Canada Gazette, Part I, Volume 152, Number 25: Regulations Amending the Benzodiazepines and Other Targeted Substances Regulations (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 Benzodiazepines and Other Targeted Substances Regulations (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 Benzodiazepines and Other Targeted Substances Regulations (Licences and Permits)

Amendments

1 (1) The portion of subsection 1(1) of the English version of the Benzodiazepines and Other Targeted Substances Regulations ^{footnote 1} before the first definition is replaced by the following:

1 The following definitions apply in these Regulations.

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drug offence, export permit, import permit, package and transhipment in subsection 1(1) of the Regulations are repealed.

(3) The definition personne qualifiée responsable in subsection 1(1) of the French version of the Regulations is repealed.

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

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

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

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

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)

targeted substance means a controlled substance set out in Schedule 1. (substance ciblée)

test kit means a kit

• (a) that contains a targeted substance and a reagent system or buffering agent;
• (b) that is used during the course of a chemical or analytical procedure to test for the presence or quantity of a targeted substance for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose; and
• (c) the contents of which are not intended or likely to be consumed by, or administered to, a person or an animal. (nécessaire d'essai)
  

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

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

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

hôpital L'établissement :

• a) qui peut, au titre d'une licence, d'une autorisation ou d'une désignation délivrée par une province sous le régime de ses lois, fournir des soins de santé ou des traitements aux personnes ou aux animaux;
• b) qui fournit des services de santé et qui soit appartient au gouvernement du Canada ou au gouvernement d'une province, soit est exploité par lui. (hospital)

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

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

designated criminal offence 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 targeted substance, means to alter or denature it to such an extent that its consumption is rendered impossible or improbable. (destruction)

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

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

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

(9) Subsection 1(2) of the Regulations is repealed.

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

Application

Member of police force

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

Possession

Authorized persons

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

• (a) requires the targeted substance for their business or profession and is
  • (i) a licensed dealer,
  • (ii) a pharmacist, or
  • (iii) a practitioner who is registered and entitled to practise in the province in which they possess the targeted substance;
• (b) is a practitioner who is registered and entitled to practise in a province other than the province in which they possess the targeted substance and their possession is for emergency medical purposes only;
• (c) is a hospital employee or a practitioner in a hospital;
• (d) has obtained the targeted substance for their own use or the use of another individual for whom, or an animal for which, they are responsible
  • (i) from a practitioner, or
  • (ii) in accordance with a prescription that was not issued or obtained in contravention of these Regulations;
• (e) is employed as an inspector, a member of the Royal Canadian Mounted Police, a police constable, a peace officer or a member of the technical or scientific staff of the Government of Canada, the government of a province or a university in Canada and their possession is in connection with that employment;
• (f) is exempt under section 56 of the Act with respect to the possession of that targeted substance and their possession is for a purpose set out in the exemption;
• (g) has imported the targeted substance in accordance with section 68 for their own use or the use of another individual for whom, or an animal for which, they are responsible;
• (h) a person who, in accordance with a permit for transit or transhipment, is responsible for the targeted substance while it is in transit or in transhipment in Canada; or
• (i) the Minister.
  

Agent or mandatary

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

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

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

• (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)(e); and
• (b) their possession of the targeted substance is for the purpose of assisting that person in the administration or enforcement of an Act or regulation.
  

Export by individual

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

Test Kits

Authorized activities

4 A person may sell, possess or otherwise deal in a test kit if

• (a) a registration number has been issued for the test kit under section 6 or subsection 10(2) and has not been cancelled under subsection 9(1);
• (b) the test kit is labelled with
  • (i) the registration number, and
  • (ii) in the case of a test kit that is not subject to the labelling requirements of the Medical Devices Regulations,
    • (A) the name and address of the manufacturer or assembler or, in the case where the test kit is manufactured or assembled in accordance with a custom order, the name and address of the person for whom the test kit was custom manufactured or assembled, and
    • (B) its brand name; 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

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

• (a) the brand name of the test kit;
• (b) a detailed description of the design and construction of the test kit;
• (c) a detailed description of the targeted substance and other substances, if any, contained in the test kit, including
  • (i) the specified name of the targeted substance and the name of any other substance,
  • (ii) if the substance is a salt, the name of the salt, and
  • (iii) the quantity of the substance;
• (d) a description of the proposed use of the test kit; and
• (e) the directions for use of the test kit.

Signature and attestation

(2) The application must

• (a) be signed and dated by the person authorized by the applicant for that purpose; and
• (b) include an attestation by that person that all of the information submitted in support of the application is correct and complete to the best of their knowledge.

Additional information or document

(3) The applicant must 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

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

Refusal

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

• (a) the test kit poses a risk to public health or safety, including the risk of the targeted substance in the test kit being diverted to an illicit market or use, because
  • (i) the total amount of the targeted substance in the test kit is too high, or
  • (ii) the adulterating or denaturing agent in the test kit is not likely to prevent or deter consumption of the targeted substance in the test kit by a human or animal or the administration of that substance to a human or animal; or
• (b) the test kit is likely to be used for a purpose other than one referred to in section 6 .
  

Notice

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

Labelling — non-application

8 The requirement in subparagraph C.01.004(1)(b)(iv) of the Food and Drug Regulations that a symbol be displayed on the label of a targeted substance does not apply to a test kit if a registration number has been issued for it under section 6 or subsection 10(2) and the number is displayed on the label.

Cancellation

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

• (a) the Minister receives a notice from the holder of the registration number stating that they have ceased to conduct all activities with respect to the test kit;
• (b) the test kit is a medical device and is no longer approved for sale in Canada under the Medical Devices Regulations;
• (c) a reason referred to in paragraph 7(1)(a) exists; or
• (d) if the Minister has reasonable grounds to believe that the test kit is being used for a purpose other than a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose and that it poses a risk to public health or safety, including the risk of the targeted substance in the test kit being diverted to an illicit market or use.
  

Effect of cancellation

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

• (a) must not be displayed on the label of any test kit manufactured or assembled after the cancellation; and
• (b) in the case of a cancellation under paragraph (1)(a), must remain on the label of any existing test kit until all of the test kits with that registration number are disposed of.

Application for new number

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

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

New number

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

Notice to the Minister

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

• (a) ceased to conduct all activities with respect to the test kit;
• (b) transferred the manufacturing or assembly of the test kit to another person;
• (c) increased the quantity of targeted substance in the test kit;
• (d) changed the brand name of the test kit;
• (e) altered in any manner the adulterating or denaturing agent in the test kit or changed the quantity of either agent in it; or
• (f) substituted a new adulterating or denaturing agent.
  

