its name,
- (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 any activity that is not described in paragraphs (f) and (g), the name of the controlled drug 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 G.02.075.

Documents
(2) An application for a dealer's licence shall 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 senior person in charge, the proposed qualified person in charge and the proposed alternate qualified person in charge, attesting that the person is not ineligible for a reason specified in section G.02.005;
(c) a document issued by a Canadian police force in relation to each person referred to in paragraph (b), indicating whether, during the 10 years before the day on which the application is submitted, the person was convicted as specified in subparagraph G.02.005(a)(i) or received a sentence as specified in subparagraph G.02.005(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 G.02.005(b)(i) or received a sentence as specified in subparagraph G.02.005(b)(ii);
(e) a declaration, signed and dated by the senior person in charge, attesting that the proposed qualified person in charge and the proposed alternate qualified person in charge have the knowledge and experience required under paragraphs G.02.004(3)(c) and (d); and
(f) if the proposed qualified person in charge or the proposed alternate qualified person in charge does not meet the requirement of subparagraph G.02.004(3)(b)(i), either
- (i) a copy of the person's diploma, certificate or credential referred to in subparagraph G.02.004(3)(b)(ii) or (iii) and a copy of the course transcript for it, or
- (ii) a detailed description of the education, training or work experience that is required under paragraph G.02.004(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) An application for a dealer's licence shall

(a) be signed and dated by the senior person in charge; and
(b) include an attestation by the senior person in charge that
- (i) all 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 shall provide the Minister with any information or document that the Minister determines is necessary to complete the Minister's review of the application, not later than the date specified in the Minister's written request to that effect.

Issuance
G.02.007 Subject to section G.02.010, on completion of the review of the licence application, the Minister shall 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 controlled drugs in respect of which each activity may be conducted;
(d) the municipal address of the site at which the licensed 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 shall be not later than the day that is 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 potential risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use; and
(i) if the licensed dealer produces a controlled drug, the quantity that they may produce and the authorized production period.

Validity
G.02.008 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 G.02.032 or G.02.033.

Return of licence
G.02.009 A licensed dealer whose licence is not renewed shall return the original of the licence to the Minister as soon as feasible after its expiry.

Refusal
G.02.010 (1) The Minister shall refuse to issue a dealer's licence if

(a) the applicant is not eligible under section G.02.002;
(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 or its regulations, or
- (ii) a term or condition of a licence or permit issued to the applicant under any regulations made under the Act;
(c) during the 10 years before the day on which the licence application is submitted, the senior person in charge, the proposed qualified person in charge or the proposed alternate qualified person in charge was convicted as specified in subparagraph G.02.005(a)(i) or (b)(i) or received a sentence as specified in subparagraph G.02.005(a)(ii) or (b)(ii);
(d) an activity for which the licence is requested would contravene an international obligation;
(e) the applicant does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the licence is requested;
(f) the method referred to in paragraph G.02.006(1)(j) does not permit the recording of information as required under section G.02.075;
(g) the applicant has not complied with the requirements of subsection G.02.006(4) or the information and documents that they have provided are not sufficient to complete the review of the application;
(h) the Minister has reasonable grounds to believe that the applicant has submitted false or misleading information or false or falsified documents in or with the application;
(i) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the applicant has been involved in the diversion of a controlled drug to an illicit market or use or has been involved in an activity that contravened an international obligation; or
(j) the Minister has reasonable grounds to believe that the issuance of the licence would likely create a risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use.

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

(a) the applicant does not have a history of non- compliance with the Act or its 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 and this Part.

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

Renewal

Application
G.02.011 (1) To apply to renew a dealer's licence, a licensed dealer shall submit to the Minister an application that contains the information and documents referred to in subsections G.02.006(1) and (2).

Signature and attestation
(2) An application shall

(a) be signed and dated by the senior person in charge of the site to which the renewed licence would apply; and
(b) include an attestation by the senior person in charge 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 shall provide the Minister with any information or document that the Minister determines is necessary to complete the Minister's review of the application, not later than the date specified in the Minister's written request to that effect.

Renewal
G.02.012 (1) Subject to section G.02.015, on completion of the review of the renewal application, the Minister shall issue a renewed dealer's licence that contains the information specified in section G.02.007.

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 potential risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use.

Validity
G.02.013 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 G.02.032 or G.02.033.

Return of previous licence
G.02.014 The licensed dealer shall, as soon as feasible after the effective date of the renewal, return the original of the previous licence to the Minister.

Refusal
G.02.015 (1) The Minister shall refuse to renew a dealer's licence if

(a) the licensed dealer is no longer eligible under section G.02.002;
(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 or this Part, or
- (ii) a term or condition of a licence or permit issued to the dealer under this Part;
(c) during the 10 years before the day on which the renewal application is submitted, the senior person in charge, the proposed qualified person in charge or the proposed alternate qualified person in charge was convicted as specified in subparagraph G.02.005(a)(i) or (b)(i) or received a sentence as specified in subparagraph G.02.005(a)(ii) or (b)(ii);
(d) an activity for which the renewal is requested would contravene an international obligation;
(e) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the renewal is requested;
(f) the method referred to in paragraph G.02.006(1)(j) does not permit the recording of information as required by section G.02.075;
(g) the licensed dealer has not complied with the requirements of subsection G.02.011(3) or the information or documents that they have provided are not sufficient to complete the review of the application;
(h) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or with the application;
(i) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a controlled drug to an illicit market or use or has been involved in an activity that contravened an international obligation; or
(j) the Minister has reasonable grounds to believe that the renewal of the licence would likely create a risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use.

Exceptions
(2) The Minister shall not refuse to renew a licence under paragraph (1)(b) or (h) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including preventing a controlled drug 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 this Part; 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 and this Part.

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

Amendment

Application
G.02.016 (1) Before making a change affecting any information referred to in section G.02.007 that is contained in their dealer's licence, a licensed dealer shall 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 G.02.006 that are relevant to the proposed amendment.

Signature and attestation

(2) The application shall

(a) be signed and dated by the senior person in charge of the site to which the amended dealer's licence would apply; and
(b) include an attestation by the senior person in charge 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 shall provide the Minister with any information or document that the Minister determines is necessary to complete the Minister's review of the application, not later than the date specified in the Minister's written request to that effect.

Amendment

G.02.017 (1) Subject to section G.02.020, on completion of the review of the amendment application, the Minister shall 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 licence amendment; or
(c) reduce a potential risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use.

Validity

G.02.018 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 G.02.032 or G.02.033.

Return of previous licence

G.02.019 The licensed dealer shall, as soon as feasible after the effective date of the amendment, return the original of the previous licence to the Minister.

Refusal

G.02.020 (1) The Minister shall refuse to amend a dealer's licence if

(a) an activity for which the licence amendment is requested would contravene an international obligation;
(b) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the licence amendment is requested;
(c) the method referred to in paragraph G.02.006(1)(j) does not permit the recording of information as required by section G.02.075;
(d) the licensed dealer has not complied with the requirements of subsection G.02.016(3) or the information or documents that they have provided are not sufficient to complete the review of the 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 with the application; or
(f) the Minister has reasonable grounds to believe that the amendment of the licence would likely create a risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use.

Exceptions

(2) The Minister shall not refuse to amend a licence under paragraph (1)(e) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including preventing a controlled drug 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 this Part; 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 and this Part.

Notice

(3) Before refusing to amend a licence the Minister shall, 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

Application

G.02.021 (1) A licensed dealer shall obtain the Minister's approval before making any of the following changes by submitting a written request to the Minister:

(a) a change affecting the security measures 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 shall provide the Minister with the following with respect to any change referred to in any of subsection (1):

(a) details regarding the change affecting the security measures in place at the site specified in the dealer's licence;
(b) in the case of the senior person in charge,
- (i) the information specified in paragraph G.02.006(1)(c), and
- (ii) the declaration specified in paragraph G.02.006(2)(b) and the documents specified in paragraphs G.02.006(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 G.02.006(1)(d), and
- (ii) the declarations specified in paragraphs G.02.006(2)(b) and (e) and the documents specified in paragraphs G.02.006(2)(c), (d) and (f).

Additional information and documents

Approval

G.02.022 (1) Subject to section G.02.023, on completion of the review of the application, the Minister shall 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 potential risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use.

Refusal

G.02.023 (1) The Minister shall refuse to approve the change if

(a) during the 10 years before the day on which the application is submitted, the proposed senior person in charge, qualified person in charge or alternate qualified person in charge was convicted as specified in subparagraph G.02.005(a)(i) or (b)(i) or received a sentence as specified in subparagraph G.02.005(a)(ii) or (b)(ii);
(b) the licensed dealer has not complied with the requirements of subsection G.02.021(3) or the information or documents that they have provided are not sufficient to complete the review of the application;
(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 with the application; 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 controlled drug being diverted to an illicit market or use.

Exception

(2) The Minister shall 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 and this Part, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including preventing a controlled drug from being diverted to an illicit market or use.

Notice

(3) Before refusing to approve a change, the Minister shall 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

Prior notice

G.02.024 (1) A licensed dealer shall notify the Minister in writing before

(a) making or assembling a product or compound that is not set out in the most recent version of the list referred to in paragraph G.02.006(1)(f) that the licensed dealer has 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 set out in the list.

Information and list

(2) The notice shall contain the information referred to in paragraph G.02.006(1)(f) that is necessary to update the list and shall be accompanied by the revised version of the list.

Notice as soon as feasible

G.02.025 A licensed dealer shall notify the Minister in writing as soon as feasible of

(a) a change at the site at which a controlled drug is produced, assembled or stored; and
(b) a change to the processes used to conduct those activities and the conditions under which they are conducted.

Notice — next business day

G.02.026 A licensed dealer shall notify the Minister in writing, not later than the next business day after the change, that a person is no longer acting as the qualified person in charge or an alternate qualified person in charge.

