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

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to subsection 55(1)footnote a of the Controlled Drugs and Substances Actfootnote 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drug offence, export permit, import permit, package and transhipment in subsection 1(1) of the Regulations are repealed.

(3) The definition personne qualifiée responsable in subsection 1(1) of the French version of the Regulations is repealed.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

(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 :

(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

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

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

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

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

Signature and attestation

(2) The application must

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

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

Effect of cancellation

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

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:

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

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

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:

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:

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

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,

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:

Documents

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

Signature and attestation

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

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

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

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:

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

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

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

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:

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

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

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

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:

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:

Information and documents

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

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

Refusal

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

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

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

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:

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:

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

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

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

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

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:

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:

Signature and attestation

(2) The application must

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:

Validity

25.2 An import permit is valid until the earliest of

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

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:

Suspension

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

Notice

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

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

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:

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:

Signature and attestation

(2) The application must

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

Validity

28.2 An export permit is valid until the earliest of

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

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:

Suspension

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

Notice

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

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

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:

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

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:

Conditions

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

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

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,

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

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:

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 :

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:

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:

Signature and attestation

(2) The application must

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

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:

Verbal order

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

Destruction

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

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

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

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:

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

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

(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:

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

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:

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:

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

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

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

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

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:

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

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

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

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

Circumstances

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

Recipients

(3) The notice must be sent to

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

Measures before sending

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

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

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

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

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:

Documents

(2) The application must be accompanied by

Signature and attestation

(3) The application must

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

Refusal

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

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.