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Vol. 137, No. 26 — December 17, 2003

Registration SOR/2003-387 3 December, 2003

CONTROLLED DRUGS AND SUBSTANCES ACT

Regulations Amending the Marihuana Medical Access Regulations P.C. 2003-1908 3 December, 2003

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 55(1) of the Controlled Drugs and Substances Act (see footnote a) , hereby makes the annexed Regulations Amending the Marihuana Medical Access Regulations.

REGULATIONS AMENDING THE MARIHUANA MEDICAL ACCESS REGULATIONS

AMENDMENTS

1. Subsection 4(2) of the Marihuana Medical Access Regulations (see footnote 1) is replaced by the following:

(2) An application under subsection (1) shall contain

(a) a declaration of the applicant;

(b) a medical declaration that is made

(i) in the case of an application based on a category 1 symptom, by the medical practitioner of the applicant, or (ii) in the case of an application based on a category 2 or 3 symptom, by a specialist; and (c) two copies of a current photograph of the applicant.

2. (1) Paragraph 5(1)(e) of the Regulations is replaced by the following:

(e) that the authorization is sought in respect of marihuana to be

(i) produced by the applicant or a designated person, in which case the designated person must be named, or (ii) obtained from a medical practitioner under section 70 or obtained under section 70.1 from a licensed dealer producing marihuana under contract with Her Majesty in right of Canada; (2) Paragraph 5(1)(f) of the English version of the Regulations is replaced by the following:

(f) that the applicant is aware that no notice of compliance has been issued under the Food and Drug Regulations concerning the safety and effectiveness of marihuana as a drug and that the applicant understands the significance of that fact; and

3. Section 7 of the Regulations is repealed.

4. Section 8 of the Regulations is replaced by the following:

8. A medical declaration under section 6 must be dated and signed by the medical practitioner or specialist making it and must attest that the information contained in the declaration is correct and complete.

5. The portion of section 10 of the Regulations before paragraph (a) is replaced by the following:

10. The photograph required under paragraph 4(2)(c) must clearly identify the applicant and must

6. (1) Subsection 12(1) of the English version of the Regulations is amended by adding the word "or" at the end of paragraph (b) and by striking out the word "or" at the end of paragraph (c).

(2) Paragraph 12(1)(d) is repealed.

7. (1) Paragraph 14(1)(b) of the Regulations is replaced by the following:

(b) the material required under sections 4 to 10.

(2) Subsection 14(2) of the Regulations is replaced by the following:

(2) For the purpose of paragraph (1)(b), a photograph referred to in paragraph 4(2)(c) is required only with every second renewal application.

8. (1) Paragraphs 34(1)(d) and (e) of the Regulations are replaced by the following:

(d) subject to subsection (1.1), if the site specified in the licence where dried marihuana may be kept is different from the place where the person who applied for the licence ordinarily resides, to send or transport directly from that site to the place of residence a quantity of dried marihuana not exceeding the maximum quantity specified in the authorization to possess on the basis of which the licence was issued; and

(e) to provide or deliver to the person who applied for the licence a quantity of dried marihuana not exceeding the maximum quantity specified in the authorization to possess on the basis of which the licence was issued.

(2) Section 34 of the Regulations is amended by adding the following after subsection (1):

(1.1) A holder of a designated-person production licence sending dried marihuana under paragraph 34(1)(d) shall

(a) securely pack the marihuana in a package that

(i) prevents the contents from being identified without the package being opened, and (ii) is sealed so that the package cannot be opened without the seal being broken; and (b) use a method of sending that involves

(i) a means of tracking the package during transit, (ii) obtaining a signed acknowledgment of receipt by the holder of the authorization to possess, and (iii) safekeeping of the package during transit. (3) Subsection 34(2) of the Regulations is repealed.

9. (1) Paragraph 41(b) of the Regulations is repealed.

(2) Section 41 of the Regulations is amended by adding the following before paragraph (c):

(b.1) if the designated person would be the holder of more than one licence to produce; or

10. Section 54 of the Regulations is repealed.

11. The Regulations are amended by adding the following before section 55:

54.1 The holder of a licence to produce shall not produce marihuana in common with more than two other holders of licences to produce.

12. Section 56 of the Regulations and the heading before it are repealed.

13. Paragraph 62(2)(d) of the Regulations is replaced by the following:

(d) the photograph submitted under paragraph 4(2)(c) or section 14 as part of the application for the authorization or renewal is not an accurate representation of the holder of the authorization.

