Canada Gazette, Part I, Volume 152, Number 25: Regulations Amending the Narcotic Control Regulations (Licences and Permits)

June 23, 2018

Statutory authority
Controlled Drugs and Substances Act

Sponsoring department
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the regulations.)

Issues

The legislative and regulatory framework in Canada for controlled substances has evolved over decades to address emerging issues and meet international commitments under the United Nations drug control conventions. As a result, some of the regulations under the Controlled Drugs and Substances Act (CDSA) are relatively recent while others are far older. The Narcotic Control Regulations (NCR), for example, first came into force in 1961 under the Narcotic Control Act (the legislation that preceded the CDSA), while the Benzodiazepines and Other Targeted Substances Regulations (BOTSR) only came into force in 2000.

This evolution has resulted in a set of regulations that, while containing broadly similar provisions, also feature several issues, gaps and inconsistencies regarding the issuance of licences and permits under the NCR and the BOTSR, as well as the Food and Drug Regulations, Part G (FDR-G), and the Food and Drug Regulations, Part J (FDR-J). The key issues, gaps and inconsistencies in terms of the licence and permit scheme set out in these regulations include

In addition, inconsistencies in the overall structure of these regulations result in a lack of clarity and potential confusion, leading to administration and compliance problems. For example, while there are provisions requiring permits for import and export of controlled substances in the NCR, the FDR-G and the FDR-J, there are no provisions in these regulations outlining the permit application and issuance process similar to those in the BOTSR. Instead, the permit application and issuance process for the NCR, the FDR-G and the FDR-J has been established by Health Canada via policy.

Notwithstanding amendments made over the years to the above-noted regulations, particularly since the enactment of the CDSA, these and other issues, gaps and inconsistencies have remained unaddressed. As a result, challenges have arisen with respect to the administration of these regulations and in compliance by licensed dealers, including undue administrative burden and unnecessary confusion or misunderstanding of certain provisions of the regulations.

Background

The CDSA is the federal statute that provides a legislative framework for the control of substances that can alter mental processes and that may cause harm to the health of an individual or to society when diverted or misused. Among other things, the CDSA enables the Governor in Council to make regulations with respect to authorizing legitimate activities with the substances controlled under the CDSA, particularly (although not exclusively) through the issuance of licences and permits.

The CDSA is the means by which Canada fulfills its obligations under the United Nations Single Convention on Narcotic Drugs, 1961 (1961 Convention), the Convention on Psychotropic Substances, 1971 (1971 Convention), and the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 (1988 Convention). These conventions form the basis for the current global drug control system and require the signatories to, among other things, place controls on legitimate activities with controlled substances conducted by authorized persons or businesses.

The CDSA prohibits any person from conducting activities such as the production, sale and provision, importation and exportation of controlled substances unless authorized by regulation or specifically exempted by the Minister of Health. The CDSA also specifies the range of penalties associated with the conduct of illegal activities with controlled substances.

When the CDSA was enacted in 1996, it set out a new legislative framework for controlled substances by repealing the Narcotic Control Act and Part III and Part IV of the Food and Drugs Act. Since then, changes have been made to various provisions of the CDSA and to some of its regulations in order to address emerging issues and to allow Canada to meet its international obligations under the United Nations drug control conventions.

The following regulations under the CDSA contain provisions for the issuance, by the Minister of Health, of licences and permits authorizing certain activities with controlled substances,footnote 1 including their production, import and export:

Objectives

The objectives of this regulatory proposal are

Description

The majority of the proposed amendments relate to provisions regarding the issuance of licences and permits. In particular, these amendments

Licences and permits

Overall, the current provisions with respect to licences and permits in the NCR, the BOTSR, the FDR-G and the FDR-J would be replaced with modernized and harmonized provisions, drafted in accordance with the current legal drafting convention. More specifically, the licence and permit part would have a completely different structure in comparison with the current regulations and would include added headings for every level of the regulations. This approach would clearly identify the process involved in the application for, and the issuance of, licences and permits as well as requirements for licensed dealers.

The following headings would be included:

Each of these headings would include subheadings addressing particular aspects. The heading for licences, for example, would include the following subheadings:

While the above-noted modifications would make requirements and conditions pertaining to the issuance of licences and permits easier to understand, this regulatory proposal would also make the following substantive changes to the licence and permit scheme in these regulations.

Issuance of licences and permits

Requirements for licensed dealers

The proposed amendments introduce the following new substantive requirements for licensed dealers:

The proposed regulatory amendments also add a provision in the NCR, the BOTSR, the FDR-G and the FDR-J regarding partial protection from self-incrimination for a licensed dealer who reports an incident of loss or theft to law enforcement that leads to a criminal investigation.

Addressing public health and safety issues

Given the risk to public health and safety caused by the diversion and misuse of controlled substances, the proposed regulations would authorize the Minister to add, modify or remove any terms or conditions in a licence at a time other than licence issuance, amendment or renewal.