Licensed Dealers

Authorized Activities

General

12 (1) A licensed dealer may produce, assemble, sell, provide, transport, send, deliver, import or export a targeted substance if they comply with

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

Qualified person in charge present

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

Permit — import and export

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

Possession for export

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

Licences

Preliminary Requirements

Eligible persons

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

• (a) an individual who ordinarily resides in Canada;
• (b) a corporation that has its head office in Canada or operates a branch office in Canada; or
• (c) the holder of a position that includes responsibility for targeted substances on behalf of the Government of Canada or of a government of a province, a police force, a hospital or a university in Canada.
  

Senior person in charge

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

Qualified person in charge

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

Alternate qualified person in charge

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

Qualifications

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

• (a) they work at the site specified in the dealer's licence;
• (b) they
  • (i) are 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) hold a diploma, certificate or credential awarded by a post-secondary educational institution in Canada in a field or occupation that is relevant to their duties, such as pharmacy, medicine, dentistry, veterinary medicine, pharmacology, chemistry, biology, pharmacy technician, laboratory technician, pharmaceutical regulatory affairs or supply chain management or security, or
  • (iii) hold a diploma, certificate or credential that is awarded by a foreign educational institution in a field or occupation referred to in subparagraph (ii) and hold
    • (A) an equivalency assessment as defined in subsection 73(1) of the Immigration and Refugee Protection Regulations, or
    • (B) an equivalency assessment issued by an organization or institution that is responsible for issuing equivalency assessments and is recognized by a province;
• (c) they have sufficient knowledge of and experience with the use and handling of the targeted substances specified in the licence to properly carry out their duties; and
• (d) they have sufficient knowledge of the provisions of the Act and these Regulations that are applicable to the activities specified in the licence to properly carry out their duties.
  

Exception

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

• (a) no other individual working at the site meets those requirements;
• (b) those requirements are not necessary for the activities specified in the licence; and
• (c) the individual has sufficient knowledge — acquired from a combination of education, training or work experience — to properly carry out their duties.
  

Ineligibility

16 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 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 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

17 (1) A person who intends to conduct an activity referred to in section 12 must obtain a dealer's licence for each site at which they 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 described in paragraph 13(c), the applicant's name and the title of the position;
• (b) the municipal address, telephone number and, if applicable, the 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 targeted substances in respect of which each of the activities is to be conducted;
• (f) if the licence is requested to manufacture or assemble a product or compound that contains a targeted substance, other than a test kit, a list that includes, for each product or compound,
  • (i) the brand name of the product or the name of the compound,
  • (ii) the drug identification number that is assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any,
  • (iii) the specified name and the strength per unit of the targeted substance 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 licence number of the other licensed dealer, and
  • (vi) if the applicant's name appears on the label of the product or compound, a copy of the inner label, as defined in section A.01.010 of the Food and Drug Regulations;
• (g) if the licence is requested to produce a targeted substance other than a product or compound that contains a targeted substance,
  • (i) its specified 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 specified name of the targeted substance for which the activity is to be conducted and the purpose of the activity;
• (i) a detailed description of the security measures in place at the site, determined in accordance with the Security Directive; and
• (j) a detailed description of the method for recording information that the applicant proposes to use for the purpose of section 39.
  

Documents

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

• (a) if the applicant is a corporation, a copy of
  • (i) the certificate of incorporation or other constituting instrument, and
  • (ii) any document filed with the province in which its site is located that states its corporate name and any other name registered with the province under which the applicant intends to conduct the activities specified in its dealer's licence or by which it intends to identify itself;
• (b) individual declarations signed and dated by each of the 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 16;
• (c) a document issued by a Canadian police force in relation to each person referred to in paragraph (b), indicating whether, during the 10 years before the day on which the application is submitted, the person was convicted as specified in subparagraph 16(a)(i) or received a sentence as specified in subparagraph 16(a)(ii);
• (d) if any of the persons referred to in paragraph (b) has ordinarily resided in a country other than Canada during the 10 years before the day on which the application is submitted, a document issued by a police force of that country indicating whether in that period that person was convicted as specified in subparagraph 16(b)(i) or received a sentence as specified in subparagraph 16(b)(ii);
• (e) a declaration, signed and dated by the 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 15(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 15(3)(b)(i), either
  • (i) a copy of the person's diploma, certificate or credential referred to in subparagraph 15(3)(b)(ii) or (iii) 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 15(4)(c), together with supporting evidence, such as a copy of a course transcript or an attestation by the person who provided the training.

Signature and attestation

(3) An application for a dealer's licence must

• (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 of the information and documents submitted in support of the application are correct and complete to the best of their knowledge, and
  • (ii) they have the authority to bind the applicant.

Additional information and documents

(4) The applicant must provide the Minister with any information or document that the Minister determines is necessary to complete the Minister's review of the application, by the date specified in the Minister's written request to that effect.

Issuance

17.1 Subject to section 17.4, on completion of the review of the licence application, the Minister must issue a dealer's licence, with or without terms and conditions, that contains

• (a) the licence number;
• (b) the name of the licensed dealer, their corporate name or the title of the position they hold;
• (c) the activities that are authorized and the specified names of the targeted substances in respect of which each activity may be conducted;
• (d) the municipal address of the site at which the 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 must 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 targeted substance being diverted to an illicit market or use; and
• (i) if the licensed dealer produces a targeted substance, the quantity that they may produce and the authorized production period.

Validity

17.2 A dealer's licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section 23 or 24.

Return of licence

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

Refusal

17.4 (1) The Minister must refuse to issue a dealer's licence if

• (a) the applicant is not eligible under section 13;
• (b) during the 10 years before the day on which the licence application is submitted, the applicant has contravened
  • (i) a provision of the Act 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 16(a)(i) or (b)(i) or received a sentence as specified in subparagraph 16(a)(ii) or (b)(ii);
• (d) an activity for which the licence is requested would contravene an international obligation;
• (e) the applicant does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the licence is requested;
• (f) the method referred to in paragraph 17(1)(j) does not permit the recording of information as required by section 39;
• (g) the applicant has not complied with the requirements of subsection 17(4) or the information or documents that they have provided are not sufficient to complete the review of the 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 targeted substance to an illicit market or use or has been involved in an activity that contravenes an international obligation; or
• (j) the Minister has reasonable grounds to believe that the issuance of the licence would likely create a risk to public health or safety, including the risk of a targeted substance being diverted to an illicit market or use.
  

Exceptions

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

• (a) the applicant does not have a history of non-compliance with the Act 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 these Regulations.

Notice

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

Renewal

Application

18 (1) To apply to renew a dealer's licence, a licensed dealer must submit to the Minister an application that contains the information and documents referred to in subsections 17(1) and (2).

