Transitioning to a New Regime of Licensed Producers
Canada's Changing Medical Marijuana System - Since its introduction in 2001, Health Canada's Marihuana Medical Access Program (MMAP) has grown exponentially, from under 500 authorized persons to over 30,000 today. This rapid increase has had unintended consequences for public health, safety and security as a result of allowing individuals to produce marihuana in their homes. Under the new regulations, production will no longer take place in homes and
municipal zoning laws will need to be respected, which will further enhance public safety.
Effective April 1, 2014, Health Canada will no longer produce and distribute marihuana for medical purposes. The current Marihuana Medical Access Regulations (MMAR) will be repealed on March 31, 2014, when the new regime is fully implemented. Additional information on key dates will be provided to program participants and other stakeholders throughout the transition period.
The new Marihuana for Medical Purposes Regulations (MMAR) aim to treat marihuana as much as possible like other narcotics used for medical purposes. The regulations will provide access to quality-controlled marihuana for medical purposes, produced under secure and sanitary conditions, to those Canadians who need it.
Under MMAR, licensed marijuana producers must also abide by standards set in Good Manufacturing Practices (GMP), for pharmaceutical manufacturers ensuring a controlled, procedure-driven cultivation, processing and testing systems. For instance, if a question of safety or potency is raised, a licensed, GMP-compliant grower should be able to fully trace a specific product or dose, and answer concisely to the medical community and patients.
Health Canada provides licenses to medical marijuana producers who are inspected and found in compliance with applicable sections of the following Canadian acts and regulations:
To date, dried marihuana has not been authorized as a therapeutic product in Canada or in any other country. In addition, no international standards currently exist specifically for the quality of dried marihuana.
Dried marihuana produced by a LP, while exempt from the application of the Food and Drug Regulations via the Marihuana Exemption (Food and Drugs Act) Regulations other than in the context of marihuana to be used in a clinical trial, is subject to provisions in the Food and Drugs Act. This includes a general prohibition (paragraph 8(a) and (b)) against the sale of a drug that was "manufactured, prepared, preserved, packaged or stored under unsanitary conditions; or is adulterated".
Division 4 of the MMPR includes Good Production Practices (GPP) requirements relating to the premises, storage of dried marihuana, equipment, the sanitation program, standard operating procedures, recall of product, and quality assurance personnel. Additionally, the MMPR provide compliance and enforcement measures, allowing for refusal, suspension or revocation of a producer's licence on the basis of risks to public health, safety or security.
The specific regulatory requirements listed in section 5 of the Health Canada Guidance Document for Technical Specifications for Testing Dried Marihuana for Medical Purposes are applicable to finished dried marihuana which is to be sold or provided by a LP under the MMPR. They do not apply to live plants or to intermediate processing stages. The finished product requirements are also applicable to imported dried marihuana when it is to be sold or provided in Canada, and to Canadian-produced marihuana which is to be exported.