Consequential and other amendments

The proposed regulations also amend numerous definitions and provisions in other parts of these regulations either as consequential amendments or as a result of applying the current legislative drafting convention for greater clarity and readability. The proposed regulations would also repeal provisions relevant to inspectors, as the CDSA was amended in 2017 to include more detailed provisions regarding inspections.

"One-for-One" Rule

The "One-for-One" Rule would apply and this proposal would be an "OUT" for the purpose of controlling administrative burden, as the proposed regulatory modifications would result in an overall reduction in administrative burden on affected industry stakeholders. The reduction in administrative burden cost would be banked and the administrative credits used to offset administrative burden costs imposed by other regulations implemented under the health portfolio.

Once the proposed amendments are implemented, a number of activities that are resulting in administrative burden on industry stakeholders would either no longer be required or would be reduced, resulting in an overall reduction in administrative burden and related costs. The changes in administrative burden are discussed in detail in the "Benefits and costs" section; essentially, impacted business licensed dealers would see benefits over the 10-year period of analysis for the following reasons:

It is assumed that completing the activities mentioned above usually involves someone with a technical or scientific background, such as a QPIC or an A/QPIC, and someone at management level, such as a SPIC. The time spent or avoided in relation to these activities is valued using average wage rates of $28.76 and $53.45 per hour (adjusted for overhead and in 2012 dollars) for QPIC and SPIC respectively.

As per the requirements of the Red Tape Reduction Act and the Red Tape Reduction Regulations, the reduction in administrative burden costs for all affected industry stakeholders is estimated over a 10-year period (2019–2028) and discounted to 2012 using a 7% real discount rate. The annualized net cost savings to licensed dealers are estimated to be $53,140 or $225 per licensed dealer.

Small business lens

The small business lens does not apply to this regulatory proposal, as the proposal would decrease costs to all businesses, including small businesses.

Consultation

A notice to interested parties was published in the Canada Gazette, Part I, on May 23, 2015, outlining the proposed key changes to the NCR, the BOTSR, the FDR-G and the FDR-J described above. Feedback from stakeholders in response to this notice was very positive. Concerns were raised by key stakeholders during a subsequent targeted meeting regarding a newly proposed record-keeping and reporting requirement, but the requirement has not been included in this regulatory proposal.

It should be noted that while the notice also signalled Health Canada's intent to make certain amendments to the Precursor Control Regulations (PCR), the Department subsequently decided that the PCR will be the subject of a stand-alone regulatory review in the future. Therefore, the present regulatory initiative targets the NCR, the BOTSR, the FDR-G and the FDR-J only.

Rationale

The evolution of the regulatory framework for controlled substances in Canada over the last few decades has resulted in a set of regulations that, while containing broadly similar parts and provisions, also feature a series of issues, gaps and inconsistencies related to provisions governing the issuance of licences and permits.

This has resulted in undue administrative burden and challenges to the implementation of these regulations. This regulatory proposal would rectify these issues, gaps and inconsistencies, and, in so doing, modernize the NCR, the BOTSR, the FDR-G and the FDR-J and improve the administration of, and compliance with, these regulations.

Benefits and costs

A cost-benefit analysis was conducted to estimate the impacts of the proposed amendments on the NCR, the BOTSR, the FDR-G and the FDR-J on potentially affected stakeholders (i.e. businesses, universities and research institutions, and the Government of Canada). All identified costs and benefits were assessed in incremental terms by considering changes that would only occur as a result of the proposed regulatory modifications.

It should be noted that some of the proposed requirements (e.g. submitting an annual report, reporting suspicious transactions, destroying remaining controlled substances, submitting a declaration after the completion of an importation/exportation or providing notification for the cessation of activities) would not result in any material incremental impacts on targeted stakeholders, since it is currently the practice for licensed dealers to undertake these activities.

The Government of Canada collects fees to process licence applications and renewals on a full cost-recovery basis. With the proposed extension of the licence validity period, the majority of the licences would not have to be renewed every year. For those licences that would not be renewed, the service that would have been associated with processing those applications would no longer be provided and the associated fees would not be collected. The reduction in fees collected would be offset by a reduction in processing costs and would therefore not constitute an incremental impact on the Government of Canada.

All impacts are quantified and monetized to the extent possible. Where this is not possible due to data limitations or lack of sufficient information, the impacts are described qualitatively. Together, the quantified and non-quantified impacts provide a more accurate picture of the costs and benefits to stakeholders and allow for an adequate assessment of the net impact of the proposed amendments.

All costs and benefits were estimated over a period of 10 years, from 2019 to 2028. This time period is considered long enough for all the costs and benefits to manifest themselves sufficiently.

All cost and benefit estimates are expressed in 2012 Canadian dollars (real monetary values).

A 7% real discount rate is used to estimate the present value (PV) of the incremental costs and incremental benefits and all values are discounted to 2018.

There were about 275 sites licensed to conduct activities with controlled substances (human or veterinary) in 2017. These sites are operated by businesses, research institutions, universities or government agencies. Among these sites, 236 are operated by businesses, 19 of which belong to small businesses. There is not enough historical data to observe the variations in the number of site licences over time; however, the number of licences in 2018 is similar to that of 2017. For this cost-benefit analysis, the number of licences is assumed to be constant over the analytical period.