Notice — 10 days

G.02.027 (1) A licensed dealer shall notify the Minister in writing not later than 10 days after one of the following changes occurs:

(a) a person is no longer acting 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 G.02.006(1)(f) that the licensed dealer has submitted to the Minister.

Information and list

(2) A notice submitted under paragraph (1)(b) shall specify which information referred to in paragraph G.02.006(1)(f) is being changed and shall be accompanied by the revised version of the list.

Notice of cessation of activities

G.02.028 (1) A licensed dealer who intends to cease conducting activities at their site — whether before or on the expiry of their licence — shall notify the Minister in writing to that effect at least 30 days before ceasing those activities.

Content of notice

(2) The notice shall 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 controlled drugs on the site as of that date will be dealt with by the licensed dealer, including
- (i) if some or all of them will be sold or provided to another licensed dealer who 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 who 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 facsimile number and email address of a person whom the Minister may contact for further information after activities have ceased.

Update

(3) After having ceased to conduct the activities, the licensed dealer shall 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 shall be signed and dated by the senior person in charge.

Changes to Terms and Conditions

Adding or modifying term or condition

G.02.029 (1) The Minister may, at a time other than 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 potential risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use.

Notice

(2) Before adding a term or condition to a licence or modifying one, the Minister shall 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 preventing a controlled drug from being diverted to an illicit market or use.

Urgent circumstances — notice

(4) The addition or modification of a term or condition of a licence 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 shall be carried out by the dealer and the date by which the dealer shall do so.

Deletion of a term or condition

G.02.030 (1) The Minister may delete a term or condition of a licence of a licensed dealer if the Minister determines that it is no longer necessary.

Notice

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

Return of previous licence

G.02.031 The licensed dealer shall, as soon as feasible after the effective date of the addition, modification or deletion of a term or condition, return the original of the previous licence to the Minister.

Suspension and Revocation

Suspension

G.02.032 (1) The Minister shall 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 preventing a controlled drug 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 shall be carried out by the dealer and the date by which the dealer shall do so.

Reinstatement of licence

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

Revocation

G.02.033 (1) Subject to subsection (2), the Minister shall revoke a dealer's licence if

(a) the licensed dealer is no longer eligible under section G.02.002;
(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 or this Part, or
- (ii) a term or condition of a licence or permit issued to the dealer under this Part;
(f) during the 10 years before the day on which the licence is revoked, the senior person in charge, the qualified person in charge or the alternate qualified person in charge was convicted as specified in subparagraph G.02.005(a)(i) or (b)(i) or received a sentence as specified in subparagraph G.02.005(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 with the application; 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 controlled drug to an illicit market or use.

Exceptions

(2) The Minister shall 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 preventing a controlled drug 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 this Part; 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 and this Part.

Notice

(3) Before revoking a licence, the Minister shall 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

G.02.034 The licensed dealer shall, as soon as feasible after the effective date of the revocation, return the original of the licence to the Minister.

Import Permits

Application

G.02.035 (1) A licensed dealer shall submit to the Minister, before each importation of a controlled drug, 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 controlled drug 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) in the case of the importation of a product that contains the controlled drug,
- (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, if any, and
- (iii) the strength per unit of the controlled drug in the product;
(d) the name and municipal address, in the country of export, of the exporter from whom the controlled drug is being obtained;
(e) the name of the customs office where the importation is anticipated; and
(f) each proposed mode of transportation to be used and any proposed country of transit or transhipment.

Signature and attestation

(2) The application shall

(a) be signed and dated by the qualified person in charge or the 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

Issuance

G.02.036 Subject to section G.02.039, on completion of the review of the import permit application, the Minister shall issue to the licensed dealer an import permit that contains

(a) the permit number;
(b) the information set out in subsection G.02.035(1);
(c) the effective date of the permit;
(d) the expiry date of the permit, which shall be the 180th day after its effective date or, if it is earlier, the expiry date of the dealer's licence;
(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 potential risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use.

Validity

G.02.037 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 G.02.042 or G.02.043,
(c) the date of the suspension or revocation of the dealer's licence under section G.02.032 or G.02.033, and
(d) the date of the expiry, suspension or revocation of the export permit that applies to the controlled drug to be imported and that is issued by the competent authority in the country of export.

Return of permit

G.02.038 If an import permit expires, the licensed dealer shall, as soon as feasible after its expiry, return the original of the permit to the Minister.

Refusal

G.02.039 (1) The Minister shall refuse to issue an import permit if

(a) the licensed dealer is not authorized by their dealer's licence to import the relevant controlled drug or their dealer's 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 G.02.035(3) or the information or documents that they have provided are not sufficient to complete the review of the 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 with the application;
(f) the licensed dealer has been notified that their application to renew or amend their licence is to 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 controlled drug being diverted to an illicit market or use.

Notice

(2) Before refusing to issue the permit, the Minister shall 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

G.02.040 The holder of an import permit shall provide a copy of the permit to the customs office at the time of importation.

Declaration

G.02.041 The holder of an import permit shall provide the Minister, within 15 days after the day of release of the controlled drug 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 with respect to the controlled drug;
(b) with respect to the controlled drug,
- (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) in the case of the importation of a product that contains the controlled drug,
- (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, if any, and
- (iii) the strength per unit of the controlled drug in the product; and
(d) the name of the customs office from which the controlled drug was released and the date of the release.

Suspension

G.02.042 (1) The Minister shall 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 the risk of a controlled drug 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 shall be carried out by the dealer and the date by which the dealershall do so.

Reinstatement of permit

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

Revocation

G.02.043 (1) Subject to subsection (2), the Minister shall 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 G.02.042(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 with the application;
(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 controlled drug to an illicit market or use; or
(f) the dealer's licence has been revoked.

Exceptions

(2) The Minister shall not revoke an import permit for a ground set out in paragraph (1)(d) or G.02.033(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 preventing a controlled drug 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 this Part; 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 and this Part.

Notice

(3) Before revoking an import permit, the Minister shall 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

G.02.044 If an import permit is revoked, the licensed dealer shall, as soon as feasible after its revocation, return the original of the permit to the Minister.

Export Permits

Application

G.02.045 (1) A licensed dealer shall submit to the Minister, before each exportation of a controlled drug, 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 controlled drug 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 controlled drug,
- (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, if any, and
- (iii) the strength per unit of the controlled drug in the product;
(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 shall

(a) be signed and dated by the qualified person in charge or the 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

Issuance

G.02.046 Subject to section G.02.049, on completion of the review of the export permit application, the Minister shall issue to the licensed dealer an export permit that contains

(a) the permit number;
(b) the information set out in paragraphs G.02.045(1)(a) to (f);
(c) the effective date of the permit;
(d) the expiry date of the permit, which shall be the earliest of
- (i) the 180th day after its effective date,
- (ii) the expiry date of the dealer's licence, and
- (iii) the expiry date of the import permit issued by a 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 potential risk to public health or safety, including the risk of a controlled drug being diverted to an illicit market or use.

Validity

G.02.047 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 G.02.052 or G.02.053,
(c) the date of the suspension or revocation of the dealer's licence under section G.02.032 or G.02.033, and
(d) the date of the expiry, suspension or revocation of the import permit that applies to the controlled drug to be exported and that is issued by the competent authority in the country of final destination.

Return of permit

G.02.048 If an export permit expires, the licensed dealer shall, as soon as feasible after its expiry, return the original of the permit to the Minister.

Refusal

G.02.049 (1) The Minister shall refuse to issue an export permit if

(a) the licensed dealer is not authorized by their dealer's licence to export the relevant controlled drug 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 G.02.045(3) or the information or documents that they have provided are not sufficient to complete the review of the 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 with the application;
(e) the licensed dealer has been notified that their application to renew or amend their licence is to 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 controlled drug being diverted to an illicit market or use.

Notice

(2) Before refusing to issue the permit, the Minister shall 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

G.02.050 The holder of an export permit shall provide a copy of the permit to the customs office at the time of exportation.

Declaration

G.02.051 The holder of an export permit shall provide the Minister, within 15 days after the day of export of the controlled drug 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 with respect to the controlled drug;
(b) with respect to the controlled drug,
- (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) in the case of the exportation of a product that contains the controlled drug,
- (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, if any, and
- (iii) the strength per unit of the controlled drug in the product; and
(d) the name of the customs office from which the controlled drug was exported and the date of export.

Suspension

G.02.052 (1) The Minister shall 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 the risk of a controlled drug 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 shall be carried out by the dealer and the date by which the dealer shall do so.

Reinstatement of permit

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

Revocation

G.02.053 (1) Subject to subsection (2), the Minister shall 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 G.02.052(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 with the application;
(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 controlled drug to an illicit market or use; or
(f) the dealer's licence has been revoked.

Exceptions

(2) The Minister shall not revoke an export permit for a ground set out in paragraph (1)(d) or G.02.033(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 preventing a controlled drug 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 this Part; 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 and this Part.

Notice

(3) Before revoking an export permit, the Minister shall 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

G.02.054 If an export permit is revoked, the licensed dealer shall, as soon as feasible after its revocation, return the original of the permit to the Minister.

Identification

Name

G.02.055 A licensed dealer must include its name, as set out in its dealer's licence, on all the means by which it identifies itself in relation to controlled drugs, including product labels, orders, shipping documents, invoices and advertising.

Sale and Provision of Controlled Drugs

Sale to licensed dealer

G.02.056 A licensed dealer may sell or provide a controlled drug to another licensed dealer.

Sale to pharmacist

G.02.057 (1) Subject to subsection (2), a licensed dealer may sell or provide a controlled drug to a pharmacist.

Exception — pharmacist named in a notice

(2) A licensed dealer shall not sell or provide to a pharmacist named in a notice issued under section G.03.017.2 the controlled drugs referred to in the notice.