Signature and attestation

(2) An application must

• (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 must provide the Ministerwith 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

18.1 (1) Subject to section 18.4, on completion of the review of the renewal application, the Minister must issue a renewed dealer's licence that contains the information specified in section 17.1.

Terms and conditions

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

• (a) ensure that an international obligation is respected;
• (b) ensure conformity with the requirements associated with the security level specified in the licence or the new level required as a result of the licence renewal; or
• (c) reduce a potential risk to public health or safety, including the risk of a targeted substance being diverted to an illicit market or use.
  

Validity

18.2 A renewed dealer's licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section 23 or 24.

Return of previous licence

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

Refusal

18.4 (1) The Minister must refuse to renew a dealer's licence if

• (a) the licensed dealer is no longer eligible under section 13;
• (b) during the 10 years before the day on which the renewal application is submitted, the licensed dealer has contravened
  • (i) a provision of the Act or these Regulations, or
  • (ii) a term or condition of a licence or permit issued to the dealer under these Regulations;
• (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 16(a)(i) or (b)(i) or received a sentence as specified in subparagraph 16(a)(ii) or (b)(ii);
• (d) an activity for which the renewal is requested would contravene an international obligation;
• (e) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the renewal is requested;
• (f) the method referred to in paragraph 17(1)(j) does not permit the recording of information as required by section 39;
• (g) the licensed dealer has not complied with the requirements of subsection 18(3) or the information or documents that they have provided are not sufficient to complete the review of the 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 targeted substance to an illicit market or use or has been involved in an activity that contravened an international obligation; or
• (j) the Minister has reasonable grounds to believe that the renewal of the licence would likely create a risk to public health or safety, including the risk of a targeted substance being diverted to an illicit market or use.
  

Exceptions

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

• (a) the licensed dealer does not have a history of non-compliance with the Act or these Regulations; and
• (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and these Regulations.

Notice

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

Amendment

Application

19 (1) Before making a change affecting any information referred to in section 17.1 that is contained in their dealer's licence, a licensed dealer must submit to the Minister an application to amend the licence that contains a description of the proposed amendment, as well as the information and documents referred to in section 17 that are relevant to the proposed amendment.

Signature and attestation

(2) The application must

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

19.1 (1) Subject to section 19.4, on completion of the review of the application, the Minister must amend the dealer's licence.

Terms and conditions

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

• (a) ensure that an international obligation is respected;
• (b) ensure conformity with the requirements associated with the security level specified in the licence or the new level required as a result of the licence amendment; or
• (c) reduce a potential risk to public health or safety, including the risk of a targeted substance being diverted to an illicit market or use.
  

Validity

19.2 An amended dealer's licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section 23 or 24.

Return of previous licence

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

Refusal

19.4 (1) The Minister must refuse to amend a dealer's licence if

• (a) an activity for which the amendment is requested would contravene an international obligation;
• (b) the licensed dealer does not have in place at the site the security measures set out in the Security Directive in respect of an activity for which the amendment is requested;
• (c) the method referred to in paragraph 17(1)(j) does not permit the recording of information as required by section 39;
• (d) the licensed dealer has not complied with the requirements of subsection 19(3) or the information or documents that they have provided are not sufficient to complete the review of the 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 targeted substance being diverted to an illicit market or use.
  

Exceptions

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

• (a) the licensed dealer does not have a history of non-compliance with the Act or these Regulations; and
• (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and these Regulations.

Notice

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

Changes Requiring Prior Approval

Application

20 (1) A licensed dealer must obtain the Minister's approval before making any of the following changes by submitting a written application to the Minister:

• (a) a change affecting the security measures in place at the site specified in the dealer's licence;
• (b) the replacement of the senior person in charge;
• (c) the replacement of the qualified person in charge; or
• (d) the replacement or addition of an alternate qualified person in charge.

Information and documents

(2) The licensed dealer must provide the Minister with the following with respect to any change referred to in 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 17(1)(c), and
  • (ii) the declaration specified in paragraph 17(2)(b) and the documents specified in paragraphs 17(2)(c) and (d); and
• (c) in the case of the qualified person in charge or an alternate qualified person in charge,
  • (i) the information specified in paragraph 17(1)(d), and
  • (ii) the declarations specified in paragraphs 17(2)(b) and (e) and the documents specified in paragraphs 17(2)(c), (d) and (f).

Additional information and documents

(3) The licensed dealer must 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.

Approval

20.1 (1) Subject to section 20.2, on completion of the review of the application, the Minister must approve the change.

Terms and conditions

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

• (a) ensure that an international obligation is respected;
• (b) ensure conformity with the requirements associated with the security level specified in the licence; or
• (c) reduce a potential risk to public health or safety, including the risk of a targeted substance being diverted to an illicit market or use.
  

Refusal

20.2 (1) The Minister must refuse to approve the change if

• (a) during the 10 years before the day on which the application is submitted, the proposed senior person in charge, qualified person in charge or alternate qualified person in charge was convicted as specified in subparagraph 16(a)(i) or (b)(i) or received a sentence as specified in subparagraph 16(a)(ii) or (b)(ii);
• (b) the licensed dealer has not complied with the requirements of subsection 20(3) or the information or documents that they have provided are not sufficient to complete the review of the application;
• (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 targeted substance being diverted to an illicit market or use.
  

Exceptions

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

Notice

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

Changes Requiring Notice

Prior notice

21 (1) A licensed dealer must notify the Minister in writing before

• (a) manufacturing or assembling a product or compound that is not set out in the most recent version of the list referred to in paragraph 17(1)(f) that 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 must contain the information referred to in paragraph 17(1)(f) that is necessary to update the list and must be accompanied by the revised version of the list.

Notice as soon as feasible

21.1 A licensed dealer must notify the Minister in writing as soon as feasible of

• (a) a change at the site at which a targeted substance 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

21.2 A licensed dealer must 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

21.3 (1) A licensed dealer must 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 17(1)(f) that the licensed dealer has submitted to the Minister.

Information and list

(2) A notice submitted under paragraph (1)(b) must specify which information referred to in paragraph 17(1)(f) is being changed and must be accompanied by the revised version of the list.

Notice of cessation of activities

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

Content of notice

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

• (a) the expected date of the cessation of activities at the site;
• (b) a description of the manner in which any remaining targeted substances on the site as of that date will be 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 must submit to the Minister a detailed update of the information referred to in subsection (2) if it differs from what was set out in the notice. The update must be signed and dated by the senior person in charge.