Benefits

Benefits to businesses

Once the proposed amendments are made, business licensed dealers would see a number of benefits associated with a reduction in both compliance and administrative burden. The present value of the total benefit to businesses over the 10-year analytical period is estimated to be $6.70 million (or $954,250 annually).

Increasing the maximum licence validity period

Extending the maximum licence validity period from one year to three years in the BOTSR would harmonize this provision in all four regulations and would provide significant benefit to licensed dealers, as the frequency of renewing a licence could be reduced from once every year to once every three years. Due to the proposed amendments, Health Canada would make policy and operational adjustments when determining the validity period of a licence based on certain factors such as the compliance history of a licensed dealer. Health Canada estimates that 95% of licences (i.e. 224 licences) would receive a three-year validity period. These licensed dealers would enjoy both administrative burden cost savings as well as financial savings in the form of avoided payment of fees for two of the three years for which the licences are valid. Given the estimated time that will not be spent preparing a licence renewal application (1.5 hours, i.e. 1 hour for a QPIC and 0.5 hour for a SPIC) combined with the associated criminal record checks and the licensing fees that would not be paid, licensed dealers would save $5.18 million (PV) in costs (or $737,880 annually).

Removing the requirements on individuals authorized to place an order

The proposed amendments would remove the requirement that a business provide, in its licence application, the name of the individuals authorized to place an order as well as the requirement that businesses submit an application to amend the list of "individuals authorized to place an order." Licensed dealers would benefit from these regulatory changes as they would no longer need to spend time filling in and submitting the "Application for changes affecting personnel in charge" form (20 minutes, i.e. 15 minutes for a QPIC or an A/QPIC and 5 minutes for a SPIC) to have the list of individuals authorized to place an order updated whenever there is a change in personnel. In 2017, 226 submissions from businesses with respect to changes in personnel were received by Health Canada. Among them, 66% (149 amendment submissions) contained changes regarding individuals authorized to place an order. Assuming the number of such requests remains unchanged over time, it is estimated that the proposed amendments would save the industry $11,500 (PV) or $1,640 annually.

Expansion of educational and professional criteria for QPIC or A/QPIC

Licensed dealers would benefit from broadening the scope of acceptable educational and professional qualifications for a QPIC or A/QPIC. It is assumed that licensed dealers whose routine business consists of non-science-based activities such as wholesale or distribution do not necessarily require a QPIC or A/QPIC to hold a scientific or similar degree and would benefit most from the proposed amendments. These licensed dealers would be able to designate an employee with other types of educational backgrounds (e.g. training as pharmacy technician, qualification in supply chain management) earning lower wages to be a QPIC or A/QPIC. In 2017, there were approximately 60 licensed dealers engaged only in wholesale or distribution of controlled substances. It is assumed that once the proposed amendments come into force, these companies would assign the QPIC or A/QPIC function to an employee earning a lower wage. As a result of the change in personnel, these businesses would save about $1.32 million in PV (or approximately $187,810 annually).

Removing the annex to the licences

Currently, licensed dealers that make or assemble products or compounds containing controlled substances have to apply for a licence amendment to reflect in the annex to the licence any changes to requisite information (e.g. brand name, strength per unit) regarding these products and compounds. In 2017, 38% of licence amendment applications (62 applications) were submitted to make changes to the licences' annexes. Given the absence of historical data on trends, this number is assumed to remain constant over time. Removing the annex to the licence and requiring instead a notification to the Minister in relation to these types of changes would eliminate the need for licence amendments. This change would provide benefits to affected licensed dealers as it would reduce the administrative burden they face, and at the same time eliminate the potential delay licensed dealers may face in conducting their activities while waiting for the licence amendment to be processed. When accounting for the time it would normally take to submit a notification to the Minister, around 15 minutes (10 minutes for a QPIC or A/QPIC and 5 minutes for a SPIC) would be saved by licensed dealers by not having to apply for a licence amendment. The associated administrative burden cost savings to licensed dealers is estimated to be approximately $3,850 in PV (or $550 annually).

Extending permit validity period

The proposed amendments would extend the validity period of import and export permits to up to 180 days. Some licensed dealers have indicated that insufficient permit validity length has prevented them from completing their import or export transactions. This has resulted in these licensed dealers not being able to use the permits, and in most of these cases, having to reapply for a permit.

On average, 23% of permits granted in 2016 and 2017 were not used. Licensed dealers had reapplied for 63% of the unused permits at a later date within the same year in order to complete the same transaction. It is not possible to determine with a large degree of certainty the number of permits that were not used and had to be reapplied for solely because of the length of the permit validity period. However, it is reasonable to assume that in 90% of the cases, the permits were not used because the validity period had expired. These regulatory amendments would benefit licensed dealers as they would reduce the risk of delay in completing their import or export transaction and would eliminate the additional administrative burden associated with reapplying for a permit (45 minutes to prepare the application: 30 minutes for a QPIC or A/QPIC and 15 minutes for a SPIC). The resulting administrative burden cost savings to impacted licensed dealers is estimated to be approximately $185,265 in PV (or $26,380 annually).