Retraction

(3) Subsection (2) does not apply to a licensed dealer who has received a notice of retraction issued under section G.03.017.3 in respect of a pharmacist named in a notice issued under section G.03.017.2.

Sale to a practitioner

G.02.058 (1) Subject to subsections (2) and (3), a licensed dealer may sell or provide a controlled drug to a practitioner.

Midwife, nurse practitioner or podiatrist

(2) For the purpose of subsection (1) a licensed dealer may sell or provide a controlled drug to a midwife, nurse practitioner or podiatrist only if that practitioner is permitted to prescribe or possess the controlled drug, or to conduct an activity with it, in accordance with sections 3 and 4 of the New Classes of Practitioners Regulations.

Exception — practitioner named in a notice

(3) A licensed dealer shall not sell or provide to a practitioner who is named in a notice issued under section G.04.004.2 the controlled drugs referred to in the notice, unless the licensed dealer has received a notice of retraction issued under G.04.004.3.

Provision to hospital employee

G.02.059 A licensed dealer may provide a controlled drug to a hospital employee.

Sale to exempted person

G.02.060 A licensed dealer may sell or provide a controlled drug to a person who is exempted under section 56 of the Act with respect to the possession of that drug.

Written order

G.02.061 A licensed dealer may sell or provide a controlled drug under sections G.02.056 to G.02.060059 if

(a) the licensed dealer has received a written order that specifies the name and quantity of the drug to be supplied and is signed and dated
- (i) in the case of a drug 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 drug is to be sold or provided; and
(b) the licensed dealer has verified the signature, if it is unknown to them.

Verbal order

G.02.062 (1) A licensed dealer may sell or provide a controlled drug listed in Part II or III of the schedule to this Part if

(a) the licensed dealer has received a verbal order that specifies the name and quantity of the drug to be supplied; and
(b) in the case of the provision of the drug 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 who has received a verbal order from a pharmacist or practitioner shall, 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 controlled drug;
(b) the date the pharmacist or practitioner received the controlled drug; and
(c) the name and the quantity of the controlled drug.

No further sale without receipt

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

Anticipated multiple sales

G.02.063 (1) A licensed dealer may sell or provide a controlled drug more than once in respect of one order if the order indicates

(a) the number of sales or provisions, not exceeding four;
(b) the specific quantity for each sale or provision; and
(c) the intervals between each sale or provision.

Multiple sales — insufficient stock

(2) A licensed dealer may sell or provide a controlled drug more than once in respect of one order if 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 licensed dealer may sell or provide against the order the quantity of the drug that the licensed dealer has available and deliver the balance later.

Packaging and Transportation

Packaging — sale and provision

G.02.064 (1) A licensed dealer who sells or provides a controlled drug shall securely package it in its immediate container, which shall be sealed in such a manner that the container cannot be opened without breaking the seal.

Packaging — transport and export

(2) A licensed dealer who transports or exports a controlled drug shall 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 controlled drug and that has a registration number.

Transport

G.02.065 (1) A licensed dealer shall, in taking delivery of a controlled drug that they have imported or in making delivery of a controlled drug,

(a) take any measures that are necessary to ensure the security of the drug 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 drug as well as the signatures of any persons handling it until it is delivered to the consignee;
(c) in the case of an imported drug, ensure that it is transported directly to the site specified in their licence after it is released under the Customs Act; and
(d) in the case of a drug to be exported, transport it directly from the site specified in their licence to the customs office where it is to be exported.

Exception

(2) A licensed dealer may have a preparation transported by a common carrier.

Thefts, Losses and Suspicious Transactions

Protective measures

G.02.066 A licensed dealer shall take any measures that are necessary to ensure the security of any controlled drug in their possession and any licence or permit in their possession.

Theft or loss — licences and permits

G.02.067 A licensed dealer who becomes aware of a theft or loss of their licence or permit shall provide a written report to the Minister not later than 72 hours after becoming aware of the occurrence.

Theft or unexplainable loss — controlled drugs

G.02.068 A licensed dealer who becomes aware of a theft of a controlled drug or of a loss of a controlled drug that cannot be explained on the basis of normally accepted business activities shall

(a) provide a written report to a member of a police force not later than 24 hours after becoming aware of the occurrence; and
(b) provide a written report to the Minister not later than 72 hours after becoming aware of the occurrence and confirm that the report required under paragraph (a) has been provided.

Explainable loss — controlled drugs

G.02.069 A licensed dealer who becomes aware of a loss of a controlled drug that can be explained on the basis of normally accepted business activities shall provide a written report to the Minister not later than 10 days after becoming aware of the occurrence.

Suspicious transaction

G.02.070 (1) A licensed dealer shall provide a written report containing the following information to the Minister not later than 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 controlled drug to an illicit market or use:

(a) the 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 involved, including its date and time, its type, the name and quantity of the controlled drug and, in the case of a product or compound, the quantity of every controlled drug that it contains;
(d) in the case of a product that contains the controlled drug, other than a test kit, the drug identification number that is assigned to the product under section C.01.014.2; 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 shall 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

G.02.071 A report made under any of sections G.02.067 to G.02.070, 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

Destruction at site

G.02.072 (1) A licensed dealer who destroys a controlled drug at the site specified in their licence shall ensure that the following conditions are met:

(a) the licensed dealer obtains the prior approval of the Minister to carry out the destruction;
(b) the destruction occurs in the presence of two of the following persons, at least one of whom shall be a person referred to in subparagraph (i):
- (i) the senior person in charge, the qualified person in charge or the 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 conducted in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
(d) once the destruction is completed, the person carrying 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 controlled drug was completely destroyed, to which each signatory shall add their name in printed letters.

Destruction elsewhere than at site

(2) A licensed dealer who destroys a controlled drug elsewhere than at the site specified in their licence shall ensure that the following conditions are met:

(a) the licensed dealer obtains the prior approval of the Minister to carry out the destruction;
(b) the licensed dealer takes appropriate measures to ensure the security of the controlled drug while it is being transported in order to prevent the diversion of it 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 conducted in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
(e) once the destruction is completed, the person carrying out the destruction provides the licensed dealer with a dated declaration attesting that the controlled drug was completely destroyed and containing
- (i) the municipal address of the place of destruction,
- (ii) the name and quantity of the controlled drug 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 approval

G.02.073 (1) A licensed dealer shall submit to the Minister an application that contains the following information in order to obtain the Minister's prior approval to destroy a controlled drug:

(a) their name, municipal address and dealer'slicence 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 parargraph G.02.072(1)(b) and information establishing that they meet the conditions of that paragraph;
(f) the name of the controlled drug to be destroyed 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 controlled drug to be destroyed or the product or compound containing it and, if applicable, its strength per unit, the number of units per package and the number of packages.

Signature and attestation

(2) The application shall

(a) be signed and dated by the qualified person in charge or the alternate qualified person in charge; and
(b) include an attestation by that person that
- (i) the proposed method of destruction complies with all applicable 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

Approval

G.02.074 On completion of the review of the application, the Minister shall approve the destruction of the controlled drug 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 G.02.072(1)(b) do not meet the conditions of that paragraph;
(b) the Minister has reasonable grounds to believe that the controlled drug 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 with the application;
(d) the controlled drug or a portion of it is required for the purposes of a criminal or administrative investigation or any preliminary inquiry, trial or other proceeding under any Act or its regulations; or
(e) the Minister has reasonable grounds to believe that the approval of the destruction would likely create a risk to public health or safety, including the risk of the controlled drug being diverted to an illicit market or use.

Documents

Method of recording information

G.02.075 A licensed dealer shall record any information that they are required to record under this Part using a method that permits an audit of it to be made at any time.

Information — general

G.02.076 A licensed dealer shall record the following information:

(a) the name and quantity of any controlled drug 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 and quantity of any controlled drug 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 controlled drug that the dealer sells or provides,
- (i) the brand name of the product or the name of the compound containing the controlled drug and the name of the controlled drug,
- (ii) the quantity and, if applicable, the strength per unit of the controlled drug,
- (iii) the name and municipal address of the person to whom it was sold or provided, and
- (iv) the date on which it was sold or provided;
(d) the name and quantity of any controlled drug 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 controlled drug, the number of units per package and the number of packages;
(e) the name and quantity of any controlled drug used 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 and quantity of any controlled drug in stock at the end of each month;
(g) the name and the quantity of any controlled drug 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) in the case of an importation, the name and quantity of any controlled drug imported, 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) in the case of an exportation, the name and quantity of any controlled drug exported, 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 orders

G.02.077 A licensed dealer who receives a verbal order for a controlled drug listed in Part II or III of the schedule to this Part and sells or provides it to a pharmacist, a practitioner or a hospital employee shall 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.

Destruction

G.02.078 A licensed dealer shall record the following information concerning any controlled drug that they destroy at the site specified in their licence:

(a) the municipal address of the place of destruction;
(b) the name and quantity of the controlled drug and, if applicable, the brand name and quantity of the product containing the drug or the name and quantity of the compound containing the drug;
(c) the method of destruction; and
(d) the date of destruction.

Annual report

G.02.079 (1) Subject to subsections (2) and (3), a licensed dealer shall provide to the Minister, within three months after the end of each calendar year, an annual report that contains

(a) the name and total quantity of each controlled drug that they receive, produce, use to produce a product or compound, sell, provide, import, export or destroy during the calendar year;
(b) the quantity of each controlled drug in physical inventory taken at the site specified in their licence at the end of the calendar year; and
(c) the name and quantity of any controlled drug that has been lost in the course of conducting activities during the calendar year.