14. Section 70 of the Regulations and the heading before it are replaced by the following:

SUPPLY OF DRIED MARIHUANA

70. A medical practitioner who has obtained dried marihuana from a licensed dealer under subsection 24(2) of the Narcotic Control Regulations may provide the marihuana to the holder of an authorization to possess under the practitioner's care.

70.1 A licensed dealer, as defined in section 2 of the Narcotic Control Regulations, producing dried marihuana under contract with Her Majesty in right of Canada may provide or send that marihuana to the holder of an authorization to possess.

COMING INTO FORCE

15. These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Description

On October 7, 2003, the Ontario Court of Appeal issued its decision in the case of Hitzig et al. v. Her Majesty the Queen. The Court declared five provisions of the Marihuana Medical Access Regulations (MMAR) invalid in order to render the MMAR constitutionally acceptable.

The objective of this regulatory initiative is to give national effect to elements of the remedy imposed by the Ontario Court of Appeal by repealing certain provisions of the MMAR and to implement an alternative mechanism to provide for reasonable access to a legal supply of marihuana for medical purposes.

The Legislative Framework

The MMAR, which were promulgated on July 30, 2001, provide seriously ill persons residing in Canada with a process by which they can obtain an authorization to possess and a licence to produce marihuana for medical purposes, when conventional therapies have been unsuccessful. There are two main components to the MMAR: "authorization to possess" and "licence to produce".

An Authorization to Possess (ATP) marihuana for medical purposes is issued on compassionate grounds to patients based on the advice and support of their medical practitioner(s).

A licence to produce limited quantities of marihuana is issued to either the authorized person or a person who has been designated by the holder of an ATP to produce marihuana on that person's behalf. The maximum quantity permitted to be produced is based on the ATP holder's daily dosage.

As of November 7, 2003, 602 persons in Canada hold ATPs. In 384 of those cases, the ATP holders also hold a Personal-use Production Licence (PPL) which allows them to produce marihuana for their own medical needs. In 64 cases, a Designated-person Production Licence (DPL) has been issued allowing a designated person to produce marihuana for the authorized person who applied for the licence.

Decisions by the Courts

On January 9, 2003, Justice Sidney N. Lederman of the Ontario Superior Court, in the case of Hitzig et al. v. Her Majesty the Queen, declared that the MMAR were constitutionally invalid and of no force and effect on the basis that they failed to provide a legal supply of marihuana for persons authorized to possess it for medical purposes. All parties appealed the decision.

In response to the Lederman decision, and while awaiting the outcome of the appeal, in July 2003, Health Canada implemented the "Interim Policy for the Provision of Marihuana Seeds and Dried Marihuana Product for Medical Purposes in Canada" (the Interim Policy). The Interim Policy provides a framework for the legal supply and distribution of marihuana seeds and dried marihuana for medical purposes in Canada. In order to allow for a supply of dried marihuana under Health Canada's Interim Policy, a regulation to exempt marihuana produced under contract with Her Majesty in Right of Canada from the requirements of the Food and Drugs Act (FDA) and its regulations was necessary. The Marihuana Exemption (Food and Drugs Act) Regulations (MER) came into force on July 8, 2003.

The Ontario Court of Appeal (the court) heard the appeal of the Lederman judgment on July 29-31, 2003. The Government did not ask the court to pass judgment on the constitutionality of the MMAR as modified by the Interim Policy nor did it suggest that the Interim Policy should have any effect on the outcome of the appeal. The Interim Policy was put before the court only so that it would be aware of the current state of affairs.

The court issued its decision on October 7, 2003. It found that the MMAR did not provide for reasonable access to a legal supply of marihuana for medical purposes because some persons granted authorizations to possess marihuana under the MMAR were dependent on the illicit market as a source of supply for their medical needs. The court held that this made the MMAR constitutionally defective. In addition, it found that the requirement in the MMAR that some applicants have the support of a second specialist physician to establish medical need is unconstitutional. The court rectified the constitutional deficiencies it had identified by declaring invalid the following five provisions of the MMAR:

• the prohibition against compensating a holder of a DPL for growing marihuana and supplying it to the holder of an ATP (s. 34(2));

• the provision preventing a DPL holder from growing marihuana for more than one ATP holder (par. 41(b));

• the prohibition against a DPL holder producing marihuana in common with more than two other DPL holders (s. 54); and

• the two provisions requiring a declaration by a second specialist (par. 4 (2)(c)) and s. 7).

