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

June 23, 2018

Statutory authority
Controlled Drugs and Substances Act

Sponsoring department
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

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

PROPOSED REGULATORY TEXT

PROPOSED REGULATORY TEXT

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

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

Ottawa, June 7, 2018

Jurica Čapkun
Assistant Clerk of the Privy Council

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

Amendments

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

DIVISION 1

Definitions

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

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

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

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

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

compound includes a preparation. (composé)

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

designated criminal offence means

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

hospital means a facility

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

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

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

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

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

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

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

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

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

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

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

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

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

test kit means a kit

Application

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

Member of police force
G.01.003 A member of a police force or a person acting under their direction and control who, in respect of the conduct of the member or person, is exempt from the application of subsection 4(2) or section 5, 6 or 7 of the Act by virtue of the Controlled Drugs and Substances Act (Police Enforcement) Regulations is, in respect of that conduct, exempt from the application of this Part.

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

Possession

Authorized persons
G.01.005 (1) A person is authorized to possess a controlled drug set out in any of items 1 to 3, 8 to 10, 12 to 14, 16 or 17 of Part I of the schedule to this Part if the person has obtained the controlled drug in accordance with these Regulations, in the course of activities conducted in connection with the administration or enforcement of an Act or regulation, or from a person who is exempt under section 56 of the Act from the application of subsection 5(1) of the Act with respect to that controlled drug, and the person

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

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

Test Kits

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

Application for registration number
G.01.007 (1) The manufacturer of a test kit may obtain a registration number for it by submitting to the Minister an application containing

Signature and attestation
(2) The application shall

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

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

Cancellation of registration number
G.01.009 The Minister shall cancel the registration number for a test kit if

DIVISION 2

Licensed Dealers
Authorized Activities

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

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

Permit — import and export
(3) A licensed dealer shall obtain a permit to import or export a controlled drug.

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

Licences
Preliminary Requirements

Eligible persons
G.02.002 The following persons may apply for a dealer’s licence:

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

Qualified person in charge
G.02.004 (1) An applicant for a dealer’s licence shall designate only one individual as the qualified person in charge, who is responsible for supervising the activities with respect to controlled drugs that are specified in the licence application and for ensuring that those activities comply with this Part. The applicant may designate themself if the applicant is an individual.

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

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

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
G.02.005 A person is not eligible to be a senior person in charge, a qualified person in charge or an alternate qualified person in charge if, during the 10 years before the day on which the dealer’s licence application is submitted,

Application, Issuance, Validity and Refusal

Application
G.02.006 (1) A person who intends to conduct an activity referred to in section G.02.001 shall obtain a dealer’s licence for each site at which they plan to conduct activities by submitting an application to the Minister that contains the following information:

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

Signature and attestation
(3) An application for a dealer’s licence shall

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

Issuance
G.02.007 Subject to section G.02.010, on completion of the review of the licence application, the Minister shall issue a dealer’s licence, with or without terms and conditions, that contains

Validity
G.02.008 A dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section G.02.032 or G.02.033.

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

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

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

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

Renewal

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

Signature and attestation
(2) An application shall

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

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

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

Validity
G.02.013 A renewed dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section G.02.032 or G.02.033.

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

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

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

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

Amendment

Application
G.02.016 (1) Before making a change affecting any information referred to in section G.02.007 that is contained in their dealer’s licence, a licensed dealer shall submit to the Minister an application to amend the licence that contains a description of the proposed amendment, as well as the information and documents referred to in section G.02.006 that are relevant to the proposed amendment.

Signature and attestation

(2) The application shall

Additional information and documents

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

Amendment

G.02.017 (1) Subject to section G.02.020, on completion of the review of the amendment application, the Minister shall amend the dealer’s licence.

Terms and conditions

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

Validity

G.02.018 An amended dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section G.02.032 or G.02.033.

Return of previous licence

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

Refusal

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

Exceptions

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

Notice

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

Changes Requiring Prior Approval

Application

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

Information and documents

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

Additional information and documents

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

Approval

G.02.022 (1) Subject to section G.02.023, on completion of the review of the application, the Minister shall approve the change.