Changes to Terms and Conditions

Adding or modifying term or condition

22 (1) The Minister may, at any time other than at the issuance, renewal or amendment of a dealer's licence, add a term or condition to it or modify one if the Minister has reasonable grounds to believe that it is necessary to do so to

• (a) ensure that an international obligation is respected;
• (b) ensure conformity with the requirements associated with the security level specified in the licence; or
• (c) reduce a potential risk to public health or safety, including the risk of a targeted substance being diverted to an illicit market or use.
  

Notice

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

Urgent circumstances

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

Urgent circumstances — notice

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

Deletion of term or condition

22.1 (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

22.2 The licensed dealer must, 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

23 (1) The Minister must suspend a dealer's licence without prior notice if the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including preventing a targeted substance from being diverted to an illicit market or use.

Notice

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

• (a) sets out the reasons for the suspension;
• (b) gives the dealer an opportunity to be heard; and
• (c) if applicable, specifies the corrective measures that must be carried out by the dealer and the date by which the dealer must do so.
  

Reinstatement of licence

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

Revocation

24 (1) Subject to subsection (2), the Minister must revoke a dealer's licence if

• (a) the licensed dealer is no longer eligible under section 13;
• (b) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the licence or the actual or potential unauthorized use of the licence;
• (c) the licensed dealer ceases to conduct activities at their site before the expiry of their licence;
• (d) the licensed dealer does not take the corrective measures specified in an undertaking or notice;
• (e) the licensed dealer has contravened
  • (i) a provision of the Act or these Regulation, or
  • (ii) a term or condition of a licence or permit issued to the dealer under these Regulations;
• (f) during the 10 years before the day on which the licence is revoked, the senior person in charge, the qualified person in charge or the alternate qualified person in charge was convicted as specified in subparagraph 16(a)(i) or (b)(i) or received a sentence as specified in subparagraph 16(a)(ii) or (b)(ii);
• (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 targeted substance to an illicit market or use.
  

Exceptions

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

• (a) the licensed dealer does not have a history of non-compliance with the Act or these Regulations; and
• (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and these Regulations.

Notice

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

Return of licence

24.1 The licensed dealer must, as soon as feasible after the effective date of the revocation, return the original of the licence to the Minister.

Import Permits

Application

25 (1) A licensed dealer must submit to the Minister, before each importation of a targeted substance, an application for an import permit that contains the following information:

• (a) their name, municipal address and dealer's licence number;
• (b) with respect to the targeted substance to be imported,
  • (i) its specified name, as set out in the dealer's licence,
  • (ii) if it is a salt, the name of the salt,
  • (iii) its quantity, and
  • (iv) in the case of a raw material, its purity and its anhydrous content;
• (c) in the case of the importation of a product that contains the targeted substance,
  • (i) the brand name of the product,
  • (ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any, and
  • (iii) the strength per unit of the targeted substance in the product;
• (d) the name and municipal address, in the country of export, of the exporter from whom the targeted substance is being obtained;
• (e) the name of the customs office where the importation is anticipated; and
• (f) each proposed mode of transportation to be used, and any proposed country of transit or transhipment.
  

Signature and attestation

(2) The application must

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

(3) The licensed dealer must 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

25.1 Subject to section 25.4, on completion of the review of the import permit application, the Minister must issue to the licensed dealer an import permit that contains:

• (a) the permit number;
• (b) the information set out in subsection 25(1);
• (c) the effective date of the permit;
• (d) the expiry date of the permit, which must 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 targeted substance being diverted to an illicit market or use.
    

Validity

25.2 An import permit is valid until the earliest of

• (a) the expiry date set out in the permit,
• (b) the date of the suspension or revocation of the permit under section 26 or 27,
• (c) the date of the suspension or revocation of the dealer's licence under section 23 or 24, and
• (d) the date of the expiry, suspension or revocation of the export permit that applies to the targeted substance to be imported and that is issued by the competent authority in the country of export.
  

Return of permit

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

Refusal

25.4 (1) The Minister must refuse to issue an import permit if

• (a) the licensed dealer is not authorized by their dealer's licence to import the relevant targeted substance or their 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 25(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 targeted substance being diverted to an illicit market or use.
  

Notice

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

Providing copy of permit

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

Declaration

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

• (a) their name and the numbers of their dealer's licence and the import permit with respect to the targeted substance;
• (b) with respect to the targeted substance,
  • (i) its specified 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 targeted substance,
  • (i) the brand name of the product,
  • (ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any, and
  • (iii) the strength per unit of the targeted substance in the product; and
• (d) the name of the customs office from which the targeted substance was released and the date of the release.
  

Suspension

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

• (a) the dealer's licence is suspended;
• (b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health or safety, including the risk of a targeted substance being diverted to an illicit market or use; or
• (c) the importation would contravene the laws of the country of export or any country of transit or transhipment.

Notice

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

• (a) sets out the reasons for the suspension;
• (b) gives the dealer an opportunity to be heard; and
• (c) if applicable, specifies the corrective measures that must be carried out by the dealer and the date by which the dealer must do so.
  

Reinstatement of permit

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

Revocation

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

• (a) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the permit or the actual or potential unauthorized use of the permit;
• (b) the licensed dealer does not carry out the corrective measures specified by the Minister under paragraph 26(2)(c) by the specified date;
• (c) the licensed dealer has contravened a term or condition of the permit;
• (d) the Minister has reasonable grounds to believe that the licensed dealer submitted false or misleading information or false or falsified documents in or 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 targeted substance to an illicit market or use; or
• (f) the dealer's licence has been revoked.
  

Exceptions

(2) The Minister must not revoke an import permit for a ground set out in paragraph (1)(d) or 24(1)(e) or (g) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including preventing a targeted substance from being diverted to an illicit market or use:

• (a) the licensed dealer does not have a history of non-compliance with the Act or these Regulations; and
• (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and these Regulations.

Notice

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

Return of permit

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

Export Permits

Application

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

• (a) their name, municipal address and dealer's licence number;
• (b) with respect to the targeted substance to be exported,
  • (i) its specified name, as set out in the dealer's licence,
  • (ii) if it is a salt, the name of the salt,
  • (iii) its quantity, and
  • (iv) in the case of a raw material, its purity and its anhydrous content;
• (c) in the case of the exportation of a product that contains the targeted substance,
  • (i) the brand name of the product,
  • (ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any, and
  • (iii) the strength per unit of the targeted substance in the product;
• (d) the name and municipal address of the importer in the country of final destination;
• (e) the name of the customs office where the exportation is anticipated;
• (f) each proposed mode of transportation to be used and any proposed country of transit or transhipment; and
• (g) a copy of the import permit issued by the competent authority in the country of final destination that sets out the name of the importer and the municipal address of their site in that country.