Benefits to private laboratories, researchers and research institutions

Universities and other research institutions that hold a dealer's licence would also benefit from the proposed amendments to provisions regarding the licence validity period and the individuals authorized to place an order. Currently, there are 25 laboratories and research institutions, including 19 universities, holding dealers' licences. As per the risk-based approach, it is expected that 95% of them (about 24) would see a reduction in administrative burden as they would no longer have to renew their licences every year or amend their list of individuals authorized to place an order. These licensed dealers would save a total of 1 285 hours over 10 years. These reductions in time spent and the avoided fees would translate into savings of $45,850 in PV over 10 years (or $6,530 annually).

Benefits to the Government

There are 14 government institutions (departments, agencies and laboratories) conducting activities with controlled substances. These activities include supplying controlled substances to third parties or conducting forensic laboratory work. These government licensed dealers would benefit from the proposed expansion of a licence validity period in the form of time saved as they would only need to renew a licence once every three years. Considering the time it normally takes to fill in a licence application, the proposed amendments would save them 145 hours over 10 years.

Health Canada would also benefit from the proposed amendments. The expected reduction in the number of submissions received by Health Canada in relation to permit reapplications would result in time savings. This time savings would total 4 840 hours over 10 years.

The total time saved by the Government would translate into savings of $130,030 in PV over 10 years (or $18,510 annually).

The reduced burden on government resources would also provide benefits in that the available resources would be used to ensure and likely further improve services provided by the Department under the controlled substances licensing and permitting regime, for example, by meeting the service standards for licence and permit issuance with a higher percentile.

Allowing the Minister to impose conditions on a licence at a time other than at issuance, renewal or amendments would enable her to take timely actions to address areas of risk where controlled substances could be diverted to illicit markets and uses. Formalizing the reporting of suspicious transactions, and requiring the reporting of losses and thefts on a particular timeline would enhance the capacity of the Minister to identify any trend or instance of diversion attempts and take necessary enforcement actions, thereby increasing the overall effectiveness of the controlled substances regime.

Health and safety benefits

There would be additional non-quantifiable benefits to Canadians as the Minister would be able to add, modify or remove terms and conditions on a licence (at a time other than at issuance, amendment or renewal) in order to protect public health and safety if activities are suspected to be taking place contrary to the regulations or are suspected to negatively impact the health and safety of Canadians.

Costs

Cost to businesses, researchers and research institutions

Regulated parties (businesses, researchers and research institutions) would need to thoroughly review the updated provisions to understand the changes in order to ensure compliance with the regulations. Researchers and research institutions would spend 90 hours and industry stakeholders would spend 825 hours to review and understand the proposed regulatory modifications. As a result, the affected stakeholders would bear a cost of $26,035 in PV over 10 years (or $3,705 annually).

Cost to the Government

The Government is not expected to incur any material incremental cost as a result of the proposed amendments.

Limited compliance promotion activities would be undertaken to raise awareness about the modernized regulatory language and the formalized requirements related to reporting. However, given that the licensed dealers are already reporting losses and thefts, suspicious transactions and cessation of activities, these compliance promotion activities would be very limited and conducted as part of normal activities under the controlled substances program.

Finally, there would be no change in the manner in which the regulatory requirements are enforced. As a result, no new funding would be required.

Net impacts

Overall, all of the affected licensed dealers are expected to see a reduction in administrative and/or compliance burden due to these proposed amendments. While the proposed amendments would create some costs, the net impact is expected to be positive. The total net benefit of the proposed amendments over the 10-year period would amount to $6.85 million (or $975,590 annually). The Department would also see its services improved (for example by meeting its service standards in areas where they are currently not adequately met), resulting in reduced costs to businesses as they would be able to conduct their activities in a more timely fashion.