Terms and conditions

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

Refusal

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

Exception

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

Notice

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

Changes Requiring Notice

Prior notice

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

Information and list

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

Notice as soon as feasible

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

Notice — next business day

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

Notice — 10 days

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

Information and list

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

Notice of cessation of activities

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

Content of notice

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

Update

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

Changes to Terms and Conditions

Adding or modifying term or condition

G.02.029 (1) The Minister may, at a time other than the issuance, renewal or amendment of a dealer’s licence, add a term or condition to it or modify one if the Minister has reasonable grounds to believe that it is necessary to do so to

Notice

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

Urgent circumstances

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

Urgent circumstances — notice

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

Deletion of a term or condition

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

Notice

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

Return of previous licence

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

Suspension and Revocation

Suspension

G.02.032 (1) The Minister shall suspend a dealer’s licence without prior notice if the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including preventing a controlled drug from being diverted to an illicit market or use.

Notice

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

Reinstatement of licence

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

Revocation

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

Exceptions

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

Notice

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

Return of licence

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

Import Permits

Application

G.02.035 (1) A licensed dealer shall submit to the Minister, before each importation of a controlled drug, an application for an import permit that contains the following information:

Signature and attestation

(2) The application shall

Additional information and documents

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

Issuance

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

Validity

G.02.037 An import permit is valid until the earliest of

Return of permit

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

Refusal

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

Notice

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

Providing copy of permit

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

Declaration

G.02.041 The holder of an import permit shall provide the Minister, within 15 days after the day of release of the controlled drug specified in the permit in accordance with the Customs Act, with a declaration that contains the following information:

Suspension

G.02.042 (1) The Minister shall 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 shall reinstate the import permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary.

Revocation

G.02.043 (1) Subject to subsection (2), the Minister shall revoke an import permit if

Exceptions

(2) The Minister shall not revoke an import permit for a ground set out in paragraph (1)(d) or G.02.033(1)(e) or (g) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including preventing a controlled drug from being diverted to an illicit market or use:

Notice

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

Return of permit

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

Export Permits

Application

G.02.045 (1) A licensed dealer shall submit to the Minister, before each exportation of a controlled drug, an application for an export permit that contains the following information and document:

Signature and attestation

(2) The application shall

Additional information and documents

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

Issuance

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

Validity

G.02.047 An export permit is valid until the earliest of

Return of permit

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

Refusal

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

Notice

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

Providing copy of permit

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

Declaration

G.02.051 The holder of an export permit shall provide the Minister, within 15 days after the day of export of the controlled drug specified in the permit, with a declaration that contains the following information:

Suspension

G.02.052 (1) The Minister shall 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 shall reinstate the export permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary.

Revocation

G.02.053 (1) Subject to subsection (2), the Minister shall revoke an export permit if

Exceptions

(2) The Minister shall not revoke an export permit for a ground set out in paragraph (1)(d) or G.02.033(1)(e) or (g) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including preventing a controlled drug from being diverted to an illicit market or use:

Notice

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

Return of permit

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

Identification

Name

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

Sale and Provision of Controlled Drugs

Sale to licensed dealer

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

Sale to pharmacist

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

Exception — pharmacist named in a notice

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

Retraction

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

Sale to a practitioner

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

Midwife, nurse practitioner or podiatrist

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

Exception — practitioner named in a notice

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

Provision to hospital employee

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

Sale to exempted person

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

Written order

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

Verbal order

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

Receipt

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

No further sale without receipt

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

Anticipated multiple sales

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

Multiple sales — insufficient stock

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

Packaging and Transportation

Packaging — sale and provision

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

Packaging — transport and export

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

Exception

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

Transport

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

Exception

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

Thefts, Losses and Suspicious Transactions

Protective measures

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

Theft or loss — licences and permits

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

Theft or unexplainable loss — controlled drugs

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

Explainable loss — controlled drugs

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

Suspicious transaction

G.02.070 (1) A licensed dealer shall provide a written report containing the following information to the Minister not later than 72 hours after becoming aware of a transaction occurring in the course of their activities that they have reasonable grounds to suspect may be related to the diversion of a controlled drug to an illicit market or use:

