Policy on Health Canada's Supply of Marihuana Seeds and Dried Marihuana for Medical Purposes

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Table of Contents

1. Effective Date
2. Context
3. Definitions
4. Scope
5. Purpose
6. General Obligations
7. Eligibility
8. Ordering Process
9. Payments
10. Returns
11. Enquiries
12. Adverse Reactions
13. References

1. Effective Date

The Policy on Health Canada's Supply of Marihuana Seeds and Dried Marihuana for Medical Purposes (the Policy) came into effect December 3, 2003. The Policy has been revised as of November 30, 2009 to incorporate amendments to the ordering and payment process (section 9).

2. Context

Cannabis (marihuana) is included in Schedule II of the Controlled Drugs and Substances Act, thus making all related activities including, possession, production, importation, exportation, trafficking and possession for the purposes of trafficking marihuana illegal in Canada unless authorized by regulation.

Marihuana is not an approved therapeutic product as it has not been assessed by Health Canada for safety, efficacy and quality as required under the Food and Drugs Act and the Food and Drug Regulations.

The Marihuana Medical Access Regulations (MMAR) came into effect on July 30, 2001. The objective of the MMAR is to provide seriously ill persons residing in Canada with a means to obtain an authorization to possess marihuana and/or a licence to produce marihuana for medical purposes.

Further to court decisions that took place in 2003, Health Canada was mandated to provide a framework under the MMAR for authorized persons to gain access to a legal supply of marihuana seeds and/or dried marihuana for medical purposes. This was undertaken so that authorized persons would not have to use the illicit market. In December 2003, Health Canada released the Policy, which provides the framework by which authorized persons can access Health Canada's supply of marihuana seeds and/or dried marihuana for medical purposes.

3. Definitions

For the purposes of this Policy, the following terms are understood to have the same meaning as stated in the MMAR but are set out below for convenient reference:

• "authorization to possess" means an authorization to possess dried marihuana issued under section 11.
• "designated person" means the person designated, in an application made under section 37, to produce marihuana for the applicant.
• "dried marihuana" means harvested marihuana that has been subjected to any drying process.
• "licence to produce" means either a personal-use production licence or a designated-person production licence.
• "licensed dealer" means the holder of a licence issued under section 9.2 of the Narcotic Control Regulations.
• "marihuana" means the substance referred to as Cannabis (marihuana) in subitem 1(2) of Schedule II to the Controlled Drugs and Substances Act.
• "medical practitioner" means a person who is authorized under the laws of a province to practice medicine in that province and who is not named in a notice given under section 59 of the Narcotic Control Regulations.

4. Scope

This Policy applies:

• in respect of dried marihuana, to persons who are authorized by Health Canada to possess marihuana for medical purposes; and
• in respect of marihuana seeds, to persons who are holders of a licence to produce marihuana for medical purposes as authorized by Health Canada.

5. Purpose

The objective of this Policy is to ensure that persons who are authorized by Health Canada to possess marihuana for medical purposes have reasonable access to a legal source of supply. It defines the eligibility requirements and the process by which persons can access marihuana seeds and/or dried marihuana produced by a licensed dealer under contract with Her Majesty in right of Canada.

This Policy also establishes the prices and methods of payment for marihuana seeds and dried marihuana that authorized persons can purchase from Health Canada.

This Policy will be evaluated on an ongoing basis with consideration for a number of factors, including: emerging medical and scientific data concerning the use of marihuana for medical purposes; availability of new, approved cannabinoid or THC-based drug products in Canada; Canada's policies related to controlled substances; and, amendments to the legislation (see section 13) supporting this Policy.

6. General Obligations

Persons authorized to possess marihuana for medical purposes and holders of a licence to produce marihuana for medical purposes must adhere to the following general obligations. At any given time, they must:

• not have more dried marihuana and/or marihuana plants in their possession than they are allowed, as specified in their authorization to possess or licence to produce;
• maintain the measures necessary to ensure the security of the dried marihuana and/or marihuana plants in their possession;
• ensure that they abide by all other applicable federal, provincial and municipal legislation, including but not limited to legislation restricting smoking in public places; and
• not sell, provide or traffic any of the dried marihuana, marihuana plants and/or marihuana seeds that are in their possession.