Cost-benefit statement
A. Quantified impacts
(rounded to 000's, in 2012$)
2019 2021 2023 2028 Total (2019–2028) Total
(2019–2028) (PV)
Annualized Average
Undiscounted Discounted to 2018
A1. Industry
Benefits (cost savings)
Increased length of licences' validity period 1,040.08 0.00 1,114.17 1,215.44 7,850.05 5,182.56 737.88
Removal of licences' annexes 0.59 0.59 0.59 0.59 5.87 3.85 0.55
Removal of the requirements regarding individuals authorized to place an order 1.75 1.75 1.75 1.75 17.51 11.50 1.64
Extension of permit validity period 20.07 23.46 27.51 41.55 295.22 185.26 26.38
Expansion of educational and professional criteria for QPIC and A/QPIC 200.96 200.96 200.96 200.96 2,009.59 1,319.11 187.81
Total benefits 1,263.44 226.76 1,344.98 1,460.28 10,178.24 6,702.28 954.25
Costs
Reviewing the regulatory modifications −26.95 0.00 0.00 0.00 −26.95 −23.54 −3.35
Net benefits 1,236.49 226.76 1,344.98 −1,460.28 10,151.29 6,678.74 950.90
A2. Research institutions
Benefits (cost savings)
Increased length of licences' validity period 9.69 0.00 9.69 9.69 67.81 45.24 6.44
Removal of the requirements regarding individuals authorized to place an order 0.09 0.09 0.09 0.09 0.92 0.61 0.09
Total benefits 9.78 0.09 9.78 9.78 68.73 45.85 6.53
Costs
Reviewing the regulatory modifications −2.85 0.00 0.00 0.00 −2.85 −2.49 −0.36
Net benefits 6.92 0.09 9.78 9.78 65.88 43.35 6.17
A3. Federal government
Benefits (cost savings)
Reduction in volume of applications and other activities 14.49 15.99 19.55 29.13 206.84 130.03 18.51
Overall net benefit 1,257.91 242.84 1,374.32 1,499.19 10,424.01 6,852.12 975.59
B. Non-quantified impacts
B1. Benefits to Government The Department would be able to improve the services it provides, for example by meeting the service standards for licence and permit issuance with a higher percentile.
B2. Benefits to public health and safety Formalizing certain activities, in addition to being able to impose conditions on a licence, would allow the Minister to take appropriate actions to prevent diversion of controlled substances to illicit markets and uses, thereby protecting public health and safety.

Implementation, enforcement and service standards

There are no additional service standards other than those that already exist for issuing licences and permits. Since the proposed amendments aim to further improve the administration of and the compliance with these regulations, it would be expected that the service standards for licence issuance, amendment, renewal and permit issuance would be improved as a result of the proposed amendments.

Contact

Markes Cormier
Healthy Environments and Consumer Safety Branch
Health Canada
Main Stats Building
150 Tunney's Pasture Driveway
Ottawa, Ontario
K1A 0K9
Email: OCS_regulatorypolicy-BSC_politiquereglementaire@hc-sc.gc.ca

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 Narcotic Control 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 Narcotic Control Regulations (Licences and Permits)

Amendments

1 The long title of the Narcotic Control Regulations footnote 2 is replaced by the following:

Narcotic Control Regulations

2 Section 1 of the Regulations and the heading before it are repealed.

3 The heading before section 2 and sections 2 to 29 of the Regulations are replaced by the following:

Definitions

Definitions

2 (1) The following definitions apply in these Regulations.

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

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

cannabis means the substance set out in item 17 of the schedule. (chanvre indien)

cannabis medical document has the meaning assigned by the definition medical document in subsection 1(1) of the Access to Cannabis for Medical Purposes Regulations. (document médical concernant le chanvre indien)

cannabis oil has the same meaning as in subsection 1(1) of the Access to Cannabis for Medical Purposes Regulations. (huile de chanvre indien)

common-law partner, in relation to an individual, means a person who is cohabiting with the individual in a conjugal relationship, having so cohabited for a period of at least one year. (conjoint de fait)

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 narcotics into or from the country. (autorité compétente)

compound includes a preparation. (composé)

designated criminal offence means

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

diacetylmorphine (heroin) includes the salts of diacetylmorphine. (diacétylmorphine (héroïne))

dried marihuana has the same meaning as in subsection 1(1) of the Access to Cannabis for Medical Purposes Regulations. (marihuana séchée)

former Marihuana for Medical Purposes Regulations means the regulations made by Order in Council P.C. 2013-645 of June 6, 2013 and registered as SOR/2013-119. (ancien Règlement sur la marihuana à des fins médicales)

former Marihuana Medical Access Regulations means the regulations made by Order in Council P.C. 2001-1146 of June 14, 2001 and registered as SOR/2001-227. (ancien Règlement sur l'accès à la marihuana à des fins médicales).

fresh marihuana has the same meaning as in subsection 1(1) of the Access to Cannabis for Medical Purposes Regulations. (marihuana fraîche)

health care practitioner has, except in section 59, the same meaning as in subsection 1(1) of the Access to Cannabis for Medical Purposes Regulations. (praticien de la santé)

hospital means a facility

immediate container means the container that is in direct contact with the narcotic. (contenant immédiat)

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

licensed dealer means the holder of a licence issued under section 10.1. (distributeur autorisé)

licensed producer has the same meaning as in subsection 1(1) of the Access to Cannabis for Medical Purposes Regulations. (producteur autorisé)

marihuana means the substance referred to as "Cannabis (marihuana)" in subitem 17(2) of the schedule. (marihuana)

methadone includes the salts of methadon. (méthadone)

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

narcotic means, subject to subsection (2), a controlled substance set out in the schedule. (stupéfiant)

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

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)

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

qualified person in charge means the individual designated under subsection 9.2(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 9.1. (responsable principal)

test kit means a kit

transfer means, except in subsection 45(3), to transfer, whether directly or indirectly, without consideration. (transférer)

verbal prescription narcotic means a narcotic that is contained in medication that may be prescribed verbally and that has the following characteristics:

Exception

(2) Despite subitem 2(2) of the schedule, the following are not narcotics for the purposes of these Regulations:

Possession

Authorized persons

3 (1) A person is authorized to possess a narcotic if the person has obtained the narcotic 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 narcotic, and the person

Agent or mandatary

(2) A person is authorized to possess a narcotic 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 narcotic if

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 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 must

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

6 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

7 The Minister shall cancel the registration number for a test kit if

Licensed Dealers

Authorized Activities

General

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

Qualified person in charge present

(2) A licensed dealer may conduct an activity in relation to a narcotic 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 in order to import or export a narcotic.