Signature and attestation

(2) The application must

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

(3) The licensed dealer must 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

28.1 Subject to section 28.4, on completion of the review of the export permit application, the Minister must issue to the licensed dealer an export permit that contains

• (a) the permit number;
• (b) the information set out in paragraphs 28(1)(a) to (f);
• (c) the effective date of the permit;
• (d) the expiry date of the permit, which must 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 the competent authority in the country of final destination; and
• (e) any terms and conditions that the Minister has reasonable grounds to believe are necessary to
  • (i) ensure that an international obligation is respected, or
  • (ii) reduce a potential risk to public health or safety, including the risk of a targeted substance being diverted to an illicit market or use.
    

Validity

28.2 An export permit is valid until the earliest of

• (a) the expiry date set out in the permit,
• (b) the date of the suspension or revocation of the permit under section 29 or 30,
• (c) the date of the suspension or revocation of the dealer's licence under section 23 or 24, and
• (d) the date of the expiry, suspension or revocation of the import permit that applies to the targeted substance to be exported and that is issued by the competent authority in the country of final destination.
  

Return of permit

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

Refusal

28.4 (1) The Minister must refuse to issue an export permit if

• (a) the licensed dealer is not authorized by their dealer's licence to export the relevant targeted substance or their dealer's licence will expire before the date of export;
• (b) the Minister has reasonable grounds to believe that the exportation would contravene an international obligation;
• (c) the licensed dealer has not complied with the requirements of subsection 28(3) or the information or documents that they have provided are not sufficient to complete the review of the 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 targeted substance being diverted to an illicit market or use.
  

Notice

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

Providing copy of permit

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

Declaration

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

• (a) their name and the numbers of their dealer's licence and the export permit with respect to the targeted substance;
• (b) with respect to the targeted substance,
  • (i) its specified name, as set out in the dealer's licence,
  • (ii) if it is a salt, the name of the salt, and
  • (iii) its quantity;
• (c) in the case of the exportation of a product that contains the targeted substance,
  • (i) the brand name of the product,
  • (ii) the drug identification number that has been assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any, and
  • (iii) the strength per unit of the targeted substance in the product; and
• (d) the name of the customs office from which the targeted substance was exported and the date of export.
  

Suspension

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

• (a) the dealer's licence is suspended;
• (b) the Minister has reasonable grounds to believe that the suspension is necessary to protect public health or safety, including the risk of a targeted substance being diverted to an illicit market or use; or
• (c) the exportation would contravene the laws of the country of final destination, or any country of transit or transhipment.

Notice

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

• (a) sets out the reasons for the suspension;
• (b) gives the dealer an opportunity to be heard; and
• (c) if applicable, specifies the corrective measures that must be carried out by the dealer and the date by which the dealer must do so.
  

Reinstatement of permit

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

Revocation

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

• (a) the licensed dealer requests the Minister to do so or informs the Minister of the loss or theft of the permit or the actual or potential unauthorized use of the permit;
• (b) the licensed dealer does not carry out the corrective measures specified by the Minister under paragraph 29(2)(c) by the specified date;
• (c) the licensed dealer has contravened a term or condition of the permit;
• (d) the Minister has reasonable grounds to believe that the licensed dealer submitted false or misleading information or false or falsified documents in or 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 targeted substance to an illicit market or use; or
• (f) the dealer's licence has been revoked.
  

Exceptions

(2) The Minister must not revoke an export permit for a ground set out in paragraph (1)(d) or 24(1)(e) or (g) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including preventing a targeted substance from being diverted to an illicit market or use:

• (a) the licensed dealer does not have a history of non-compliance with the Act or these Regulations; and
• (b) the licensed dealer has carried out, or signed an undertaking to carry out, the necessary corrective measures to ensure compliance with the Act and these Regulations.

Notice

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

Return of permit

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

Identification

Name

31 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 targeted substances, including product labels, orders, shipping documents, invoices and advertising.

Sale and Provision of Targeted Substances

Specified persons

32 (1) Subject to subsections (2) and (3), a licensed dealer may sell or provide a targeted substance to

• (a) another licensed dealer;
• (b) a pharmacist;
• (c) a practitioner;
• (d) a hospital;
• (e) a person to whom an exemption relating to the substance has been granted under section 56 of the Act; or
• (f) the Minister.
  

Midwife, nurse practitioner or podiatrist

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

Exception — pharmacist or practitioner named in notice

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

Order required

33 (1) A licensed dealer may sell or provide a targeted substance in accordance with section 32 if the licensed dealer has received from one of the following persons a written or verbal order indicating the specified name and the quantity of the substance and, in the case of a written order, the conditions specified in subsection (2) are met:

• (a) in the case of a licensed dealer, a person who is authorized to place an order for the substance on their behalf;
• (b) in the case of a hospital, the pharmacist in charge of the hospital's pharmacy or a practitioner authorized by the person in charge of the hospital to sign the order; or
• (c) in any other case, the person to whom the substance is to be sold or provided.
  

Conditions

(2) The following conditions apply to a written order:

• (a) it must be signed and dated by one of the persons referred to in subsection (1); and
• (b) the licensed dealer must verify the signature if it is unknown to them.
  

Anticipated multiple sales

33.1 (1) A licensed dealer may sell or provide a targeted substance more than once in respect of one order if the order indicates

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

Multiple sales — insufficient stock

(2) A licensed dealer may sell or provide a targeted substance more than once in respect of one order if at the time of receipt of the order the licensed dealer temporarily does not have in stock the quantity of the substance ordered, in which case the licensed dealer may sell or provide against the order the quantity of the substance that the licensed dealer has available and deliver the balance later.

Packaging and Transportation

Packaging — sale and provision

34 (1) A licensed dealer who sells or provides a targeted substance must securely package it in its immediate container, which must be sealed in such a manner that the container cannot be opened without breaking the seal.

Packaging — transport and export

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

Exception

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

Transport

34.1 A licensed dealer must, in taking delivery of a targeted substance that they have imported or in making delivery of a targeted substance,

• (a) take any measures that are necessary to ensure the security of the targeted substance while it is being transported;
• (b) in the case of an imported targeted substance, ensure that it is transported directly to the site specified in their licence after it is released under the Customs Act; and
  • (i) in the case of a targeted substance that is to be exported, transport it directly from the site specified in their licence to the customs office where it is to be exported.

Thefts, Losses and Suspicious Transactions

Protective measures

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

Theft or loss — licences and permits

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

Theft or unexplainable loss — targeted substances

35.2 A licensed dealer who becomes aware of a theft of a targeted substance or of a loss of a targeted substance that cannot be explained on the basis of normally accepted business activities must

• (a) provide a written report to a member of a police force 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 — targeted substances

35.3 A licensed dealer who becomes aware of a loss of a targeted substance that can be explained on the basis of normally accepted business activities must provide a written report to the Minister not later than 10 days after becoming aware of the occurrence.