Non-renewal or revocation within first three months

(2) A licensed dealer whose licence expires without being renewed or is revoked within the first three months of a calendar year shall 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 months 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) A licensed dealer whose licence expires without being renewed or is revoked after the first three months of a calendar year shall 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, including the quantity in physical inventory on the date of expiry or revocation.

Retention of documents

G.02.080 (1) A licensed dealer or former licensed dealer shall keep any document containing the information that they are required to record under this Part, including every declaration and a copy of every report, for a two-year period beginning on after 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 any time.

Location

(2) The documents shall 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

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

2 Paragraphs G.03.002.1(c) and (d) of the French version of the Regulations are replaced by the following:

c) dispenser, vendre ou fournir une drogue contrôlée, autre qu'une préparation, soit à un praticien, soit en vertu d'une ordonnance ou d'une commande faite par un praticien nommé dans un avis communiqué par le ministre selon l'article G.04.004.2;
d) dispenser, vendre ou fournir une préparation, soit à un praticien, soit en vertu d'une ordonnance ou d'une commande faite par un praticien nommé dans un avis communiqué par le ministre selon l'article G.04.004.2.

3 Section G.03.005 of the Regulations is replaced by the following:

G.03.005 A pharmacist may provide a controlled drug to a hospital employee or to a practitioner in a hospital on receipt of a written order signed and dated 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, if the signature of that pharmacist or practitioner is known to the pharmacist or, if unknown, has been verified.

4 Sections G.03.007 to G.03.009 of the Regulations are replaced by the following:

G.03.007 If, in accordance with a written order or prescription, a pharmacist dispenses a controlled drug listed in Part I of the schedule to this Part, other than a preparation, the pharmacist shall immediately enter in a book, register or similar 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, quantity and form of the controlled drug dispensed;
(e) the date on which the controlled drug was dispensed; and
(f) the number assigned to the order or prescription.

G.03.008 A pharmacist shall, before dispensing a controlled drug 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) the name, quantity and form of the controlled drug;
(e) the directions for use given with the order or prescription;
(f) the date on which the controlled drug was dispensed; and
(g) the number assigned to the order or prescription.

G.03.009 A pharmacist shall maintain a special prescription file in which shall be filed in sequence as to date and number all written orders or prescriptions for controlled drugs dispensed and the written record of all controlled drugs dispensed in accordance with a verbal order or prescription.

5 Paragraphs G.03.014(c) and (d) of the Regulations are replaced by the following:

(c) the Minister, sell or provide to the Minister any quantity of that drug, specified in the order, that is required by the Minister in connection with his or her duties; and
(d) a person exempted under section 56 of the Act with respect to that controlled drug, sell or provide to that person any quantity of that drug that is specified in the order.

6 Section G.03.017 of the Regulations is replaced by the following:

G.03.017 The Minister shall provide in writing any factual information about a pharmacist that has been obtained under the Act or this Part 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 pharmacist is or was registered and 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 this Part; or
(b) in a province in which the pharmacist is not registered and 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.

7 (1) Paragraph G.03.017.2(2)(c) of the Regulations is replaced by the following:

(c) been convicted of a designated substance offence or of an offence under this Part.

(2) Paragraph G.03.017.2(3)(c) of the Regulations is replaced by the following:

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

(3) Paragraph G.03.017.2(5)(a) of the Regulations is replaced by the following:

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

(4) Subparagraph G.03.017.2(5)(c)(ii) of the Regulations is replaced by the following:

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

8 Subparagraph G.03.017.3(b)(ii) of the Regulations is replaced by the following:

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

9 Section G.04.001 of the Regulations is replaced by the following:

G.04.001 (1) The following definitions apply in this section.

administer includes to prescribe, sell or provide a drug. (administrer)

designated drug means any of the following controlled drugs:

(a) amphetamine and its salts;
(b) benzphetamine and its salts;
(c) methamphetamine and its salts;
(d) phenmetrazine and its salts; or
(e) phendimetrazine and its salts. (drogue désignée)

(2) Subject to subsections (3) and (4) and to an exemption granted under section 56 of the Act with respect to the administration of the controlled drug specified in the exemption, no practitioner shall administer a controlled drug to any person or animal.

(3) A practitioner may administer a controlled drug, other than a designated drug, to a person or to an animal, if

(a) that person or animal is a patient under their professional treatment; and
(b) the controlled drug is required for the condition for which the patient is receiving treatment.

(4) A practitioner of medicine, dentistry or veterinary medicine or a nurse practitioner may administer a designated drug to a person or animal who is a patient under their professional treatment if the designated drug is for the treatment of any of the following conditions:

(a) in the case of persons,
- (i) narcolepsy,
- (ii) hyperkinetic disorders in children,
- (iii) epilepsy,
- (iv) parkinsonism, or
- (v) hypotensive states associated with anesthesia; or
(b) in the case of animals, depression of cardiac and respiratory centres.

10 Paragraphs G.04.002(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 controlled drug; or
(b) three times the generally recognized maximum daily therapeutic dosage for that controlled drug if the manufacturer or assembler has not recommended a maximum daily dosage.

11 Section G.04.004 of the Regulations is replaced by the following:

G.04.004 The Minister shall provide in writing any factual information about a practitioner that has been obtained under the Act or this Part to the provincial professional licensing authority 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 this Part; 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.

12 (1) Paragraph G.04.004.2(2)(c) of the Regulations is replaced by the following:

(c) been convicted of a designated substance offence or of an offence under this Part.

(2) Paragraphs G.04.004.2(3)(b) and (c) of the Regulations are replaced by the following:

(b) all pharmacies within the province in which the practitioner is registered and practising;
(c) the provincial professional licensing authority of the province in which the practitioner is registered and entitled to practise;

(3) Paragraph G.04.004.2(3)(e) of the Regulations is replaced by the following:

(e) all pharmacies in an adjacent province in which a prescription or order from the practitioner may be filled.

(4) Paragraphs G.04.004.2(4)(b) to (e) of the Regulations are replaced by the following:

(b) has, on more than one occasion, self-administered a controlled drug, other than a preparation, 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 preparation, 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 controlled drug, other than a preparation, 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 preparation 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

(5) Paragraph G.04.004.2(5)(a) of the Regulations is replaced by the following:

(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;

(6) Subparagraph G.04.004.2(5)(c)(ii) of the Regulations is replaced by the following:

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

13 Subparagraph G.04.004.3(b)(ii) of the Regulations is replaced by the following:

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

14 Paragraph G.05.001(1)(d) of the French version of the Regulations is replaced by the following:

d) le nom du malade pour lequel cette drogue a été dispensée;

15 Divisions 6 and 7 of Part G of the Regulations are replaced by the following:

DIVISION 6

General

Labelling — drug dispensed in accordance with prescription

G.06.001 In the case of a controlled drug that is dispensed by a pharmacist in accordance with a prescription, section C.01.004 does not apply but the label of the package in which the controlled drug is contained shall include the following:

(a) the name and municipal address of the pharmacy or pharmacist;
(b) the date and number of the prescription;
(c) the name of the person for whom the controlled drug is dispensed;
(d) the name of the practitioner;
(e) directions for use; and
(f) any other information that the prescription requires be shown on the label.

Labelling — test kit

G.06.002 Section C.01.004 does not apply to a test kit that contains a controlled drug and that has a registration number.

Provision for identification or analysis

G.06.003 (1) Despite anything in this Part, a person may, for the purpose of identification or analysis of a controlled drug, provide or deliver the drug to

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

Agent or mandatary of practitioner of medicine

(2) An agent or mandatary of a practitioner of medicine who receives the controlled drug shall immediately provide or deliver it to

(a) the practitioner whom they represent; or
(b) the Minister.

Practitioner of medicine

(3) A practitioner of medicine who receives the controlled drug shall immediately provide or deliver it

(a) for the purpose of its identification or analysis, to a person exempted under section 56 of the Act with respect to the possession of that drug for that purpose; or
(b) to the Minister.

Advertising

G.06.004 No person shall

(a) advertise a controlled drug to the general public; or
(b) publish any written advertisement respecting a controlled drug unless that advertisement displays the following symbol in a clear and conspicuous colour and size in the upper left quarter of its first page:

Advertising

Records — exempted person

G.06.005 Every person who is exempted under section 56 of the Act with respect to the possession or administration of a controlled drug and every practitioner of medicine who has received a controlled drug under subsection G.06.003(1) or (2) and every agent or mandatary of a practitioner of medicine who has received a controlled drug under subsection G.06.003(1) shall

(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 controlled drug 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 controlled drug was purchased or received, and
- (iii) details of the use of the controlled drug;
(b) provide any information respecting those controlled drugs that the Minister may require; and
(c) permit access to the records required to be kept by this Part.

Communication by Minister

G.06.006 (1) The following definitions apply in this section.

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

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)

Nurses

(2) The Minister may provide to a nursing statutory body any information concerning any member of that body obtained under this Part, the Act or the Food and Drugs Act.

Non-application

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

Notification of application for order of restoration

G.06.007 (1) For the purpose of subsection 24(1) of the Act, notification of an application for an order of restoration shall be given in writing to the Attorney General by registered mail and shall be mailed not less than 15 days before the date on which the application is to be made to a justice.

Content of notification

(2) The notification shall 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 controlled drug 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 controlled drug or other thing referred to in paragraph (c).

16 The schedule to Part G of the Regulations is amended by replacing the references after the heading "SCHEDULE" with the following:

(Sections G.01.001 and G.01.002, subsections G.01.005(1) and G.02.062(1), section G.02.077., subsection G.03.001(3), paragraph G.03.006(a), section G.03.007 and subsection G.05.001(4))

17 The heading "General" before section J.01.001 and sections J.0.001 to J.01.036 of the Regulations are replaced by the following:

Definitions

Definitions

J.01.001 The following definitions apply in this Part.