Possession for export

(4) A licensed dealer may possess a narcotic for the purpose of exporting it if they have obtained it in accordance with these Regulations or the Access to Cannabis for Medical Purposes Regulations.

Marihuana — production

(5) A licensed dealer may cultivate, propagate or harvest marihuana only for scientific purposes.

Opium poppy — production

(6) A licensed dealer may cultivate, propagate or harvest opium poppy only for scientific purposes.

Licences

Preliminary Requirements

Eligible persons

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

Senior person in charge

9.1 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 narcotics that are specified in the licence application. The applicant may designate themself if the applicant is an individual.

Qualified person in charge

9.2 (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 narcotics that are specified in the licence application and for ensuring that those activities comply with these Regulations and the Access to Cannabis for Medical Purposes 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

9.3 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

10 (1) A person who intends to conduct an activity referred to in section 8 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 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 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

10.1 Subject to section 10.4, 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

10.2 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 16 or 17.

Return of licence

10.3 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

10.4 (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 (i) 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 narcotic 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

11 (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 10(1) and (2)..

Signature and attestation

(2) An application must

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

11.1 (1) Subject to section 11.4, 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 10.

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

11.2 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 16 or 17.

Return of previous licence

11.3 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

11.4 (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 (i) 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 narcotic 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

12 (1) Before making a change affecting any information referred to in section 10.1 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 10 that are relevant to the proposed amendment.

Signature and attestation

(2) The application must

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

12.1 (1) Subject to section 12.4, 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

12.2 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 16 or 17.

Return of previous licence

12.3 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

12.4 (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)(f) 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 narcotic 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

13 (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 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

13.1 (1) Subject to section 13.2, 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

13.2 (1) The Minister shall refuse to approve the change if

Exceptions

(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, these Regulations and the Access to Cannabis for Medical Purposes 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 narcotic 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

14 (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 10(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

14.1 A licensed dealer shall notify the Minister in writing as soon as feasible of

Notice — next business day

14.2 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

14.3 (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 10(1)(f) is being changed and shall be accompanied by the revised version of the list.

Notice of cessation of activities

14.4 (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

15 (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 narcotic 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

15.1 (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

15.2 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

16 (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 narcotic 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

17 (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 narcotic 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

17.1 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

18 (1) A licensed dealer shall submit to the Minister, before each importation of a narcotic, 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 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

18.1 Subject to section 18.4, on completion of the review of the import permit application, the Minister shall issue to the licensed dealer an import permit that contains:

Validity

18.2 An import permit is valid until the earliest of

Return of permit

18.3 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

18.4 (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

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

Declaration

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

Suspension

19 (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

20 (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 17(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 narcotic 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

20.1 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

21 (1) A licensed dealer shall submit to the Minister, before each exportation of a narcotic, 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 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

21.1 Subject to section 21.4, on completion of the review of the export permit application, the Minister shall issue to the licensed dealer an export permit that contains

Validity

21.2 An export permit is valid until the earliest of

Return of permit

21.3 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

21.4 (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

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

Declaration

21.6 The holder of an export permit shall provide the Minister, within 15 days after the day of export of the narcotic specified in the permit, with a declaration that contains the following information:

Suspension

22 (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

23 (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 17(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 narcotic 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

23.1 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

24 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 narcotics, including product labels, orders, shipping documents, invoices and advertising.

Sale and Provision of Narcotics

Sale to licensed dealer

25 A licensed dealer may sell or provide a narcotic to another licensed dealer.

Sale to pharmacist

25.1 (1) Subject to subsection (2), a licensed dealer may sell or provide to a pharmacist any narcotic other than dried marihuana.

Exception — pharmacist named in notice

(2) A licensed dealer shall not sell or provide to a pharmacist who is named in a notice issued under subsection 48(1) the narcotics 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 49 in respect of a pharmacist named in a notice issued under subsection 48(1).

Sale to practitioner

25.2 (1) Subject to subsections (2) to (4), a licensed dealer may sell or provide to a practitioner any narcotic other than diacetylmorphine (heroin) or dried marihuana.

Exception — heroin

(2) A licensed dealer may sell or provide diacetylmorphine (heroin) to the following practitioners:

Midwife, nurse practitioner or podiatrist

(3) For the purpose of subsections (1) and (2) a licensed dealer may sell or provide a narcotic to a midwife, nurse practitioner or podiatrist only if that practitioner is permitted to prescribe or possess the narcotic, 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 notice

(4) A licensed dealer shall not sell or provide to a practitioner who is named in a notice issued under subsection 59(1) the narcotics referred to in the noticeunless the licensed dealer has received a notice of retraction issued under section 60.