In its decision, the court made clear that the Government need not accept the remedy crafted by the court and could address the constitutional shortcomings identified in the MMAR with an alternative regulatory framework. The Government has therefore decided not to appeal the decision, but instead, to respond to the court decision by amending the MMAR and continuing to provide access to the government source of supply under the Interim Policy.

Amendments to the MMAR

In order to improve its marihuana for medical purposes program, in 2003, Health Canada initiated consultations with stakeholders, including patients, physicians, pharmacists and law enforcement agencies, to discuss the need for potential changes to the MMAR. A Stakeholder Advisory Committee on Medical Marihuana (SAC),which is comprised of persons authorized to possess marihuana for medical purposes, physicians, nurses, pharmacists, and law enforcement officials, was established. The consultation activities will continue into 2004.

To respond to the decision of the court issued in early October 2003 in a timely manner, amendments to the MMAR will now be carried out in two phases. The first phase focuses on the response to the court decision, giving national effect to certain elements of the remedy granted by the court, while providing an alternative approach that will afford reasonable access to a legal supply of marihuana for authorized persons. The second phase will involve a broader review of the MMAR to address issues expressed by stakeholders and will incorporate a comprehensive consultative process.

This first phase of amendments to the MMAR includes the following provisions:

(1) To give national effect to the elements of the court remedy with respect to the MMAR requirements for a second specialist declaration under Category 3:

• Repeal the requirement for a second specialist declaration in the case of persons who are seeking an authorization to possess under Category 3 found in paragraph 4(2)(c) and section 7.

This amendment is also consistent with input received from stakeholders during the consultation processes undertaken by Health Canada.

(2) To give national effect to the aspect of the court remedy related to allowing DPL holders to obtain consideration:

• Repeal of subsection 34(2) to remove the prohibition against obtaining consideration for any activities related to the production of marihuana for persons authorized to possess;

• Amendment of paragraph 34(1)(e) to add authority to "provide" marihuana to authorized persons, whether or not for consideration; and

• Amendment of the MER to add an exemption for marihuana produced by DPL holders.

Based on evidence before them, the court found that, having regards to the time and effort involved in the production of marihuana, authorized persons were unlikely to find volunteers to produce marihuana on their behalf.

In addition to repealing the existing prohibition in the MMAR against the DPL holder obtaining consideration, the MMAR must be amended to expressly permit the DPL holder to provide marihuana to the authorized person for consideration in order to prevent the DPL holder from falling within the prohibition against trafficking of marihuana in section 5 of the Controlled Drugs and Substances Act (CDSA).

Because marihuana for medical purposes meets the definition of a drug under the FDA, it is also necessary to exempt the marihuana produced by DPL holders from the requirements of the FDA and its regulations, which regulate the sale and distribution of drugs in Canada, in order to permit DPL holders to be remunerated for their production activities.

(3) To provide for reasonable access to a legal source of supply, inclusion in the Regulations of the option of obtaining dried marihuana from a licensed dealer under contract with Her Majesty in right of Canada, as set out in Health Canada's Interim Policy.

• Amendment of paragraph 5(1)(e) of the Regulations to reflect the availability of a Government supply of dried marihuana; and

• Addition of a provision in Part IV of the MMAR to enable the Government's supply of dried marihuana to be shipped directly to persons who hold an ATP marihuana for medical purposes.

The Government is committed to continuing to supply dried marihuana to persons authorized to possess marihuana for medical purposes, and marihuana seeds to persons authorized to produce marihuana, until such time as an alternate supply that satisfies the requirements of the FDA, the CDSA and their respective regulations is available.

Some medical practitioners have expressed concerns about receiving marihuana on behalf of their patients who are ATP holders, since there may be increased risks to the safety and security of medical offices. To address such concerns, the MMAR are amended to include authority for a licensed dealer who is producing marihuana on contract to the Government to supply the ATP holder directly. ATP holders will continue to have the option to access their supply of dried marihuana through their practitioner, if the latter is supportive of this arrangement.

Health Canada will continue discussions with pharmacists and provincial/territorial regulators of pharmacy practice regarding the possibility of establishing a mechanism whereby marihuana for medical purposes would be provided through pharmacies in due course.

The amendment of paragraph 5(1)(e), combined with amendments to Part IV of the MMAR, will clearly define the currently available legal sources of supply of marihuana for medical purposes. The Interim Policy, released on July 9, 2003, will be amended to reflect the Government's commitment to provide ongoing access to the Government's supply of dried marihuana.