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

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 restricted drugs into or from the country. (autorité compétente)

compound includes a preparation. (composé)

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

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)

institution means any institution engaged in research on drugs and includes a hospital, a university in Canada, a department or agency of the Government of Canada or of a government of a province or any part of it. (établissement)

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

label has the same meaning as in section 2 of the Food and Drugs Act. (étiquette)

licensed dealer means the holder of a licence issued under section J.01.015. (distributeur autorisé)

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

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

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

proper name with reference to a restricted drug means the name in English or French

(a) assigned to the drug in section C.01.002;
(b) that appears in bold face type for the drug in these Regulations and, if the drug is dispensed in a form other than that described in Part C, the name of the dispensing form; or
(c) assigned in any of the publications mentioned in Schedule B to the Food and Drugs Act in the case of a drug not included in paragraph (a) or (b). (nom propre)

qualified investigator means, in respect of a restricted drug, a person whose use and possession of that drug is authorized by the Minister under subsection J.01.064(4) and who is

(a) employed by or connected with an institution; or
(b) engaged in clinical testing or laboratory research in an institution in respect of that drug. (chercheur compétent)

qualified person in charge means the individual designated under subsection J.01.012(1). (responsable qualifié)

restricted drug means

(a) a controlled substance that is set out in the schedule to this Part; and
(b) cocaine (benzoylmethylecgonine) or any of its salts, or a product or compound that contains such a substance, except
- (i) a drug in dosage form, as defined in subsection C.01.005(3), that has a drug identification number assigned to it under Division 1 of Part C or that is authorized for sale under Division 5 of Part C, and
- (ii) cocaine (benzoylmethylecgonine) or any of its salts, or a preparation that contains such a substance, that is prepared by a pharmacist in accordance with or in anticipation of a prescription. (drogue d'usage restreint)

senior person in charge means the individual designated under section J.01.011. (responsable principal)

test kit means a kit

(a) that contains a restricted drug and a reagent system or buffering agent;
(b) that is designed to be used during the course of a chemical or analytical procedure to test for the presence or quantity of a restricted drug 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)

General

Temporary accelerated scheduling

J.01.002 (1) The Minister may, by order, add to column 1 of Part III of the schedule to this Part any item or portion of an item listed in Schedule V to the Act for a period referred to in column 2 that is the same as that listed in Schedule V for that item.

Deletion from Part III of schedule

(2) The Minister may, by order, delete any item or portion of an item from column 1 of Part III of the schedule to this Part.

Deletion — Schedule V to Act

(3) An item or portion of an item listed in Part III of the schedule to this Part is deemed to be deleted on the day it is no longer listed in Schedule V to the Act.

Non-application — police force

J.01.003 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 this Part.

Possession

Authorized persons

J.01.004 (1) The following persons are authorized to possess a restricted drug listed in Part I of the schedule to this Part or referred to in paragraph (b) of the definition restricted drug in section J.01.001:

(a) a licensed dealer;
(b) a qualified investigator who possesses the drug in connection with clinical testing or laboratory research in an institution;
(c) an analyst, inspector, member of the Royal Canadian Mounted Police, constable, peace officer, member of the staff of the Department of Health or officer of a court, who possesses the drug in connection with their employment; and
(d) a person exempted under section 56 of the Act with respect to the possession of that drug.

Agent or mandatary

(2) A person is authorized to possess a restricted drug listed in Part I of the schedule to this Part or referred to in paragraph (b) of the definition restricted drug in section J.01.001 if they are acting as the agent or mandatary of a person referred to in paragraph (1)(a), (b) or (d).

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

(3) A person is authorized to possess a restricted drug listed in Part I of the schedule to this Part or referred to in paragraph (b) of the definition restricted drug in section J.01.001 if they

(a) are acting as the agent or mandatary of a person that they have reasonable grounds to believe is a person referred to in paragraph (1)(c); and
(b) possess the restricted drug for the purpose of assisting that person in the administration or enforcement of an Act or regulation.

Test Kits

Authorized activities

J.01.005 A person may sell, possess or otherwise deal in a test kit if

(a) a registration number has been issued for the test kit under section J.01.007 and has not been cancelled under section J.01.008;
(b) the test kit bears, on its external surface,
- (i) the name of the manufacturer,
- (ii) the trade name or trademark, and
- (iii) the registration number; and
(c) the test kit is sold, possessed or otherwise dealt in for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose.

Application for registration number

J.01.006 (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 restricted drug 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 shall

(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 shall provide the Minister with any information or document that the Minister determines is necessary to complete the Minister's review of the application, not later than the date specified in the Minister's written request to that effect.

Issuance of registration number

J.01.007 On completion of the review of the application for a registration number, the Minister shall issue a registration number for the test kit, preceded by the letters "TK", if the Minister is satisfied 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 restricted drug 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 any restricted drug as to have no significant drug abuse potential.

Cancellation of registration number

J.01.008 The Minister shall 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 preventing a restricted drug from being diverted to an illicit market or use.

Licensed Dealers

Authorized Activities

General

J.01.009 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a restricted drug if they comply with

(a) the terms and conditions of their dealer's licence and any permit issued under this Part; and
(b) this Part.

Qualified person in charge present

(2) A licensed dealer may conduct an activity in relation to a restricted drug 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 shall obtain a permit to import or export a restricted drug.

Possession for export

(4) A licensed dealer may possess a restricted drug for the purpose of exporting it if they have obtained it in accordance with this Part.

Licences

Preliminary Requirements

Eligible persons

J.01.010 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 restricted drugs 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

J.01.011 An applicant for a dealer's licence shall designate only one individual as the senior person in charge, who may be the applicant if they are an individual, who has overall responsibility for management of the activities with respect to restricted drugs specified in the licence application.

Qualified person in charge

J.01.012 (1) An applicant for a dealer's licence shall designate only one individual as the qualified person in charge, who may be the applicant if they are an individual, who is responsible for supervising the activities with respect to restricted drugs that are specified in the licence application and for ensuring that those activities comply with this Part.

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 may be the applicant if they are an individual, who is authorized to replace the qualified person in charge when that person is absent.

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 are
- (i) a person registered 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) the holder of 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) the holder of 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 restricted drugs specified in the licence to properly carry out their duties; and
(d) they have sufficient knowledge of the provisions of the Act and this Part that are applicable to the activities specified in the 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

J.01.013 A person 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, the person
- (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,
- (i) the person was convicted as an adult, or
- (ii) if they committed the offence when they were at least 14 years old but not less than 18 years old, the person 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.

Application, Issuance, Validity and Refusal

Application

J.01.014 (1) A person who intends to conduct an activity referred to in section J.01.009 shall obtain a dealer's licence for each site at which they plan 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 mentioned in paragraph J.01.010(c), the applicant's name and the title of the position;
(b) the municipal address, telephone number and, if applicable, the facsimile number and email address of the proposed site and, if different from the municipal address, its mailing address;
(c) the name and date of birth of the senior person in charge;
(d) with respect to the proposed qualified person in charge and the proposed alternate qualified person in charge,
- (i) their name and date of birth,
- (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 name of their profession that is relevant to their duties, the name of the province that authorizes them to practise it and their authorization number,
- (v) their education, training and work experience relevant to their duties, and
- (vi) their hours of work at the site;
(e) the activities that are to be conducted and the restricted drugs 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 restricted drug, 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 name and the strength per unit of the restricted drug in it,
- (iii) its quantity or package sizes,
- (iv) if it is to be manufactured or assembled by or for another licensed dealer under a custom order, the name, municipal address and dealer's licence number of the other licensed dealer, and
- (v) if the applicant's name appears on the label of the product or compound, a copy of the inner label;
(g) if the licence is requested to produce a restricted drug other than a product or compound that contains a restricted drug,
- (i) its name,
- (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 any activity that is not described in paragraphs (f) and (g), the name of the restricted drug 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 J.01.078.

Documents

(2) An application for a dealer's licence shall 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 senior person in charge, the proposed qualified person in charge and the proposed alternate qualified person in charge, attesting that the person is not ineligible for a reason specified in section J.01.013;
(c) a document issued by a Canadian police force in relation to each person referred to in paragraph (b), indicating whether, during the 10 years before the day on which the application is submitted, the person was convicted as specified in subparagraph J.01.013(a)(i) or received a sentence as specified in subparagraph J.01.013(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 J.01.013(b)(i) or received a sentence as specified in subparagraph J.01.013(b)(ii);
(e) a declaration, signed and dated by the senior person in charge, attesting that the proposed qualified person in charge and the proposed alternate qualified person in charge have the knowledge and experience required under paragraphs J.01.012(3)(c) and (d); and
(f) if the proposed qualified person in charge or the proposed alternate qualified person in charge does not meet the requirement of subparagraph J.01.012(3)(b)(i), either
- (i) a copy of the person's diploma, certificate or credential referred to in subparagraph J.01.012(3)(b)(ii) or (iii) and a copy of the course transcript for it, or
- (ii) a detailed description of the education, training or work experience that is required under paragraph J.01.012(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) An application for a dealer's licence shall

(a) be signed and dated by the senior person in charge; and
(b) include an attestation by the senior person in charge that
- (i) all 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 shall provide the Minister with any information or document that the Minister determines is necessary to complete the Minister's review of the application, not later than the date specified in the Minister's written request to that effect.

Issuance

J.01.015 Subject to section J.01.018, on completion of the review of the licence application, the Minister shall 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 restricted drugs in respect of which each activity may be conducted;
(d) the municipal address of the site at which the licensed 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 shall be not later than the third anniversary of 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 potential risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use; and
(i) if the licensed dealer produces a restricted drug, the quantity that they may produce and the authorized production period.

Validity

J.01.016 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 J.01.040 or J.01.041.

Return of licence

J.01.017 A licensed dealer whose licence is not renewed shall return the original of the licence to the Minister as soon as feasible after its expiry.