Provision to hospital employee

25.3 (1) Subject to subsection (2), a licensed dealer may provide to a hospital employee any narcotic other than dried marihuana.

Exception — heroin

(2) A licensed dealer may provide diacetylmorphine (heroin) to a hospital employee only if that hospital provides care or treatment to persons.

Sale to exempted person

25.4 (1) Subject to subsection (2), a licensed dealer may sell or provide a narcotic to a person who is exempted under section 56 of the Act with respect to the possession of that narcotic.

Exception — heroin

(2) A licensed dealer may sell or provide diacetylmorphine (heroin) only to a person who is exempted under section 56 of the Act with respect to the possession of that narcotic for a scientific purpose.

Sale to licensed producer

25.5 A licensed dealer may sell or provide cannabis to a licensed producer.

Written order

25.6 A licensed dealer may sell or provide a narcotic under sections 25 to 25.5 if

Verbal order

25.7 (1) A licensed dealer may sell or provide a verbal prescription narcotic under sections 25 to 25.5 if

Receipt

(2) A licensed dealer who receives 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 narcotic to the pharmacist or practitioner in accordance with a further verbal order received from them until after obtaining the receipt.

Packaging and Transportation

Packaging — sale and provision

26 (1) A licensed dealer who sells or provides a narcotic, other than a preparation described in section 36, 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 narcotic 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 narcotic and that has a registration number.

Transport

26.1 (1) A licensed dealer shall, in taking delivery of a narcotic that they have imported or in making delivery of a narcotic,

Exception

(2) A licensed dealer may have a verbal prescription narcotic transported by a common carrier.

Thefts, Losses and Suspicious Transactions

Protective measures

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

Theft or loss — licences and permits

27.1 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 — narcotics

27.2 A licensed dealer who becomes aware of a theft of a narcotic or of a loss of a narcotic that cannot be explained on the basis of normally accepted business activities shall

Explainable loss — narcotics

27.3 A licensed dealer who becomes aware of a loss of a narcotic 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

27.4 (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 narcotic 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

27.5 A report made under any of sections 27.1 to 27.4, 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

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

Application for approval

27.7 (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 narcotic:

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

27.8 On completion of the review of the application, the Minister shall approve the destruction of the narcotic unless

Documents

Method of recording information

28 A licensed dealer shall 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

28.1 A licensed dealer shall record the following information:

Verbal prescription narcotic

28.2 A licensed dealer who receives a verbal order for a verbal prescription narcotic and sells or provides it to a pharmacist, a practitioner or a hospital employee shall immediately record

Destruction

28.3 A licensed dealer shall record the following information concerning any narcotic that they destroy at the site specified in their licence:

Annual report

28.4 (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

29 (1) A licensed dealer or former licensed dealer shall keep any document containing 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

(2) The documents must be kept

Quality of documents

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

4 Paragraphs 31(2)(b) and (c) are replaced by the following:

5 Paragraphs 32(d) and (e) of the Regulations are replaced by the following:

6 Section 34 of the Regulations is replaced by the following:

34 Subject to section 39, a pharmacist may dispense a verbal prescription narcotic on receipt of a verbal prescription or order given by a person whom the pharmacist has taken reasonable precautions to determine is a practitioner.

7 (1) Paragraph 35(1)(a) of the Regulations is replaced by the following:

(2) Paragraphs 35(1)(b) and (c) of the French version of the Regulations are replaced by the following:

8 Sections 37 to 39 of the Regulations are replaced by the following:

37 A pharmacist shall not use an order or prescription, to dispense a narcotic after the quantity of the narcotic specified in the order or prescription has been dispensed.

38 If, in accordance with a written order or prescription, a pharmacist dispenses a narcotic, other than dextropropoxyphene, the pharmacist shall immediately enter in a book, register or other record maintained for such purposes

39 A pharmacist shall, before dispensing a verbal prescription narcotic in accordance with a verbal order or prescription, make a written record of it that sets out

9 Subsection 40(1) of the Regulations is replaced by the following:

40 (1) A pharmacist shall maintain a special narcotic prescription file in which shall be filed in sequence as to date and number all written orders or prescriptions for narcotics dispensed and the written record of all verbal prescription narcotics dispensed in accordance with a verbal order or prescription.