Good faith

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

Non-disclosure

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

Partial protection against self-incrimination

G.02.071 A report made under any of sections G.02.067 to G.02.070, or any evidence derived from it, is not to be used or received to incriminate the licensed dealer in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

Destruction

Destruction at site

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

Destruction elsewhere than at site

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

Application for approval

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

Signature and attestation

(2) The application shall

Additional information and documents

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

Approval

G.02.074 On completion of the review of the application, the Minister shall approve the destruction of the controlled drug unless

Documents

Method of recording information

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

Information — general

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

Verbal orders

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

Destruction

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

Annual report

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

Non-renewal or revocation within first three months

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

Non-renewal or revocation after third month

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

Retention of documents

G.02.080 (1) A licensed dealer or former licensed dealer shall keep any document containing the information that they are required to record under this Part, including every declaration and a copy of every report, for a two-year period beginning on after the day on which the last record is recorded in the document and in a manner that permits an audit of the document to be made any time.

Location

(2) The documents shall be kept

Quality of documents

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

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

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

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

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

G.03.007 If, in accordance with a written order or prescription, a pharmacist dispenses a controlled drug listed in Part I of the schedule to this Part, other than a preparation, the pharmacist shall immediately enter in a book, register or similar record maintained for such purposes

G.03.008 A pharmacist shall, before dispensing a controlled drug in accordance with a verbal order or prescription, make a written record of it that sets out

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

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

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

G.03.017 The Minister shall provide in writing any factual information about a pharmacist that has been obtained under the Act or this Part to the provincial professional licensing authority that is responsible for the registration and authorization of the person to practise their profession

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

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

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

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

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

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

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

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

designated drug means any of the following controlled drugs:

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

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

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

10 Paragraphs G.04.002(1)(a) and (b) of the Regulations are replaced by the following:

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

G.04.004 The Minister shall provide in writing any factual information about a practitioner that has been obtained under the Act or this Part to the provincial professional licensing authority responsible for the registration and authorization of the person to practise their profession

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

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

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

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

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

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

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

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

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

DIVISION 6

General

Labelling — drug dispensed in accordance with prescription

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

Labelling — test kit

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

Provision for identification or analysis

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

Agent or mandatary of practitioner of medicine

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

Practitioner of medicine

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

Advertising

G.06.004 No person shall

Symbol - Detailed information can be found in the surrounding text.

Records — exempted person

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

Communication by Minister

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

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

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

Nurses

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

Non-application

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

Notification of application for order of restoration

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

Content of notification

(2) The notification shall specify

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

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

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

Definitions

Definitions

J.01.001 The following definitions apply in this Part.

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

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

compound includes a preparation. (composé)

designated criminal offence means

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

hospital means a facility

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

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

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

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

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

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

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

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

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

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

restricted drug means

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

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

test kit means a kit

General

Temporary accelerated scheduling

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

Deletion from Part III of schedule

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

Deletion — Schedule V to Act

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

Non-application — police force

J.01.003 A member of a police force or a person acting under their direction and control who, in respect of the conduct of the member or person, is exempt from the application of subsection 4(2) or section 5, 6 or 7 of the Act by virtue of the Controlled Drugs and Substances Act (Police Enforcement) Regulations is, in respect of that conduct, exempt from the application of this Part.

Possession

Authorized persons

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

Agent or mandatary

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

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

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

Test Kits

Authorized activities

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

Application for registration number

J.01.006 (1) The manufacturer of a test kit may obtain a registration number for it by submitting to the Minister an application containing

Signature and attestation

(2) The application shall

Additional information or document

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

Issuance of registration number

J.01.007 On completion of the review of the application for a registration number, the Minister shall issue a registration number for the test kit, preceded by the letters “TK”, if the Minister is satisfied that the test kit will only be used for a medical, laboratory, industrial, educational, law administration or enforcement, or research purpose and that it contains

Cancellation of registration number

J.01.008 The Minister shall cancel the registration number for a test kit if

Licensed Dealers

Authorized Activities

General

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

Qualified person in charge present

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

Permit — import and export

(3) A licensed dealer shall obtain a permit to import or export a restricted drug.