Suspicious transaction

35.4 (1) A licensed dealer must 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 targeted substance 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 targeted substance and, in the case of a product or compound, the quantity of every targeted substance that it contains;
• (d) in the case of a product that contains the targeted substance, other than a test kit, the drug identification number that is assigned to the product under section C.01.014.2 of the Food and Drug Regulations, if any; and
• (e) a detailed description of the reasons for those suspicions.
  

Good faith

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

Non-disclosure

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

Partial protection against self-incrimination

35.5 A report made under any of sections 35.2 to 35.4, 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

36 (1) A licensed dealer who destroys a targeted substance at the site specified in their licence must ensure that the following conditions are met :

• (a) the licensed dealer obtains the prior approval of the Minister to carry out the destruction;
• (b) the destruction is carried out in the presence of two of the following persons, at least one of whom must be a person referred to in subparagraph (i):
  • (i) the senior person in charge, the qualified person in charge or 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 carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
• (d) once the destruction is completed, the person who carried out the destruction and each of the two persons referred to in paragraph (b) who were present at the destruction sign and date a joint declaration attesting that the targeted substance was completely destroyed, to which each signatory must add their name in printed letters.

Destruction elsewhere than at site

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

• (a) the licensed dealer obtains the prior approval of the Minister to carry out the destruction;
• (b) the licensed dealer takes appropriate measures to ensure the security of the targeted substance while it is being transported in order to prevent its diversion to an illicit market or use;
• (c) the destruction is carried out by a person working for a business that specializes in the destruction of dangerous goods and in the presence of another person working for that business;
• (d) the destruction is carried out in accordance with a method that complies with all federal, provincial and municipal environmental protection legislation applicable to the place of destruction; and
• (e) once the destruction is completed, the person who carried out the destruction provides the licensed dealer with a dated declaration attesting that the targeted substance was completely destroyed and containing
  • (i) the municipal address of the place of destruction,
  • (ii) the specified name and quantity of the targeted substance and, if applicable, the brand name and quantity of the product containing it or the name and quantity of the compound containing it,
  • (iii) the method of destruction,
  • (iv) the date of destruction, and
  • (v) the names in printed letters and signatures of that person and the other person who was present at the destruction.
    

Application for approval

37 (1) A licensed dealer must submit to the Minister an application that contains the following information in order to obtain the Minister's prior approval to destroy a targeted substance:

• (a) their name, municipal address and dealer's licence number;
• (b) the proposed date of destruction;
• (c) the municipal address of the place of destruction;
• (d) a brief description of the method of destruction;
• (e) if the destruction is to be carried out at the site specified in the dealer's licence, the names of the persons proposed for the purpose of paragraph 36(1)(b) and information establishing that they meet the conditions of that paragraph;
• (f) the specified name of the targeted substance to be destroyed and, if applicable, the brand name of the product containing it or the name of the compound containing it; and
• (g) the form and quantity of the targeted substance to be destroyed or the product or compound containing it and, if applicable, its strength per unit, the number of units per package and the number of packages.
  

Signature and attestation

(2) The application must

• (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

(3) The licensed dealer must 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.

Approval

38 On completion of the review of the application, the Minister must approve the destruction of the targeted substance unless

• (a) in the case of a destruction that is to be carried out at the site specified in the dealer's licence, the persons proposed for the purpose of paragraph 36(1)(b) do not meet the conditions of that paragraph;
• (b) the Minister has reasonable grounds to believe that the targeted substance would not be destroyed;
• (c) the Minister has reasonable grounds to believe that the licensed dealer has submitted false or misleading information or false or falsified documents in or with the application;
• (d) the targeted substance or a portion of it is required for the purposes of a criminal or administrative investigation or any preliminary inquiry, trial or other proceeding under any Act or 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 targeted substance being diverted to an illicit market or use.
  

Documents

Method of recording information

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

Information — general

40 A licensed dealer must record the following information:

• (a) the specified name and the quantity of any targeted substance that the dealer orders, the name of the person who placed the order on the dealer's behalf and the date of the order;
• (b) the specified name and the quantity of any targeted substance that the dealer receives, the name and municipal address of the person who sold or provided it and the date on which it was received;
• (c) in the case of a targeted substance that the dealer sells or provides,
  • (i) the brand name of the product or the name of the compound containing the targeted substance and the specified name of the targeted substance,
  • (ii) the quantity and, if applicable, the strength per unit of the targeted substance,
  • (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 specified name and the quantity of any targeted substance that the dealer produces and the date on which it was placed in stock and, if applicable, the strength per unit of the targeted substance, the number of units per package and the number of packages;
• (e) the specified name and the quantity of any targeted substance 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 specified name and the quantity of any targeted substance in stock at the end of each month;
• (g) the specified name and the quantity of any targeted substance that the dealer delivers, transports or sends, the name and municipal address of the consignee and the date on which it was delivered, transported or sent;
• (h) in the case of an importation, the specified name and the quantity of any targeted substance 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 specified name and the quantity of any targeted substance 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 order

41 A licensed dealer who receives a verbal order for a targeted substance must immediately record the following information:

• (a) the name of the person who placed the order;
• (b) the date on which the order was received; and
• (c) the name of the person recording the order.

Destruction

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

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

Annual report

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

• (a) the specified name and the total quantity of each targeted substance that they receive, produce, assemble, use to produce a product or compound, sell, provide, import, export or destroy during the calendar year;
• (b) the quantity of each targeted substance in physical inventory taken at the site specified in their licence at the end of the calendar year; and
• (c) the specified name and the quantity of any targeted substance 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 must provide to the Minister

• (a) within three months after the end of the preceding calendar year, the annual report in respect of that year; and
• (b) within three months after the expiry or revocation, a report in respect of the 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 must provide to the Minister, within three months after the expiry or revocation, a report in respect of the portion of the calendar year during which the licence was valid that contains the information referred to in subsection (1) for that period, including the quantity in physical inventory on the date of expiry or revocation.

3 The heading "PART 2" before section 48 of the Regulations is repealed.

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

Application

48 Sections 49 to 56 do not apply to a pharmacist when practising in a hospital.

Authorization

49 A pharmacist may, in accordance with sections 50 to 57, compound a targeted substance pursuant to a prescription.

5 Paragraph 55(1)(d) of the French version of the Regulations is replaced by the following:

• d) la personne qui bénéficie d'une exemption relative à la substance ciblée et accordée en vertu de l'article 56 de la Loi, si la commande est faite par écrit et accompagnée d'une copie de l'exemption.