(4) To maintain control over the production and distribution of marihuana in keeping with the principles of the CDSA and the FDA, and to maintain compliance with Canada's international obligations, the limits on the production of marihuana for medical purposes by DPL holders will be maintained:

• Paragraph 41(b) will be re-enacted to reinstate on a national basis, the limit on the number of persons for whom one designated person can produce marihuana; under the MMAR, one DPL holder can cultivate for only one ATP holder; and

• Section 54 will be re-enacted to reinstate on a national basis, the limit on the number of DPL holders who can produce marihuana in common; under the MMAR, a DPL holder is not permitted to produce marihuana in common with more than two other DPL holders.

These limits on the production of marihuana are necessary to:

- maintain control over distribution of an unapproved drug product, which has not yet been demonstrated to comply with the requirements of the FDA/FDR;

- minimize the risk of diversion of marihuana for non-medical use;

- be consistent with the obligations imposed on Canada as a signatory to the United Nations' Single Convention on Narcotic Drugs, 1961 as amended in 1972 (the 1961 Convention), in respect of cultivation and distribution of cannabis; and

- maintain an approach that is consistent with movement toward a supply model whereby marihuana for medical purposes would be: subject to product standards; produced under regulated conditions; and distributed through pharmacies, on the advice of physicians, to patients with serious illnesses, when conventional therapies are unsuccessful. Such a model would also include a program of education and market surveillance.

(5) To ease certain other restrictions on DPL holders in order to enhance access to marihuana produced by DPL holders

• Repeal of section 56 which requires DPL holders to keep records of their production activities; and

• Amendment of section 34 to allow shipment of dried marihuana by a DPL holder to an ATP holder under secure conditions. This will allow an ATP holder to designate a person who is known to the ATP holder but who lives outside the immediate community to grow on the ATP holder's behalf, when the latter is unable to find a designated person who lives close by.

These amendments will provide additional alternatives for ATP holders to obtain a legal supply of marihuana when they are unable to produce marihuana for themselves and choose not to access the dried marihuana produced on contract to the Government.

In addition to the foregoing, a number of technical, consequential amendments are effected to realign the remaining provisions in the MMAR with these changes.

The Government believes that these regulatory amendments, combined with the availability of the Government source of supply under the Interim Policy, satisfy the principles set out in the decision of the Ontario Court of Appeal in that they will provide for reasonable access to a legal source of supply and thus, ensure the constitutionality of the MMAR. At the same time, these amendments provide a framework that is consistent with the principles of the FDA and its regulations regarding limitations on the sale and distribution of a drug product until its safety, efficacy and quality have been demonstrated. Further, these amendments respect the principles underlying the CDSA and its regulations in respect of control over the distribution of controlled substances to ensure that they are used only for legitimate scientific and medical purposes to protect public health and safety.

Alternatives

The options outlined below provide an overview of the regulatory alternatives that were considered prior to the selection of Option 3.

Option 1: Give national effect to the Ontario Court of Appeal remedy in its entirety by repealing all the sections declared invalid.

The Government has no issue with repeal of the provisions of the MMAR with respect to the requirement for a declaration from a second medical specialist or the provision which restricts the ability of the holder of a DPL to obtain consideration. The removal of the limitations on production of marihuana are, however, viewed as being sufficiently problematic to be considered untenable.

Removing the limits on the number of holders of an ATP for whom a DPL holder can produce, and permitting the pooling of multiple DPLs, have the effect of expanding the production and distribution of marihuana to an extent which, when combined with the declaration of invalidity of the restriction on DPL holders from obtaining consideration, facilitates the development of commercial activity that would move Canada away from compliance with its international obligations under the United Nations 1961 Convention. Articles 23 and 28 of the convention require signatory countries who permit the cultivation of marihuana, to create a national government agency that has exclusive right on import, export, wholesale trade and maintenance of stocks of marihuana. Provisions within Article 23, as they apply to cannabis [marihuana], include obligations such as the requirement for all cultivators of marihuana to deliver their total crops of marihuana to the agency for distribution. The Government of Canada has been compelled by the courts to develop a system to provide for a legal supply of marihuana for medical purposes. In doing so, the Government has made every effort to implement a system that will meet its international obligations to the fullest extent possible. By permitting only limited production of marihuana by persons authorized to possess for medical purposes, or limited production of marihuana by a designated person on their behalf, that is carried out within the terms and conditions of their licences to produce, the supply of marihuana for medical purposes in Canada is not inconsistent with the intention of the Convention to prevent illicit trade in marihuana. To expand the number of ATP holders that a DPL holder can produce for beyond the current 1:1 ratio, would obligate the Government to implement a system to collect all marihuana produced in order to comply with the 1961 Convention.