Refusal

J.01.018 (1) The Minister shall refuse to issue a dealer's licence if

(a) the applicant is not eligible under section J.01.010;
(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 or its regulations, or
- (ii) a term or condition of a licence or permit issued to the applicant under any regulations made under the Act;
(c) during the 10 years before the day on which the licence application is submitted, the senior person in charge, the proposed qualified person in charge or the proposed alternate qualified person in charge was convicted as specified in subparagraph J.01.013(a)(i) or (b)(i) or received a sentence as specified in subparagraph J.01.013(a)(ii) or (b)(ii);
(d) an activity for which the licence is requested would contravene an international obligation;
(e) the applicant does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the licence is requested;
(f) the method referred to in paragraph J.01.014(1)(j) does not permit the recording of information as required under section J.01.078;
(g) the applicant has not complied with the requirements of subsection J.01.014(4) or the information and documents that they have provided are not sufficient to complete the review of the application;
(h) the Minister has reasonable grounds to believe that the applicant has submitted false or misleading information or false or falsified documents in or with the application;
(i) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the applicant has been involved in the diversion of a restricted drug to an illicit market or use or has been involved in an activity that contravened an international obligation; or
(j) the Minister has reasonable grounds to believe that the issuance of the licence would likely create a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

Exceptions

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

(a) the applicant does not have a history of non-compliance with the Act or its 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 and this Part.

Notice

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

Renewal

Application

J.01.019 (1) To apply to renew a dealer's licence, a licensed dealer shall submit to the Minister an application that contains the information and documents referred to in subsections J.01.014(1) and (2).

Signature and attestation

(2) An application shall

(a) be signed and dated by the senior person in charge of the site to which the renewed licence would apply; and
(b) include an attestation by the senior person in charge 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

Renewal

J.01.020 (1) Subject to section J.01.023, on completion of the review of the renewal application, the Minister shall issue a renewed dealer's licence that contains the information specified in section J.01.015.

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 potential risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

Validity

J.01.021 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 J.01.040 or J.01.041.

Return of previous licence

J.01.022 The licensed dealer shall, as soon as feasible after the effective date of the renewal, return the original of the previous licence to the Minister.

Refusal

J.01.023 (1) The Minister shall refuse to renew a dealer's licence if

(a) the licensed dealer is no longer eligible under section J.01.010;
(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 or this Part, or
- (ii) a term or condition of a licence or permit issued to the dealer under this Part;
(c) during the 10 years before the day on which the renewal application is submitted, the senior person in charge, the proposed qualified person in charge or the proposed alternate qualified person in charge was convicted as specified in subparagraph J.01.013(a)(i) or (b)(i) or received a sentence as specified in subparagraph J.01.013(a)(ii ) or (b)(ii);
(d) an activity for which the renewal is requested would contravene an international obligation;
(e) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the renewal is requested;
(f) the method referred to in paragraph J.01.014(1)(j) does not permit the recording of information as required under section J.01.078;
(g) the licensed dealer has not complied with the requirements of subsection J.01.019(3) or the information or documents that they have provided are not sufficient to complete the review of the application;
(h) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or with the application;
(i) information received from a competent authority or the United Nations gives the Minister reasonable grounds to believe that the licensed dealer has been involved in the diversion of a restricted drug to an illicit market or use or has been involved in an activity that contravened an international obligation; or
(j) the Minister has reasonable grounds to believe that the renewal of the licence would likely create a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

Exceptions

(2) The Minister shall not refuse to renew a licence under paragraph (1)(b) or (h) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including preventing a restricted drug 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 this Part; 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 and this Part.

Notice

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

Amendment

Application

J.01.024 (1) Before making a change affecting any information referred to in section J.01.015 that is contained in their dealer's licence, a licensed dealer shall 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 J.01.014 that are relevant to the proposed amendment.

Signature and attestation

(2) The application shall

(a) be signed and dated by the senior person in charge of the site to which the amended dealer's licence would apply; and
(b) include an attestation by the senior person in charge 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

Amendment

J.01.025 (1) Subject to section J.01.028, on completion of the review of the application, the Minister shall amend the dealer's licence.

Terms and conditions

(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 amendment; or
(c) reduce a potential risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

Validity

J.01.026 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 J.01.040 or J.01.041.

Return of previous licence

J.01.027 The licensed dealer shall, as soon as feasible after the effective date of the amendment, return the original of the previous licence to the Minister.

Refusal

J.01.028 (1) The Minister shall refuse to amend a dealer's licence if

(a) an activity for which the licence amendment is requested would contravene an international obligation;
(b) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the licence amendment is requested;
(c) the method referred to in paragraph J.01.014(1)(j) does not permit the recording of information as required by section J.01.078;
(d) the licensed dealer has not complied with the requirements of subsection J.01.024(3) or the information or documents that they have provided are not sufficient to complete the review of the 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 with the application; or
(f) the Minister has reasonable grounds to believe that the amendment of the licence would likely create a risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

Exception

(2) The Minister shall not refuse to amend a licence under paragraph (1)(e) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including preventing a restricted drug 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 this Part; 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 and this Part.

Notice

(3) Before refusing to amend a licence, the Minister shall 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

Application

J.01.029 (1) A licensed dealer shall 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 shall provide the Minister with the following with respect to any change referred to in any of subsection (1):

(a) details regarding the change affecting security measures in place at the site specified in the dealer's licence;
(b) in the case of the senior person in charge,
- (i) the information specified in paragraph J.01.014(1)(c), and
- (ii) the declaration specified in paragraph J.01.014(2)(b) and the documents specified in paragraphs J.01.014(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 J.01.014(1)(d), and
- (ii) the declarations specified in paragraphs J.01.014(2)(b) and (e) and the documents specified in paragraphs J.01.014(2)(c), (d) and (f).

Additional information and documents

Approval

J.01.030 (1) Subject to section J.01.031, on completion of the review of the application, the Minister shall approve the change.

Terms and conditions

(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 potential risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

Refusal

J.01.031 (1) The Minister shall refuse to approve the change if

(a) during the 10 years before the day on which the application is submitted, the proposed senior person in charge, qualified person in charge or alternate qualified person in charge was convicted as specified in subparagraph J.01.013(a)(i) or (b)(i) or received a sentence as specified in subparagraph J.01.0013(a)(ii) or (b)(ii);
(b) the licensed dealer has not complied with the requirements of subsection J.01.029(3) or the information or documents that they have provided are not sufficient to complete the review of the application;
(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 with the application; 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 restricted drug being diverted to an illicit market or use.

Exception

(2) The Minister shall 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 and this Part, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including preventing a restricted drug from being diverted to an illicit market or use.

Notice

Changes Requiring Notice

Prior notice

J.01.032 (1) A licensed dealer shall notify the Minister in writing before

(a) making or assembling a product or compound that is not set out in the most recent version of the list referred to in paragraph J.01.014(1)(f) that the licensed dealer has 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 set out in the list.

Information and list

(2) The notice shall contain the information referred to in paragraph J.01.014(1)(f) that is necessary to update the list and shall be accompanied by the revised version of the list.

Notice as soon as feasible

J.01.033 A licensed dealer shall notify the Minister in writing as soon as feasible of

(a) a change at the site at which a restricted drug is produced, assembled or stored; and
(b) a change to the processes used to conduct those activities and the conditions under which they are conducted.

Notice — next business day

J.01.034 A licensed dealer shall notify the Minister in writing, not later than the next business day after the change, that a person is no longer acting as the qualified person in charge or an alternate qualified person in charge.

Notice — 10 days

J.01.035 (1) A licensed dealer shall notify the Minister in writing not later than 10 days after one of the following changes occurs:

(a) a person is no longer acting 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 J.01.014(1)(f) that the licensed dealer has submitted to the Minister.

Information and list

(2) A notice submitted under paragraph (1)(b) shall specify which information referred to in paragraph J.01.014(1)(f) is being changed and shall be accompanied by the revised version of the list.

Notice of cessation of activities

J.01.036 (1) A licensed dealer who intends to cease conducting activities at their site — whether before or on the expiry of their licence — shall notify the Minister in writing to that effect at least 30 days before ceasing those activities.

Content of notice

(2) The notice shall 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 restricted drugs on the site as of that date will be dealt with by the licensed dealer, including
- (i) if some or all of them will be sold or provided to another licensed dealer who 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 who 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 facsimile number and email address of a person whom the Minister may contact for further information after activities have ceased.

Update

Changes to Terms and Conditions

Adding or modifying term or condition

J.01.037 (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 potential risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

Notice

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 preventing a restricted drug from being diverted to an illicit market or use.

Urgent circumstances — notice

(4) The addition or modification of a term or condition of a licence 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 shall be carried out by the dealer and the date by which the dealer shall do so.

Deletion of a term or condition

J.01.038 (1) The Minister may delete a term or condition of a licence of a licensed dealer if the Minister determines that it is no longer necessary.

Notice

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

Return of previous licence

J.01.039 The licensed dealer shall, as soon as feasible after the effective date of the addition, modification or deletion of a term or condition, return the original of the previous licence to the Minister.

Suspension and Revocation

Suspension

J.01.040 (1) The Minister shall 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 preventing a restricted drug 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 shall be carried out by the dealer and the date by which the dealer shall do so.

Reinstatement of licence

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

Revocation

J.01.041 (1) Subject to subsection (2), the Minister shall revoke a dealer's licence if

(a) the licensed dealer is no longer eligible under section J.01.010;
(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 or this Part, or
- (ii) a term or condition of a licence or permit issued to the dealer under this Part;
(f) during the 10 years before the day on which the licence is revoked, the senior person in charge, the qualified person in charge or the alternate qualified person in charge was convicted as specified in subparagraph J.01.013(a)(i) or (b)(i) or received a sentence as specified in subparagraph J.01.013(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 with the application; 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 restricted drug to an illicit market or use.