6 The heading "PART 3" before section 58 of the Regulations is repealed.

7 Section 59 of the Regulations is replaced by the following:

Emergency supply

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

Emergency use

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

• (a) the practitioner of medicine has, by telephone or other means, directed them to administer the targeted substance; or
• (b) they follow written directives provided by the practitioner with respect to the administration of the targeted substance.

8 (1) Paragraph 60(1)(d) of the English version of the Regulations is replaced by the following:

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

(2) Subsection 60(2) of the English version of the Regulations is replaced by the following:

Records — agent or mandatary

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

• (a) the name, strength per unit and quantity of each targeted substance administered and the date on which it was administered;
• (b) the name of the individual to whom the targeted substance was administered; and
• (c) the name of the agent or mandatary of the practitioner who administered the targeted substance.

9 Section 61 of the Regulations is replaced by the following:

Obligations — agent or mandatary

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

• (a) take reasonable steps to protect any targeted substance in their possession from loss and theft; and
• (b) inform the practitioner without delay of any loss or theft of a targeted substance.

Obligations — practitioner of medicine

(2) A practitioner of medicine who is informed by their agent or mandatary of the loss or theft of a targeted substance must inform the Minister in accordance with subsection 72(2).

10 The heading "PART 4" before section 63 of the Regulations is repealed.

11 Subsection 63(1) of the Regulations is replaced by the following:

Authorization

63 (1) A hospital may, in accordance with subsection (2) and sections 64 to 67, sell, provide, administer, send, deliver or transport a targeted substance.

12 The portion of paragraph 65(1)(c) of the French version of the Regulations before subparagraph (i) is replaced by the following:

• c) la personne qui bénéficie d'une exemption relative à la substance ciblée et accordée en vertu de l'article 56 de la Loi, si :

13 The heading "PART 5" before section 68 of the Regulations is repealed.

14 (1) Subparagraphs 68(1)(b)(i) and (ii) of the French version of the Regulations are replaced by the following:

• (i) soit pour son utilisation personnelle,
• (ii) soit pour l'utilisation personnelle d'une personne physique dont il est responsable et qui l'accompagne,

(2) Subparagraph 68(1)(b)(iii) of the Regulations is replaced by the following:

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

15 (1) Subparagraphs 69(b)(i) and (ii) of the French version of the Regulations are replaced by the following:

• (i) soit pour son utilisation personnelle,
• (ii) soit pour l'utilisation personnelle d'une personne physique dont elle est responsable et qui l'accompagne,

(2) Subparagraph 69(b)(iii) of the Regulations is replaced by the following:

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

16 The headings before section 70 and sections 70 to 82 of the Regulations are replaced by the following:

Verification of Identity

Order

70 Every person who fills an order or prescription for a targeted substance must verify the identity of the person who gave the order or issued the prescription if

• (a) the signature on the order or prescription is unknown to the person; or
• (b) the order or prescription is verbal and the person placing it is not known to the person.
  

Storage

Place

71 Subject to section 59, every person who is authorized under these Regulations to deal in a targeted substance and who stores the targeted substance must do so in the place used for the purpose of conducting their business or professional practice and in the area in that place where only authorized employees have access, except where the targeted substance is for for their own use or the use of another individual for whom, or an animal for which, they are responsible.

Security

Protective measures

72 (1) The following persons must take any measures that are necessary to ensure the security of any targeted substance in their possession:

• (a) a pharmacist;
• (b) a practitioner;
• (c) the person in charge of a hospital;
• (d) a person to whom an exemption has been granted under section 56 of the Act; and
• (e) a person who, in accordance with a permit for transit or transhipment, is responsible for the targeted substance while it is in transit or in transhipment in Canada.
  

Theft or loss

(2) A person referred to in subsection (1) who becomes aware of a theft or loss of a targeted substance must provide a written report to the Minister not later than 10 days after becoming aware of the occurrence.

Destruction

Restriction

73 (1) Subject to subsection (2) and section 36, a person must not destroy a targeted substance unless they have received it in accordance with these Regulations for their own use or the use of another individual for whom, or an animal for which, they are responsible.

Conditions

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

• (a) subject to subsection (3), the destruction is witnessed by a pharmacist or practitioner;
• (b) the targeted substance is destroyed using a method that complies with all federal, provincial and municipal environmental legislation applicable to the place of destruction;
• (c) they record the following information:
  • (i) the municipal address of the place of destruction,
  • (ii) the specified name of the targeted substance to be destroyed and, if applicable, the brand name of the product containing it or the name of the compound containing it,
  • (iii) the form and quantity of the targeted substance to be destroyed or the product or compound containing it and, if applicable, its strength per unit, the number of units per package and the number of packages,
  • (iv) the method of destruction, and
  • (v) the date of the destruction; and
• (d) immediately following the destruction, the person who carried out the destruction and the pharmacist or practitioner who witnessed it sign and date a joint declaration attesting that the targeted substance was completely destroyed, to which each signatory must add their name in printed letters.
  

Exception — open ampule

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

Documents

Alteration prohibited

74 A person must not make any mark on or alter or deface in any manner any licence, permit or registration number issued under these Regulations.

Retention period

75 A person must keep any document containing all of the information that they are required to record under these Regulations, including every declaration and a copy of every report, for a 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 at any time.

Location

76 The documents must be kept

• (a) in the case of a licensed dealer, at the site specified in their licence; and
• (b) in the case of a former licensed dealer or any other person, at a location in Canada.

Quality of documents

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

Advertising

Restrictions

78 A person must not

• (a) advertise a targeted substance to the general public; or
• (b) issue or publish an advertisement for a targeted substance unless the advertisement
  • (i) is published in literature distributed to, or in a trade publication for, licensed dealers, pharmacists, practitioners or hospitals, and
  • (ii) displays the following symbol in a clear and conspicuous colour and size in the upper left quarter of its first page:
  • 

Minister

Notice to cease sell targeted substances

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

• (a) pharmacists practising in the notified pharmacies and all licensed dealers must not sell or provide any targeted substance to the pharmacist or the practitioner named in the notice;
• (b) pharmacists practising in the notified pharmacies must not fill a order or prescription for any targeted substance provided by the practitioner named in the notice; or
• (c) both paragraphs (a) and (b) apply with respect to the practitioner named in the notice.
  

Circumstances

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

• (a) made a request to the Minister in accordance with subsection 57(1) or section 62 to send the notice;
• (b) has contravened a rule of conduct established by the provincial professional licensing authority in the province in which the pharmacist or practitioner is practising and the authority has requested the Minister in writing to send the notice; or
• (c) been convicted of a designated substance offence or of an offence under these Regulations.