7. Eligibility

Prior to ordering dried marihuana and/or marihuana seeds from Health Canada, persons must hold an Authorization to Possess and/or a Licence to Produce marihuana for medical purposes from Health Canada.

7.1 Authorization

An Authorization to Possess marihuana for medical purposes is issued, in accordance with the MMAR, to persons for whom conventional therapies are inappropriate or ineffective, provided that they have the support of their medical practitioner.

A Licence to Produce limited quantities of marihuana is issued, in accordance with the MMAR, to the holder of an authorization to possess marihuana or to the person designated to produce marihuana on behalf of the holder of an authorization to possess marihuana.

Persons who wish to apply for an Authorization to Possess or a Licence to Produce marihuana for medical purposes under the MMAR may contact Health Canada or visit the website. Details are found in section 11 of this Policy.

8. Ordering Process

8.1 Application

Authorized persons who want to obtain access to Health Canada's supply of dried marihuana must submit to Health Canada an "Application to Obtain Dried Marihuana" (Form E1).

Authorized persons who want to obtain access to Health Canada's supply of marihuana seeds must submit to Health Canada an "Application to Obtain Marihuana Seeds" (Form E2).

Authorized persons who want to obtain both Health Canada's supply of marihuana seeds and an interim supply of dried marihuana must submit both Form E1 and Form E2 to Health Canada.

These forms are available on the internet at www.healthcanada.gc.ca/mma or alternatively, on request from Health Canada.

A complete application must include a signed applicant declaration stating the applicant:

• has read the contents of section 4 of Form E1or Form E2 titled "Notice to Applicants" and acknowledges that the benefits and risks associated with the use of the product are not fully understood, and that the use of the product may involve risks to health that are not known;
• understands that the safety and effectiveness of the product have not been assessed by Health Canada; and
• understands Health Canada is not giving any assurances, warranties or approvals with regard to the marihuana seeds or dried marihuana being provided.

Health Canada will review each application received to determine whether the applicant meets the eligibility criteria identified above, and whether all required information has been included as per the MMAR.

Once an application has been reviewed and approved by Health Canada, an approval letter will be sent to the applicant informing them that they can now purchase dried marihuana and/or a supply of marihuana seeds from Health Canada. Payment and ordering information will be included with the approval letter. Shipments of dried marihuana and/or marihuana seeds will be made only upon receipt and processing of full payment for the requested order.

8.2 Ordering and Distribution

8.2.1 Dried Marihuana

The maximum quantity of dried marihuana that may be purchased will be determined based on the daily amount proposed by the medical practitioner in the "Medical Practitioner's Form" (Form B1 or B2) submitted with the application for an authorization to possess. Dried marihuana will be supplied in the quantity supported by the physician to the authorized person for approximately 30 days (e.g., 5g per day x 30days = 150g per month). Health Canada will not ship a quantity of dried marihuana in excess of the maximum monthly quantity that an authorized person has authority to possess.

Dried marihuana will be shipped by courier or, in remote locations, by Canada Post, to the authorized person, unless the authorized person has arranged for their medical practitioner to receive the dried marihuana on their behalf and has so-indicated in Form E1. If this is the case, it is the responsibility of the authorized person to ensure that their medical practitioner agrees to receive shipments of product on their behalf.

The following information and documentation will be included with every shipment of dried marihuana:

• technical information about its characteristics (e.g., THC concentration, strain, etc.) and guidance regarding proper storage; and
• a document titled "Information About the Use of Marihuana for Medical Purposes" which provides guidance and warnings about the use of marihuana for medical purposes.

8.2.2 Marihuana Seeds

Marihuana seeds may be purchased from Health Canada on a one-time-only basis. Should additional seeds be required, the holder of a licence to produce would need to submit a new application stating why additional seeds are required along with a new signed applicant declaration.

The number of marihuana seeds to be supplied will be determined based on the maximum number of marihuana plants the holder of a licence to produce has been authorized for. The ratio is three seeds for one plant. Marihuana seeds will be shipped by courier or, in remote locations, by Canada Post, to the holder of a licence to produce.