10 Section 46 of the Regulations is replaced by the following:

46 The Minister shall provide in writing any factual information about a pharmacist that has been obtained under the Act, these Regulations or the Access to Cannabis for Medical Purposes Regulations to the provincial professional licensing authority that is responsible for the registration and authorization of the person to practise their profession

11 (1) Paragraph 48(2)(c) of the Regulations is replaced by the following:

(2) Paragraphs 48(3)(b) and (c) of the Regulations are replaced by the following:

(3) Paragraph 48(5)(a) of the Regulations is replaced by the following:

(4) Subparagraph 48(5)(c)(ii) of the Regulations is replaced by the following:

12 Subparagraph 49(b)(ii) of the Regulations is replaced by the following:

13 Paragraphs 54(1)(a) and (b) of the Regulations are replaced by the following:

14 Section 57 of the Regulations is replaced by the following:

57 (1) The Minister shall provide in writing any factual information about a practitioner that has been obtained under the Act, these Regulations, the Access to Cannabis for Medical Purposes Regulations, the former Marihuana for Medical Purposes Regulations or the former Marihuana Medical Access Regulations to the provincial professional licensing authority that is responsible for the registration and authorization of the person to practise their profession

(2) The Minister is authorized to provide, in respect of a practitioner of medicine who made a medical declaration that formed the basis for the issuance of an authorization to possess under the former Marihuana Medical Access Regulations, the following information to the provincial professional licensing authority that is responsible for the registration and authorization of persons to practise medicine in the province identified in the declaration as the province in which the practitioner is authorized to practise:

15 (1) Paragraph 59(2)(c) of the Regulations is replaced by the following:

(2) Paragraph 59(3)(c) of the Regulations is replaced by the following:

(3) Paragraphs 59(4)(b) to (e) of the Regulations are replaced by the following:

(4) Paragraph 59(5)(a) of the Regulations is replaced by the following:

(5) Subparagraph 59(5)(c)(ii) of the Regulations is replaced by the following:

(6) Paragraph 59(6)(a) of the French version of the Regulations is replaced by the following:

16 Subparagraph 60(b)(ii) of the Regulations is replaced by the following:

17 Subparagraph 63(a)(v) of the French version of the Regulations is replaced by the following:

18 Subsection 65(6) of the French version of the Regulations is replaced by the following:

(6) La personne à qui est confiée la charge d'un hôpital peut permettre qu'un stupéfiant soit fourni à des fins de recherche à la personne qui est employée dans un laboratoire de recherche de cet hôpital et qui bénéficie d'une exemption relative à la méthadone et accordée en vertu de l'article 56 de la Loi.

19 Sections 68 to 70 of the Regulations are replaced by the following:

68 (1) Despite anything in these Regulations, a person may, for the purpose of identification or analysis of a narcotic, provide or deliver it to

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

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

69 Every person who is exempted under section 56 of the Act with respect to the possession of a narcotic — other than a person to whom a narcotic has been administered, sold, delivered or provided by a practitioner of medicine who is exempted under section 56 of the Act from the application of any subsection of section 53 with respect to that narcotic —, every practitioner of medicine who has received a narcotic under subsection 68(1) or (2) and every agent or mandatary of a practitioner of medicine who has received a narcotic under subsection 68(1) shall

70 No person shall

20 Section 71 of the Regulations is repealed.

21 Section 72 of the Regulations is replaced by the following:

72 (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.

(2) The notification shall specify

22 Sections 73 and 74 of the Regulations are replaced by the following:

73 (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)

(2) The Minister may provide to a nursing statutory body any information concerning any member of that body obtained under these Regulations, the Act or the Access to Cannabis for Medical Purposes Regulations.

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

74 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.

23 The French version of the Regulations is amended by replacing "praticien de la médecine" with "médecin" in the following provisions:

Consequential Amendments

Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations

24 Paragraph (b) of the definition dealer's licence in section 1 of the Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulationsfootnote3 is replaced by the following:

Industrial Hemp Regulations

25 The definition competent laboratory in section 1 of the Industrial Hemp Regulationsfootnote4 is replaced by the following:

competent laboratory means a laboratory that is owned or operated by a person who is a licensed dealer under section 10.1 of the Narcotic Control Regulations, or a laboratory outside Canada that is recognized as a qualified laboratory, for the application of the United Nations' Single Convention on Narcotic Drugs, 1961, as amended from time to time, by the competent authorities of the country in which it is located. (laboratoire compétent)

Precursor Control Regulations

26 Paragraph 6.1(a) of the Precursor Control Regulationsfootnote5 is replaced by the following:

Fees in Respect of Drugs and Medical Devices Regulations

27 Paragraphs (a) and (b) of the definition dealer's licence in subsection 29(1) of the Fees in Respect of Drugs and Medical Devices Regulationsfootnote6 are replaced by the following:

28 Subsection 31(3) of the Regulations is replaced by the following:

Timing of payment

(3) Subject to subsection (4), the fee is payable at the time of submitting the application for a dealer's licence or for the renewal of a dealer's licence under section 10 or 11 of the Narcotic Control Regulations or section G.02.006 or G.02.011 of the Food and Drug Regulations.

Access to Cannabis for Medical Purposes Regulations

29 (1) Subparagraph 112(a)(i) of the Access to Cannabis for Medical Purposes Regulationsfootnote7 is replaced by the following:

(2) Subparagraph 112(a)(ii) of the French version of the Regulations is replaced by the following:

30 Paragraph 176(2)(a) of the Regulations is replaced by the following:

Coming into Force

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