The expanded production and distribution of marihuana that would result from removal of the existing limits in the MMAR also runs contrary to the intent of the FDA/FDR to restrict the sale and distribution of an unapproved, non-standardized drug product outside of the manufacturing processes and distribution channels authorized by the FDR. Further, larger marihuana grow operations, in the absence of more stringent requirements for security measures to protect plants and the harvested dried marihuana, would increase the risk of diversion of marihuana thereby posing greater challenges for law enforcement and greater risk to the public health and safety of Canadians. The Government would need to establish a significant administrative infrastructure to maintain regulatory surveillance over such grow operations in order to minimize the risk of diversion. In addition to the domestic concerns, it is anticipated that other countries would view this as a further relaxation of Canada's controls over marihuana and that they would express grave concerns with respect to the increased potential for cross-border diversion and resulting exacerbation of their own domestic drug abuse problems.

Option 2: Reinstate all provisions struck down by the Ontario Court of Appeal and appeal the court's decision.

The court decision left untouched the basic exemption scheme under the MMAR (i.e., authorizations to possess and licences to produce for medical purposes) and afforded the Government large discretion in implementing an alternate remedy to address the issue of reasonable access to a legal supply. The Government is addressing those aspects of the remedy it finds problematic by means of regulatory amendment and provision of marihuana from the Government source of supply under the Interim Policy, rather than by an appeal of the decision. The court decision provides useful guidance on how to strike the proper balance between the need to preserve and promote public health and safety of Canadians through controlled substances legislation, while respecting individuals' rights to access medical marihuana. For instance, removing the requirement for a second specialist declaration for persons seeking to be authorized within Category 3 and allowing consideration to be received by DPL holders, improve the MMAR framework and are consistent with input received to date from stakeholders.

Option 3: Implement regulatory changes as outlined in phase I of "Amendments to the MMAR".

This option gives national effect to the court-imposed remedy with respect to the two provisions that require a second specialist declaration in the case of applications under Category 3 and the provision prohibiting a DPL holder from obtaining consideration. It also respects the intent of the court decision by providing reasonable access to a legal supply of marihuana for medical purposes by entrenching the Government's Interim Policy and commitment to continue to provide marihuana for medical purposes into the Regulations. The amendments further help to facilitate access to marihuana for medical purposes by easing some of the restrictions on DPL holders, pending transition to a new supply model.

Option 3 was determined to be the preferred option. This option incorporates certain aspects of the court's remedy into the MMAR, while providing for reasonable access to a legal source of marihuana. In rendering its decision the court expressly left it open to the Government to develop an alternative mechanism to address the issue of legal supply of marihuana for medical purposes.

The identified regulatory amendments, combined with continued provision of marihuana seeds and dried marihuana by the Government, establish a legal means by which authorized persons can have reasonable access to marihuana for medical purposes in Canada, thereby addressing the constitutionality issues raised by the court. This revised framework offers a balance between facilitating access to a legal supply of marihuana for medical purposes and providing a level of protection against diversion and misuse of marihuana which is comparable to what currently exists under the MMAR. Further, it allows Canada to continue to meet its international obligations under the United Nations drug control conventions to the fullest extent possible.

Benefits and Costs

These regulatory amendments are expected to have an impact on the following sectors:

Public

Persons authorized or wishing to obtain an ATP marihuana for medical purposes will benefit from enhanced clarity around, and access to, the different options for a legal supply of marihuana. DPL holders will benefit from the easing of some of the requirements currently imposed on them.

Some persons may view the maintenance of restrictions on production by DPL holders as depriving them of the opportunity to develop a business or not-for-profit service to supply marihuana to persons authorized to possess. It was never the intent of the MMAR, which permits, on a compassionate basis, seriously ill persons to obtain an authorization to possess marihuana for medical purposes when conventional therapies have been unsuccessful, to give rise to any form of commercial supply network. The amendments will serve to maintain an appropriate level of control over the production and distribution of marihuana, as an unapproved drug, to minimize the risk of diversion and misuse and thereby protect the health and safety of the Canadian public.