Recipients

(3) The notice must be sent to

• (a) all licensed dealers;
• (b) all pharmacies within the province in which the pharmacist or practitioner named in the notice is registered and entitled to practise and is practising;
• (c) the provincial professional licensing authority of the province in which the pharmacist or practitioner named in the notice is registered and entitled to practise;
• (d) any pharmacies in an adjacent province in which a prescription or order from the pharmacist or practitioner named in the notice may be filled; and
• (e) any provincial professional licensing authority in another province that has has requested the Minister in writing to send the notice.
  

Other circumstances

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

• (a) has contravened a provision of the Act or these Regulations;
• (b) has, on more than one occasion, self-administered a targeted substance under a self-directed prescription or order or, in the absence of a prescription or order, contrary to accepted pharmaceutical, medical, dental or veterinary practice;
• (c) has, on more than one occasion, prescribed, administered or provided a targeted substance to a person who is a spouse, common-law partner, parent or child of the pharmacist or practitioner, including a child adopted in fact, contrary to accepted professional practice; or
• (d) is unable to account for a quantity of targeted substance for which the pharmacist or practitioner was responsible under these Regulations.

Measures before sending

(5) The measures to be taken for the purposes of subsection (4) are that the Minister has

• (a) consulted with the provincial professional licensing authority of the province in which the pharmacist or practitioner to whom the notice relates is registered and entitled to practise;
• (b) given that pharmacist or practitioner an opportunity to be heard; and
• (c) considered
  • (i) the compliance history of the pharmacist or practitioner in respect of the Act and its regulations, and
  • (ii) whether the actions of the pharmacist or practitioner pose a significant risk to public health or safety, including the risk of the targeted substance being diverted to an illicit market or use.

Retraction

80 The Minister must provide the persons and authorities who were sent a notice under subsection 79(1) with a notice of retraction of that notice if

• (a) in the circumstance described in paragraph 79(2)(a), the requirements set out in subparagraphs (b)(i) and (ii) have been met and one year has elapsed since the notice was sent by the Minister; or
• (b) in the circumstance described in any of paragraphs 79(2)(b) and (c) and (4)(a) to (d), the pharmacist or the practitioner named in the notice has
  • (i) requested in writing that a retraction of the notice be sent, and
  • (ii) provided a letter from the provincial professional licensing authority of the province in which the pharmacist or practitioner is registered and entitled to practise in which the authority consents to the retraction of the notice.

Provision of information to licensing authority

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

• (a) in the province in which the person is or was registered and entitled to practise if
  • (i) the authority submits a written request that sets out the name and address of the person, a description of the information being requested and a statement that the information is required for the purpose of assisting a lawful investigation by the authority, or
  • (ii) the Minister has reasonable grounds to believe that the person has
    • (A) contravened a rule of conduct established by the authority,
    • (B) been convicted of a designated substance offence, or
    • (C) contravened these Regulations; or
• (b) in a province in which the person is not registered and entitled to practise, if the authority submits to the Minister
  • (i) a written request that sets out the person's name and address and a description of the information being requested, and
  • (ii) a document that shows that
    • (A) the person has applied to that authority to practise in that province, or
    • (B) the authority has reasonable grounds to believe that the person is practising in that province without being authorized to do so.
      

Definition of nurse

(2) For the purpose of subsection (1), nurse does not include a nurse practitioner.

Notification of Application for Order of Restoration

Written notification

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

Information

(2) The notification must specify

• (a) the name of the justice to whom the application is to be made;
• (b) the time and place at which the application is to be heard;
• (c) details concerning the targeted substance or other thing in respect of which the application is to be made; and
• (d) the evidence on which the applicant intends to rely to establish that the applicant is entitled to possession of the targeted substance or other thing referred to in paragraph (c).

Permit in Transit or Transhipment

Application

83 (1) If a targeted substance is being shipped from a country of export to a foreign country by a route that requires it to be in transit through Canada or to be transhipped in Canada, the exporter in the country of export or their agent or mandatary in Canada must obtain a permit for the transit or transhipment of the targeted substance by submitting to the Minister an application that contains the following information:

• (a) the name, municipal address and telephone number of the exporter in the country of export;
• (b) the name, municipal address and telephone number of the person who will be responsible for the targeted substance while it is in Canada;
• (c) with respect to the targeted substance,
  • (i) its specified name and, if applicable, its brand name,
  • (ii) if it is a salt, the name of the salt,
  • (iii) its quantity, and
  • (iv) in the case of a raw material, its purity and its anhydrous content;
• (d) the expected date of transit or transhipment in Canada;
• (e) the name of the customs office where the importation or exportation is anticipated;
• (f) each proposed mode of transportation in Canada; and
• (g) in the case of a transhipment, the municipal address of every place in Canada at which the targeted substance will be stored during the transhipment and the expected duration of each storage.

Documents

(2) The application must be accompanied by

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

Signature and attestation

(3) The application must

• (a) be signed and dated by a person who is authorized for that purpose by the exporter, including an agent or mandatary in Canada of that exporter; and
• (b) include an attestation by that person that all the information submitted in support of the application is correct and complete to the best of their knowledge.

Additional information and documents

(4) The applicant must 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

84 (1) Subject to subsection (2), on completion of the review of the permit application the Minister must issue a permit for transit or transhipment that contains

• (a) the name, municipal address and telephone number of the exporter in the country of export;
• (b) the name, municipal address and telephone number of the person who is responsible for the targeted substance while it is in Canada;
• (c) the specified name, quantity, purity and strength per unit of the targeted substance;
• (d) the countries of export and final destination and the numbers and expiry dates of the export and import permits issued by a competent authority in each of those countries;
• (e) the expected date of the transit or transhipment in Canada;
• (f) the name of the customs office where the importation or exportation is anticipated;
• (g) each proposed mode of transportation in Canada;
• (h) in the case of a transhipment, the municipal address of every place in Canada at which the targeted substance may be stored during the transhipment and the duration of each storage; and
• (i) the dates of issuance and expiry of the permit.
  

Refusal

(2) The Minister must refuse to issue a permit for transit or transhipment if the Minister has reasonable grounds to believe that

• (a) the issuance of the permit
  • (i) would not be in conformity with an international obligation,
  • (ii) would be in contravention of the Act, the regulations, another Act of Parliament, or a law of the country of export, of the country of final destination or of a country of transit or transhipment, or
  • (iii) would likely create a risk to public health or safety, including the risk of the targeted substance being diverted to an illicit market or use; or
• (b) the import permit issued by a competent authority in the country of final destination has expired or has been suspended or revoked.
  

17 Schedule 1 to the Regulations is amended by replacing the references after the heading "SCHEDULE 1" with the following:

(Subsection 1(1) and section 3 )

Coming into Force

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