Exceptions

(2) The Minister shall 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 preventing a restricted drug 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 this Part; 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 and this Part.

Notice

(3) Before revoking a licence, the Minister shall 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

J.01.042 The licensed dealer shall, as soon as feasible after the effective date of the revocation, return the original of the licence to the Minister.

Import Permits

Application

J.01.043 (1) A licensed dealer shall submit to the Minister, before each importation of a restricted drug, 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 restricted drug 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) in the case of the importation of a product that contains the restricted drug,
- (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, if any, and
- (iii) the strength per unit of the restricted drug in the product;
(d) the name and municipal address, in the country of export, of the exporter from whom the restricted drug is being obtained;
(e) the name of the customs office where the importation is anticipated; and
(f) each proposed mode of transportation to be used and any proposed country of transit or transhipment.

Signature and attestation

(2) The application shall

(a) be signed and dated by the qualified person in charge or the 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

Issuance

J.01.044 Subject to section J.01.047, on completion of the review of the import permit application, the Minister shall issue to the licensed dealer an import permit that contains

(a) the permit number;
(b) the information set out in subsection J.01.043(1);
(c) the effective date of the permit;
(d) the expiry date of the permit, which shall be the 180th day after its effective date or, if it is earlier, 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 potential risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

Validity

J.01.045 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 J.01.050 or J.01.051,
(c) the date of the suspension or revocation of the dealer's licence under section J.01.040 or J.01.041, and
(d) the date of the expiry, suspension or revocation of the export permit that applies to the restricted drug to be imported and that is issued by the competent authority in the country of export.

Return of permit

J.01.046 If an import permit expires, the licensed dealer shall, as soon as feasible after its expiry, return the original of the permit to the Minister.

Refusal

J.01.047 (1) The Minister shall refuse to issue an import permit if

(a) the licensed dealer is not authorized by their dealer's licence to import the relevant restricted drug or their dealer's 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 J.01.043(3) or the information or documents that they have provided are not sufficient to complete the review of the 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 with the application;
(f) the licensed dealer has been notified that their application to renew or amend their licence is to 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 restricted drug being diverted to an illicit market or use.

Notice

(2) Before refusing to issue the permit, the Minister shall 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

J.01.048 The holder of an import permit shall provide a copy of the permit to the customs office at the time of importation.

Declaration

J.01.049 The holder of an import permit shall provide the Minister, within 15 days after the day of release of the restricted drug 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 with respect to the restricted drug;
(b) with respect to the restricted drug,
- (i) its name, as specified in the dealer's licence,
- (ii) if it is a salt, the name of the salt, and
- (ii) its quantity,
(c) in the case of the importation of a product that contains the restricted drug,
- (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, if any, and
- (iii) the strength per unit of the restricted drug in the product; and
(d) the name of the customs office from which the restricted drug was released and the date of the release.

Suspension

J.01.050 (1) The Minister shall 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 the risk of a restricted drug 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 shall be carried out by the dealer and the date by which the dealer shall do so.

Reinstatement of permit

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

Revocation

J.01.051 (1) Subject to subsection (2), the Minister shall 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 J.01.050(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 with the application;
(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 restricted drug to an illicit market or use; or
(f) the dealer's licence has been revoked.

Exceptions

(2) The Minister shall not revoke an import permit for a ground set out in paragraph (1)(e) or J.01.041(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 preventing a restricted drug 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 this Part; 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 and this Part.

Notice

(3) Before revoking an import permit, the Minister shall 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

J.01.052 If an import permit is revoked, the licensed dealer shall, as soon as feasible after its revocation, return the original of the permit to the Minister.

Export Permits

Application

J.01.053 (1) A licensed dealer shall submit to the Minister, before each exportation of a restricted drug, 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 restricted drug 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 restricted drug,
- (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, if any, and
- (iii) the strength per unit of the restricted drug in the product;
(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 shall

(a) be signed and dated by the qualified person in charge or the 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

Issuance

J.01.054 Subject to section J.01.057, on completion of the review of the export permit application, the Minister shall issue to the licensed dealer an export permit that contains

(a) the permit number;
(b) the information set out in paragraphs J.01.053(1)(a) to (f);
(c) the effective date of the permit;
(d) the expiry date of the permit, which shall be the earliest of
- (i) the 180th day after its effective date,
- (ii) the expiry date of the dealer's licence, and
- (iii) the expiry date of the import permit issued by a 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 potential risk to public health or safety, including the risk of a restricted drug being diverted to an illicit market or use.

Validity

J.01.055 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 J.01.060 or J.01.061,
(c) the date of the suspension or revocation of the dealer's licence under section J.01.040 or J.01.041, and
(d) the date of the expiry, suspension or revocation of the import permit that applies to the restricted drug to be exported and that is issued by the competent authority in the country of final destination.

Return of permit

J.01.056 If an export permit expires, the licensed dealer shall, as soon as feasible after its expiry, return the original of the permit to the Minister.

Refusal

J.01.057 (1) The Minister shall refuse to issue an export permit if

(a) the licensed dealer is not authorized by their dealer's licence to export the relevant restricted drug 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 J.01.053(3) or the information or documents that they have provided are not sufficient to complete the review of the 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 with the application;
(e) the licensed dealer has been notified that their application to renew or amend their licence is to 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 restricted drug being diverted to an illicit market or use.

Notice

(2) Before refusing to issue the permit, the Minister shall 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

J.01.058 The holder of an export permit shall provide a copy of the permit to the customs office at the time of exportation.

Declaration

J.01.059 The holder of an export permit shall provide the Minister, within 15 days after the day of export of the restricted drug 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 with respect to the restricted drug;
(b) with respect to the restricted drug,
- (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) in the case of the exportation of a product that contains the restricted drug,
- (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, if any, and
- (iii) the strength per unit of the restricted drug in the product; and
(d) the name of the customs office from which the restricted drug was exported and the date of export.

Suspension

J.01.060 (1) The Minister shall 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 the risk of a restricted drug 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 shall be carried out by the dealer and the date by which the dealer shall do so.

Reinstatement of permit

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

Revocation

J.01.061 (1) Subject to subsection (2), the Minister shall 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 J.01.060(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 with the application;
(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 restricted drug to an illicit market or use; or
(f) the dealer's licence has been revoked.

Exceptions

(2) The Minister shall not revoke an export permit for a ground set out in paragraph (1)(d) or J.01.041(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 preventing a restricted drug 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 this Part; 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 and this Part.

Notice

(3) Before revoking an export permit, the Minister shall 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

J.01.062 If an export permit is revoked, the licensed dealer shall, as soon as feasible after its revocation, return the original of the permit to the Minister.

Identification

Name

J.01.063 A licensed dealer must include its name, as set out in its dealer's licence, on all the means by which it identifies itself in relation to restricted drugs, including product labels, orders, shipping documents, invoices and advertising.

Sale and Provision of Restricted Drugs

Sale to an institution

J.01.064 (1) Despite section C.08.002 and subject to subsections (3) and (4), a licensed dealer may sell a restricted drug to an institution for one of the following purposes if the institution submits to the dealer or the Minister an application to purchase the drug and the Minister issues a prior written authorization for the sale:

(a) for clinical testing in the institution by qualified investigators for the purpose of determining the hazards and efficacy of the drug; or
(b) for laboratory research in the institution by qualified investigators.

Content of application

(2) The application shall contain the following information:

(a) the name and the municipal address of the institution;
(b) the names and qualifications of the qualified investigators;
(c) the name, quantity, form and strength per unit of the restricted drug being requested;
(d) details of the proposed use of the drug; and
(e) the name and municipal address of the licensed dealer from whom the institution proposes to purchase the drug.

Application to licensed dealer

(3) If the institution submits the application to the licensed dealer, the dealer shall provide a copy of it to the Minister.

Authorization by Minister

(4) After reviewing the application received from the institution or the copy of it received from the licensed dealer, the Minister may, subject to any terms and conditions that the Minister has reasonable grounds to believe are necessary, authorize in writing

(a) the sale by the licensed dealer to the institution of the restricted drug applied for in the quantity, form and strength per unit specified by the Minister; and
(b) the possession of the restricted drug by qualified investigators for clinical testing of the drug in the institution for the purpose of determining its hazards and efficacy or to conduct laboratory research with the drug in the institution.

Authorized use only

(5) The institution shall use the restricted drug only in accordance with the written authorization issued by the Minister.

Provision for identification or analysis

J.01.065 (1) Despite anything in this Part, a person may, for the purpose of identification or analysis of a restricted drug, 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 has been exempted under section 56 of the Act with respect to the possession of that restricted drug for that purpose.

Agent or mandatary of practitioner of medecine

(2) An agent or mandatary of a practitioner of medicine who receives the restricted drug shall immediately provide or deliver it to

(a) the practitioner whom they represent; or
(b) the Minister.

Practitioner of medicine

(3) A practitioner of medicine who receives the restricted drug shall immediately provide or deliver it

(a) for the purpose of its identification or analysis, to a person exempted under section 56 of the Act with respect to the possession of that restricted drug for that purpose; or
(b) to the Minister.

Packaging, Labelling and Transportation

Packaging — sale and provision

J.01.066 (1) A licensed dealer who sells or provides a restricted drug shall securely package it in its immediate container, which shall be sealed in such a manner that the container cannot be opened without breaking the seal.

Packaging — transport and export

(2) A licensed dealer who transports or exports a restricted drug shall 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 restricted drug drug and that has a registration number.

Labelling

J.01.067 (1) A package that contains a restricted drug shall be labelled so that its inner and outer labels show

(a) the proper name or, if there is no proper name, the common name of the drug;
(b) the net contents of the package;
(c) the unit strength of the drug and the number of units per package, if the drug is in unit form;
(d) the lot number of the drug;
(e) the words "Restricted Drug"; and
(f) the name and municipal address of the manufacturer or assembler of the drug.