Medical Practitioners

Medical practitioners have expressed concern about the risk to their personal and office security if they are the sole avenue for access to the Government supply of dried marihuana. These amendments will benefit medical practitioners by allowing a licensed dealer who produces marihuana on contract to the Government to supply authorized persons directly, thereby alleviating some of the pressures on the practitioners. Similarly, the removal of the requirement for the second specialist declaration for applicants in Category 3 takes into account the concerns expressed by the medical community and relieves some of the burden on the health care system.

Pharmacists

These amendments have no direct effect on pharmacists. They may, however, cause pharmacists to receive more questions from patients concerning the use of marihuana for medical purposes in light of Health Canada's communication of its intent to pursue the possibility of making marihuana for medical purposes available through pharmacies.

Law Enforcement Agencies

Law enforcement agencies will benefit from maintenance of the limits on the production of marihuana as a means to manage the risk of diversion and misuse of marihuana. No increase in enforcement costs associated with these amendments is expected although the number of persons licensed to produce marihuana under a DPL could increase.

Health Canada

Health Canada anticipates that it will be able to manage any additional workload within existing resources and is of the view that the benefits derived from these regulatory amendments in terms of ongoing protection of public health and safety, and compliance with international drug control conventions, outweigh the any additional costs that will be incurred. This initiative is expected to increase costs related to administration of the marihuana medical access program due to an anticipated increase in the number of applications for designated-person production licences, and requests for Government supplied dried marihuana.

Consultation

An exemption from pre-publication was requested in order for these Regulations amending the MMAR to be registered and published in the Canada Gazette, Part II (CGII) as soon as possible following the Ontario Court of Appeal decision (October 7, 2003) in the Hitzig case. Early registration was requested to:

- give national effect in a timely manner to certain elements of the remedy imposed by the Ontario Court of Appeal;

- protect public health and safety by ensuring that the production and distribution of marihuana for medical purposes occur within a regulatory framework aimed at minimizing the risk of diversion and misuse of marihuana as an unapproved drug; and

- continue to meet Canada's international commitments, particularly in respect of the United Nations' drug control conventions.

Early in 2003, Health Canada commenced consultations with various stakeholder groups regarding changes to the MMAR. These groups included:

- SAC as part of regular, ongoing consultations with this group;

- the Canadian Medical Association (CMA);

- representatives of Canadian pharmacists and their regulatory authorities; and

- law enforcement agencies and associations.

Following release of the Ontario Court of Appeal decision in Hitzig et al., Health Canada has undertaken further, more focused, discussions with stakeholder groups concerning the Department's plans for proceeding with changes to the MMAR using a two-phased approach, and concerning this regulatory initiative, in particular. Groups contacted included:

- the SAC;

- a working group of the SAC, convened specifically for the purpose of timely consideration of proposed regulatory change;

- the CMA; and

- representatives of law enforcement agencies.

Input received from the above-referenced discussions was considered by Health Canada when drafting these Regulations to go directly to CGII. When registration and CGII publication takes place, the stakeholder community and the public will be notified by mail, e-mail, and Web announcement.

Consultations for Phase II amendments to the MMAR are scheduled to continue early in 2004, and will involve all stakeholder groups mentioned above, plus broader consultation with representatives of authorized persons, licensed persons, and other Canadians likely to be affected by further changes to the MMAR.

Compliance and Enforcement

These regulatory amendments have no impact on existing compliance and enforcement mechanisms under the provisions of the CDSA and the MMAR as identified in the Regulatory Impact Analysis Statement published in the Canada Gazette, Part II, on July 4, 2001. Maintenance of the limits on the production of marihuana will avoid an increase in existing compliance and enforcement challenges and further strain on law enforcement and regulatory inspection programs.

Contact

Cynthia Sunstrum Drug Strategy and Controlled Substances Programme Healthy Environments and Consumer Safety Branch Address Locator: 3503D Ottawa, Ontario K1A 1B9 Telephone: (613) 946-0125 FAX: (613) 946-4224 E-mail: OCS_Policy_and_Regulatory_Affairs@hc-sc.gc.ca

Footnote a

S.C. 1996, c. 19

Footnote 1

SOR/2001-227

NOTICE: The format of the electronic version of this issue of the Canada Gazette was modified in order to be compatible with hypertext language (HTML). Its content is very similar except for the footnotes, the symbols and the tables.

 

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