Possession for export

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

Licences
Preliminary Requirements

Eligible persons

J.01.010 The following persons may apply for a dealer’s licence:

Senior person in charge

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

Qualified person in charge

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

Alternate qualified person in charge

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

Qualifications

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

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

J.01.013 A person is not eligible to be a senior person in charge, a qualified person in charge or an alternate qualified person in charge if, during the 10 years before the day on which the dealer’s licence application is submitted,

Application, Issuance, Validity and Refusal

Application

J.01.014 (1) A person who intends to conduct an activity referred to in section J.01.009 shall obtain a dealer’s licence for each site at which they plan to conduct activities by submitting an application to the Minister that contains the following information:

Documents

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

Signature and attestation

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

Additional information and documents

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

Issuance

J.01.015 Subject to section J.01.018, on completion of the review of the licence application, the Minister shall issue a dealer’s licence, with or without terms and conditions, that contains

Validity

J.01.016 A dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section J.01.040 or J.01.041.

Return of licence

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

Refusal

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

Exceptions

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

Notice

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

Renewal

Application

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

Signature and attestation

(2) An application shall

Additional information and documents

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

Renewal

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

Terms and conditions

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

Validity

J.01.021 A renewed dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section J.01.040 or J.01.041.

Return of previous licence

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

Refusal

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

Exceptions

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

Notice

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

Amendment

Application

J.01.024 (1) Before making a change affecting any information referred to in section J.01.015 that is contained in their dealer’s licence, a licensed dealer shall submit to the Minister an application to amend the licence that contains a description of the proposed amendment, as well as the information and documents referred to in section J.01.014 that are relevant to the proposed amendment.

Signature and attestation

(2) The application shall

Additional information and documents

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

Amendment

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

Terms and conditions

(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

J.01.026 An amended dealer’s licence is valid until the expiry date set out in the licence or, if it is earlier, the date of the suspension or revocation of the licence under section J.01.040 or J.01.041.

Return of previous licence

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

Refusal

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

Exception

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

Notice

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

Changes Requiring Prior Approval

Application

J.01.029 (1) A licensed dealer shall obtain the Minister’s approval before making any of the following changes by submitting a written application to the Minister:

Information and documents

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

Additional information and documents

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

Approval

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

Terms and conditions

(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

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

Exception

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

Notice

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

Changes Requiring Notice

Prior notice

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

Information and list

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

Notice as soon as feasible

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

Notice — next business day

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

Notice — 10 days

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

Information and list

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

Notice of cessation of activities

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

Content of notice

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

Update

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

Changes to Terms and Conditions

Adding or modifying term or condition

J.01.037 (1) The Minister may, at any time other than at the issuance, renewal or amendment of a dealer’s licence, add a term or condition to it or modify one if the Minister has reasonable grounds to believe that it is necessary to do so to

Notice

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

Urgent circumstances

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

Urgent circumstances — notice

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

Deletion of a term or condition

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

Notice

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

Return of previous licence

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

Suspension and Revocation

Suspension

J.01.040 (1) The Minister shall suspend a dealer’s licence without prior notice if the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including preventing a restricted drug from being diverted to an illicit market or use.

Notice

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

Reinstatement of licence

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

Revocation

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

Exceptions

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

Notice

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

Return of licence

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

Import Permits

Application

J.01.043 (1) A licensed dealer shall submit to the Minister, before each importation of a restricted drug, an application for an import permit that contains the following information:

Signature and attestation

(2) The application shall

Additional information and documents

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

Issuance

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

Validity

J.01.045 An import permit is valid until the earliest of

Return of permit

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

Refusal

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

Notice

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

Providing copy of permit

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

Declaration

J.01.049 The holder of an import permit shall provide the Minister, within 15 days after the day of release of the restricted drug specified in the permit in accordance with the Customs Act, with a declaration that contains the following information:

Suspension

J.01.050 (1) The Minister shall 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 shall reinstate the import permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary.