Exception

(2) Subsection (1) does not apply to a test kit that contains a restricted drug and that has a registration number.

Non-application

(3) The labelling requirements set out in section C.01.004 do not apply to a restricted drug.

Transport

J.01.068 A licensed dealer shall, in taking delivery of a restricted drug that they have imported or in making delivery of a restricted drug,

(a) take any measures that are necessary to ensure the security of the drug while it is being transported;
(b) use a method of transportation that permits an accurate record to be kept of all handling of the drug as well as of the signatures of any persons handling it until it is delivered to the consignee;
(c) in the case of an imported drug, ensure that it is transported directly to the site specified in their licence after it is released under the Customs Act; and
(d) in the case of a drug to be exported, transport it directly from the site specified in their licence to the customs office where it is to be exported.

Thefts, Losses and Suspicious Transactions

Protective measures — licences and permits

J.01.069 A licensed dealer shall take any measures that are necessary to ensure the security of any licence or permit in their possession.

Protective measures — restricted drugs

J.01.070 The following persons shall take any measures that are necessary to ensure the security of any restricted drugs in their possession:

(a) a licensed dealer;
(b) an institution;
(c) a qualified investigator who possesses the restricted drug for the purpose of clinical testing or laboratory research in an institution; and
(d) a person exempted under section 56 of the Act with respect to the possession of the restricted drug.

Theft or loss — licences and permits

J.01.071 A licensed dealer who becomes aware of a theft or loss of their licence or permit shall provide a written report to the Minister not later than 72 hours after becoming aware of the occurrence.

Theft or unexplainable loss — restricted drugs

J.01.072 (1) Subject to subsection (2), any person referred to in section J.01.070 who becomes aware of a theft or loss of a restricted drug shall

(a) provide a written report to a member of a police force not later than 24 hours after becoming aware of the occurrence; and
(b) provide a written report to the Minister not later than 72 hours after becoming aware of the occurrence and confirm that the report required under paragraph (a) has been provided.

Explainable loss — licensed dealer

(2) A licensed dealer who becomes aware of a loss of a restricted drug that can be explained on the basis of normally accepted business activities shall provide only a written report to the Minister not later than 10 days after becoming aware of the occurrence.

Suspicious transaction

J.01.073 (1) A licensed dealer shall provide a written report containing the following information to the Minister not later than 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 restricted drug to an illicit market or use:

(a) the 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 involved, including its date and time, its type, the name and quantity of the restricted drug and, in the case of a product or compound, the quantity of every restricted drug that it contains;
(d) in the case of a product that contains the restricted drug, other than a test kit, the drug identification number that is assigned to the product under section C.01.014.2, 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

Partial protection against self-incrimination

J.01.074 A report made under any of sections J.01.071 to J.01.073, 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

Destruction at site

J.01.075 (1) A licensed dealer who destroys a restricted drug at the site specified in their licence shall ensure that the following conditions are met:

(a) the licensed dealer obtains the prior approval of the Minister to carry out the destruction;
(b) the destruction occurs in the presence of two of the following persons, at least one of whom shall be a person referred to in subparagraph (i):
- (i) the senior person in charge, the qualified person in charge or the 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 conducted in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
(d) once the destruction is completed, the person carrying 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 restricted drug was completely destroyed, to which each signatory shall add their name in printed letters.

Destruction elsewhere than at site

(2) A licensed dealer who destroys a restricted drug elsewhere than at the site specified in their licence shall ensure that the following conditions are met:

(a) the licensed dealer obtains the prior approval of the Minister to carry out the destruction;
(b) the licensed dealer takes appropriate measures to ensure the security of the restricted drug while it is being transported in order to prevent the diversion of it 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 conducted in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
(e) once the destruction is completed, the person carrying out the destruction provides the licensed dealer with a dated declaration attesting that the restricted drug was completely destroyed and containing
- (i) the municipal address of the place of destruction,
- (ii) the name and quantity of the restricted drug 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 approval

J.01.076 (1) A licensed dealer shall submit to the Minister an application that contains the following information in order to obtain the Minister's prior approval to destroy a restricted drug:

(a) their name, municipal address and dealer'slicence 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 parargraph J.01.075(1)(b) and information establishing that they meet the conditions of that paragraph;
(f) the name of the restricted drug to be destroyed 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 restricted drug to be destroyed or the product or compound containing it and if applicable, its strength per unit, the number of units per package and the number of packages.

Signature and attestation

(2) The application shall

(a) be signed and dated by the qualified person in charge or the alternate qualified person in charge; and
(b) include an attestation by that person that
- (i) the proposed method of destruction complies with all applicable 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

Approval

J.01.077 On completion of the review of the application, the Minister shall approve the destruction of the restricted drug 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 J.01.075(1)(b) do not meet the conditions of that paragraph;
(b) the Minister has reasonable grounds to believe that the restricted drug 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 with the application;
(d) the restricted drug or a portion of it is required for the purposes of a criminal or administrative investigation or any preliminary inquiry, trial or other proceeding under any Act or its regulations; or
(e) the Minister has reasonable grounds to believe that the approval of the destruction would likely create a risk to public health or safety, including the risk of the restricted drug being diverted to an illicit market or use.

Documents

Licensed Dealers

Method of recording information

J.01.078 A licensed dealer shall record any information that they are required to record under this Part using a method that permits an audit of it to be made at any time.

Information — general

J.01.079 A licensed dealer shall record the following information:

(a) the name and quantity of any restricted drug 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 and quantity of any restricted drug 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 restricted drug that the dealer sells or provides;
- (i) the brand name of the product or the name of the compound containing the restricted drug and the name of the restricted drug,
- (ii) the quantity and, if applicable, the strength per unit of the restricted drug,
- (iii) the name and municipal address of the person to whom it was sold or provided, and
- (iv) the date on which it was sold or provided;
(d) the name and quantity of any restricted drug 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 restricted drug, the number of units per package and the number of packages;
(e) the name and quantity of any restricted drug used 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 and quantity of any restricted drug in stock at the end of each month;
(g) the name and the quantity of any restricted drug 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) in the case of an importation, the name and quantity of any restricted drug imported, 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) in the case of an exportation, the name and quantity of any restricted drug exported, 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.

Destruction

J.01.080 A licensed dealer shall record the following information concerning any restricted drug that they destroy at the site specified in their licence:

(a) the municipal address of the place of destruction;
(b) the name and quantity of the restricted drug and, if applicable, the brand name and quantity of the product containing the drug or the name and quantity of the compound containing the drug;
(c) the method of destruction; and
(d) the date of destruction.

Annual report

J.01.081 (1) Subject to subsections (2) and (3), a licensed dealer shall provide to the Minister, within three months after the end of each calendar year, an annual report that contains

(a) the name and total quantity of each restricted drug that they receive, produce, use to produce a product or compound, sell, provide, import, export or destroy during the calendar year;
(b) the quantity of each restricted drug in physical inventory taken at the site specified in their licence at the end of the calendar year; and
(c) the name and quantity of any restricted drug that has been lost in the course of conducting activities during the calendar year.

Non-renewal or revocation within first three months

(2) A licensed dealer whose licence expires without being renewed or is revoked within the first three months of a calendar year shall 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 months 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

Institutions

Method of recording information

J.01.082 An institution shall record any information that it is required to record under this Part using a method that permits an audit of the information to be made at any time.

Information

J.01.083 An institution shall record the following information:

(a) the name and quantity of any restricted drug that the institution orders, the name of the person who placed the order on the institution's behalf and the date of the order;
(b) the name and quantity of any restricted drug that the institution receives as well as the name and municipal address of the licensed dealer who sold or provided it and the date on which it was received;
(c) details of the use of restricted drugs in the institution;
(d) the names and qualifications of every person who makes use of a restricted drug in the institution; and
(e) all clinical data with respect to the use of every restricted drug received by the institution.

Drug Received for Identification and Analysis

Method of recording information

J.01.084 A person who records information in accordance with section J.01.085 shall do so using a method that permits an audit of the information to be made at any time.

Information

J.01.085 A person who receives a restricted drug in accordance with section J.01.065 shall record the following information:

(a) the name and quantity of the restricted drug, as well as the name and municipal address of the person who provided it to them and the date on which it was received;
(b) details regarding the identification or analysis of the restricted drug; and
(c) the names of the persons who handled the restricted drug during the process of identifying or analyzing it.

Record Keeping

Retention period

J.01.086 A licensed dealer, former licensed dealer, an institution and a person referred to in section J.01.085 shall keep any document containing the information that they are required to record under this Part, including every declaration and a copy of every report, for a two-year period beginning on 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 any time.

Location

J.01.087 The documents shall be kept

(a) in the case of a licensed dealer, at the site specified in their licence;
(b) in the case of an institution, at the institution;
(c) in the case of a person referred to in section J.01.085, at a location in Canada; and
(d) in the case of a former licensed dealer, at a location in Canada.

Quality of documents

J.01.088 The documents must be complete and readily retrievable and the information in them must be legible and indelible.

Notification of Application for Order of Restoration

Written notification

J.01.089 (1) For the purpose of subsection 24(1) of the Act, notification of an application for an order of restoration shall be given in writing to the Attorney General by registered mail and shall be mailed at least 15 days before the date on which the application is to be made to a justice.

Content of notification

(2) The notification shall 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 restricted drug 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 restricted drug or other thing referred to in paragraph (c).

18 The schedule to Part J of the Regulations is amended by replacing the references after the heading "SCHEDULE" with the following:

(Sections J.01.001, J.01.002 and J.01.004.)

Coming into Force

19 These Regulations come into force on the 180th day after the day on which they are published in the Canada Gazette, Part II.