The following information and documentation will be included with every shipment of marihuana seeds:

• technical information about the maternal lineage of the marihuana seeds (i.e., characteristics of the maternal batch lot such as approximate THC concentration, morphological characteristics, seed viability, female to male ratio, etc.); and
• a document titled "Information About the Use of Marihuana for Medical Purposes" which provides guidance and warnings about the use of marihuana for medical purposes.

8.2.3 Marihuana Seeds and Interim Supply of Dried Marihuana

An interim supply arrangement will be made available on a one-time only basis. Should additional seeds and/or a second interim supply of dried marihuana be required, authorized persons must submit a new application (Form E1 and E2) stating why additional product is required, along with a new signed applicant declaration.

Marihuana seeds may be purchased as specified in section 8.2.2 of this Policy. An interim supply of dried marihuana may be purchased for up to four months, as specified in section 8.2.1 of this Policy. The interim supply of dried marihuana should allow sufficient time for a first crop to be harvested from the marihuana seeds purchased. The interim supply is based on an estimated 90 to 100 day grow cycle.

The following information and documentation will be included with every shipment of marihuana seeds and dried marihuana:

• technical information about the maternal lineage of the marihuana seeds (i.e., characteristics of the maternal batch lot such as approximate THC concentration, morphological characteristics, seed viability, female to male ratio, etc.);
• technical information about the characteristics of the dried marihuana (e.g., THC concentration, strain, etc.) and guidance regarding proper storage; and
• a document titled "Information About the Use of Marihuana for Medical Purposes" which provides guidance and warnings about the use of marihuana for medical purposes.

9. Payments

Authorized persons approved to access Health Canada's supply of marihuana seeds and/or dried marihuana are required to pay in advance for all products ordered and supplied under the provisions of this Policy.

Instructions regarding payment methods and applicable taxes will be included when an approval to receive Health Canada's supply of marihuana seeds and/or dried marihuana is issued.

Authorized persons and/or holders of a licence to produce who have an account in arrears but wish to continue purchasing Health Canada's supply of marihuana seeds and/or dried marihuana are required to set up a payment arrangement plan prior to placing any further orders.

An amount owing to the Government of Canada is considered a debt to the Crown. In the case of a non-payment of an account, the Receiver General of Canada has authority to recover any amounts owing in a manner consistent with the provisions of the Financial Administration Act.

10. Returns

Health Canada will reimburse authorized persons or holders of a licence for unopened packages of marihuana seeds and/or dried marihuana that are returned to Health Canada. Authorized persons or holders of a licence will not be reimbursed for any and all opened packages, even if returned to Health Canada.

11. Enquiries

Enquiries related to this Policy should be directed to Health Canada:

Marihuana Medical Access Division
Controlled Substances and Tobacco Directorate
Health Canada
Address Locator: 3503B
Ottawa ON K1A 1B9
Telephone: 1-866-337-7705
Website: www.healthcanada.gc.ca/mma

12. Adverse Reactions

Authorized persons and medical practitioners are asked to report any serious or unexpected reactions to dried marihuana by notifying Health Canada by contacting the Canada Vigilance Program:

Canada Vigilance Program
Marketed Health Products Safety and Effectiveness Information Bureau
Marketed Health Product Directorate
Health Products and Food Branch
Health Canada
Address Locator: 0701D
Ottawa ON K1A 0K9
Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789
Email: CanadaVigilance@hc-sc.gc.ca
Website: www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php

13. References

13.1 Pertinent Legislation

• Controlled Drugs and Substances Act
• Food and Drugs Act
• Food and Drug Regulations
• Marihuana Medical Access Regulations
• Narcotic Control Regulations
• Marihuana Exemption (Food and Drugs Act) Regulations
• Financial Administration Act

13.2 Other Information Sources

A document entitled "Information for Health Care Professionals" containing information on the use of marihuana for medical purposes is available on the Health Canada website or upon request. This document can be found at the following link: www.hc-sc.gc.ca/dhp-mps/marihuana/how-comment/medpract/infoprof/index-eng.php