Revocation

J.01.051 (1) Subject to subsection (2), the Minister shall revoke an import permit if

Exceptions

(2) The Minister shall not revoke an import permit for a ground set out in paragraph (1)(e) or J.01.041(1)(e) or (g) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including preventing a restricted drug from being diverted to an illicit market or use:

Notice

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

Return of permit

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

Export Permits

Application

J.01.053 (1) A licensed dealer shall submit to the Minister, before each exportation of a restricted drug, an application for an export permit that contains the following information and document:

Signature and attestation

(2) The application shall

Additional information and documents

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

Issuance

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

Validity

J.01.055 An export permit is valid until the earliest of

Return of permit

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

Refusal

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

Notice

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

Providing copy of permit

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

Declaration

J.01.059 The holder of an export permit shall provide the Minister, within 15 days after the day of export of the restricted drug specified in the permit, with a declaration that contains the following information:

Suspension

J.01.060 (1) The Minister shall 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 shall reinstate the export permit if the Minister has reasonable grounds to believe that the suspension is no longer necessary.

Revocation

J.01.061 (1) Subject to subsection (2), the Minister shall revoke an export permit if

Exceptions

(2) The Minister shall not revoke an export permit for a ground set out in paragraph (1)(d) or J.01.041(1)(e) or (g) if the licensed dealer meets the following conditions, unless the Minister has reasonable grounds to believe that it is necessary to do so to protect public health or safety, including preventing a restricted drug from being diverted to an illicit market or use:

Notice

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

Return of permit

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

Identification

Name

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

Sale and Provision of Restricted Drugs

Sale to an institution

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

Content of application

(2) The application shall contain the following information:

Application to licensed dealer

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

Authorization by Minister

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

Authorized use only

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

Provision for identification or analysis

J.01.065 (1) Despite anything in this Part, a person may, for the purpose of identification or analysis of a restricted drug, provide or deliver it to

Agent or mandatary of practitioner of medecine

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

Practitioner of medicine

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

Packaging, Labelling and Transportation

Packaging — sale and provision

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

Packaging — transport and export

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

Exception

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

Labelling

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

Exception

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

Non-application

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

Transport

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

Thefts, Losses and Suspicious Transactions

Protective measures — licences and permits

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

Protective measures — restricted drugs

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

Theft or loss — licences and permits

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

Theft or unexplainable loss — restricted drugs

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

Explainable loss — licensed dealer

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

Suspicious transaction

J.01.073 (1) A licensed dealer shall provide a written report containing the following information to the Minister not later than 72 hours after becoming aware of a transaction occurring in the course of their activities that they have reasonable grounds to suspect may be related to the diversion of a restricted drug to an illicit market or use:

Good faith

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

Non-disclosure

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

Partial protection against self-incrimination

J.01.074 A report made under any of sections J.01.071 to J.01.073, or any evidence derived from it, is not to be used or received to incriminate the licensed dealer in any criminal proceeding against them other than a prosecution under section 132, 136 or 137 of the Criminal Code.

Destruction

Destruction at site

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

Destruction elsewhere than at site

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

Application for approval

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

Signature and attestation

(2) The application shall

Additional information and documents

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

Approval

J.01.077 On completion of the review of the application, the Minister shall approve the destruction of the restricted drug unless

Documents

Licensed Dealers

Method of recording information

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

Information — general

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

Destruction

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

Annual report

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

Non-renewal or revocation within first three months

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

Non-renewal or revocation after third month

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

Institutions

Method of recording information

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

Information

J.01.083 An institution shall record the following information:

Drug Received for Identification and Analysis

Method of recording information

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

Information

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

Record Keeping

Retention period

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

Location

J.01.087 The documents shall be kept

Quality of documents

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

Notification of Application for Order of Restoration

Written notification

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

Content of notification

(2) The notification shall specify

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

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

Coming into Force

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