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Posted 26 August 2015 | By Rachelle D'Souza
Following is a free preview of a Regulatory Focus feature article, normally exclusively available to RAPS members. For information about becoming a member, visit Join RAPS. This article presents an overview of Canada's medical marijuana regulations regarding individual prescription access and compliance measures for licensed producers.
The narcotic marijuana (spelled "marihuana" in most official Canadian government communications) is not an approved drug or medicine in Canada. The Canadian government does not endorse marijuana's use due to its potential for serious public health, safety and security risks. However, because the courts required reasonable access to a legal marijuana source when authorized by a healthcare practitioner, the Canadian government introduced Marihuana for Medical Purposes Regulations (MMPR)1 in June 2013.
MMPR allows Health Canada-licensed commercial industry to produce, sell and distribute dried marijuana under secure and sanitary conditions to Canadians who have been authorized by healthcare professionals to possess dried marijuana for medical purposes.2 The Controlled Drugs and Substances Act (CDSA) prohibits possession, trafficking, import and export and production of controlled substances, including marijuana, unless authorized by these regulations.
When individuals access medical marijuana under MMPR (Figure 1), law enforcement agencies may need proof of their legal possession of dried marijuana. This proof can include the label on the marijuana package containing the individual’s specific client information or a separate document containing the same information in the shipment of marijuana.
While not a product monograph or representation of its conclusions on marijuana, Health Canada has prepared a summary document3 from peer-reviewed literature and international reviews discussing the endocannabinoid system, clinical pharmacology, dosing, potential therapeutic uses, precautions, warnings, overdose and toxicity of cannabis (marijuana) and cannabinoids. The document supports healthcare professionals authorizing individual access to marijuana and is intended to complement other reliable sources of information. Health Canada also has provided healthcare professionals with a sample authorization document to provide to eligible medical marijuana patients.4
Marijuana and cannabis producers may be individuals or corporations and may conduct activities (Table 1) provided they are licensed (Figure 2) and conduct activities in accordance with their license (MMPR Division 2). However, compliance controls are required to become a licensed producer and subsequently to maintain the license in accordance with MMPR. To illustrate, below are some key controls required for compliance, which is evaluated through the presence of adequate procedures and records in a quality system:
Possess, Produce, Sell, Provide, Ship, Deliver, Transport, Destroy
- Sale or provision may be to another licensed producer, licensed dealer, Health Canada or a person to whom an exemption relating to the substance has been granted under CDSA Section 56.
- Dried marijuana may be sold or provided to producer’s client or an individual responsible for that client, a hospital employee, if the possession of the dried marijuana is for the purposes of and in connection with their employment, or a person to whom an exemption relating to the dried marijuana has been granted under CDSA Section 56.
- Licensed producers may ship dried marijuana to healthcare practitioners who authorize medical documents.
Cannabis, Other Than Marijuana
Marijuana producers must comply with MMPR Division 3, which includes general security measures and security measures for the perimeter of a site and areas within a site where cannabis is present. The Directive on Physical Security Requirements for Controlled Substances additionally establishes minimum security compliance standards for the storage of controlled substances. It applies to dried marijuana, marijuana seeds and cannabis used solely for the purpose of conducting in vitro testing to determine the percentages of cannabinoids in dried marijuana (packaged and unpackaged).
There are several good production practices specified by MMPR Division 4. For instance, a lot or batch must be released for sale by a designated Quality Assurance (QA) person with appropriate expertise. Lot or batch release is dependent upon various precursory measures for which QA exercises oversight. These include analytical testing for microbial and chemical contaminants and for percentages of delta-9-tetrahydrocannabinol and cannabidiol. Analytical test results for contaminants must be within acceptable limits of recognized international publications, such as pharmacopoeia. All analytical test methods must be validated and test protocol records and test result reports for test and reference standards or controls must be retained.
Pest control products used to treat marijuana before, during or after the drying process should have been assessed and registered by the Pest Management Regulatory Agency (PMRA). Pest control products must not exceed the maximum residue limit specified for the product under the Pest Control Products Act. Premises, equipment and personnel involved in dried marijuana production, packaging, labeling and storage must comply with a sanitation program to prevent contamination. The sanitation program must include personnel health, hygiene and apparel. Licensed producers are to have a system in place for rapid recall, with recall reporting to Health Canada within three days. Serious adverse reactions also must be reported within 15 days of becoming aware of the reaction. Licensed producers also must maintain a concise, critical analysis of all adverse reactions in an annual summary report, for provision to Health Canada within 30 days of their request.
Under MMPR Division 5, there must be various packaging, labeling and shipping controls implemented by licensed producers for quality assurance. For instance,
As shown in Figure 2, producers are required to comply with local laws and notify their local government, local police force and local fire officials of their intention to apply to Health Canada for licensing so these authorities are aware of their proposed location and activities. Licensed producers also are required to communicate with local authorities whenever there is a change in the status of their license.
Canada is a signatory to the Single Convention on Narcotic Drugs, 1961 as amended by the 1972 Protocol, the Convention on Psychotropic Substances, 1971, and the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988.5 Health Canada is obligated to control marijuana movement in a manner consistent with these international drug control conventions, which strictly limit marijuana trade among countries to medical and scientific purposes and to confirmed quantity estimates of the International Narcotics Control Board6. Therefore, under Canadian law, medical marijuana is not permitted to be imported from or exported to foreign markets where recreational use is legal. However, permits are considered under certain circumstances, such as importing starting materials for a new licensed producer or exporting a unique marijuana strain for scientific investigation in a foreign laboratory. Importation and exportation of medical marijuana, under MMPR Division 6, requires filing import and export permit applications.
Public complaints about licensed producers that may not be complying with the requirements of MMPR should be sent to Health Canada at CMC@hc-sc.gc.ca.
The Supreme Court of Canada made a decision (case R v. Smith, 11 June 2015)7 authorizing individuals who possess marijuana under MMPR and those falling under the terms of a court injunction (for example, Allard injunction8) to possess marijuana derivatives, such as cannabis oil, for their own use. This is in addition to dried marijuana currently permitted under MMPR. Therefore, to enable an immediate legal supply of cannabis oil and fresh marijuana (buds and leaves, excludes plant material used to propagate marijuana), Health Canada issued the following CDSA Section 56 Class Exemptions:
These Section 56 Class Exemptions build on the regulatory requirements of MMPR and its model for medical marijuana access through healthcare professional authorization, while setting out additional or pertinent compliance requirements to cannabis oil and fresh marijuana, such as special provisions for labeling, quantity and a supplemental license. Licensed producers must continue complying with all MMPR provisions as Health Canada inspection activities can include verification against MMPR and the Section 56 Class Exemption.
Today, Canada has a regulated commercial industry to ensure quality production of and controlled access to medical marijuana. The medical marijuana industry needs to be vigilant to ensure regulatory compliance, especially as legislative requirements continue to evolve.
Rachelle D'Souza entered the scientific affairs arena in 2007 and has since supported multinational and start-up companies in the biopharma, consumer care, medical device, cosmetic and food industries with their global compliance needs. D’Souza is CEO of Regulatory Heights Inc., a consulting corporation that offers cost effective regulatory, quality, clinical, pharmacovigilance and medical information services to corporations and other entities in the global medical supply chain. She can be reached at email@example.com.
Cite as: D’Souza R. “Canada’s Marijuana for Medical Purposes Regulations (MMPR)—An Overview.” Regulatory Focus. August 2015. Regulatory Affairs Professionals Society.
Tags: marijuana, medical marijuana, Canada, Health Canada
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