ARCHIVED - Issuance of Licences to Produce Marijuana for Medical Purposes - Information Bulletin
To Licensed Producers of Marijuana for Medical Purposes and Applicants
The purpose of this information bulletin is to explain the process for the initial issuance of a licence, including limits on licensed activities and a maximum limit on the total amount of marijuana authorized for production, for applicants who successfully meet the requirements of the Marihuana for Medical Purposes Regulations (MMPR) to become a licensed producer, as well as the process for seeking to amend or renew licences.
The Controlled Drugs and Substances Act (CDSA) and its regulations serve the dual purposes of protecting public health and maintaining public safety. The CDSA is also the means by which Canada fulfills its international obligations to, among other things, prevent the diversion and abuse of narcotic drugs by controlling and limiting their use for medical and scientific purposes. Consistent with these purposes, the MMPR created a system whereby individuals with a medical need may access dried marijuana for medical purposes that has been produced under quality-controlled, sanitary, and secure conditions.
The MMPR were promulgated to enable access to marijuana for medical purposes for individuals in Canada who have a demonstrated medical need and who have the support of a healthcare practitioner. For the purposes of protecting public health and maintaining public safety, Health Canada takes measures to prevent risks of diversion and to verify that the dried marijuana being supplied meets the standards of the MMPR. Consequently, the process for issuing and amending licences includes a number of safeguards described below.
Application to Become a Licensed Producer
Section 23 of the MMPR lists all of the information which must be included in the licence application. Health Canada will examine all of the required information and documents, and if necessary, may seek additional information from the applicant. Required security clearances also have to be granted before a licence can be issued. For more information, visit the Department's Security Clearance Process web page.
All applications to become a licensed producer of marijuana for medical purposes undergo a strict and rigorous review. Each application is assessed on a case-by-case basis and in accordance with the regulatory requirements.
Health Canada issues licences that list the permissible activities which can be undertaken by a licensed producer, and which may contain certain additional conditions. Licences may be issued for a term of up to three years.
Licensed producers may apply to renew or amend their licences under sections 28 or 29 of the MMPR.
It should be noted that a licence will not be issued, renewed or amended when there are grounds to refuse it as described in section 26 of the MMPR. For example, Health Canada will not issue, renew or amend a licence when it is likely to create a risk to public health, safety or security, including the risk of cannabis being diverted to an illicit market or use.
For more information, visit the Application Process web page.
Health Canada is monitoring the quality of the marijuana being produced by all licensed producers, and in particular those newly licensed producers entering the market. When a producer is first licensed, they are typically issued a production-only licence. This graduated approach is for the purpose of verifying that the marijuana meant for registered clients meets all of the quality standards set out under the MMPR.
Once a licensed producer has finished producing the first crop of marijuana, they must demonstrate through an inspection and test results that the planned growing processes will result in the production of a dried product that meets the licensed producer's specified quality control standards and the Good Production Practices set out in Division 4 of the MMPR. Only once Health Canada is satisfied the licensed producer meets the requirements of Division 4 of the MMPR will a licence be amended to allow sale to the public.
Approved Production Amounts
Health Canada also controls the amount of marijuana produced by licensed producers of marijuana for medical purposes. Production limits help avoid the potential for speculative production (i.e., production that is not based on client demand) that could create a risk to public health and safety, including the risk of marijuana being diverted to an illicit market or use.
Health Canada sets production limits on producer licences in consideration of various factors, including the production capacity of the facility, the number of security cleared personnel available to monitor areas where cannabis is present, licensed producer client base, and Canada's cannabis estimates confirmed by the International Narcotic Control Board. Health Canada may request additional information from the applicant or licensed producer to support the Department's determination of approved production amounts. A typical initial production limit would be 100 kg of dried marijuana in a three month period, representing the first growth cycle of the plant.
Renewal or Amendment of a Licence
At the request of the licensed producer, Health Canada may renew or amend the licence so that the producer can conduct a broader range of activities, including the sale of dried marijuana to registered clients or other licensed producers, and/or to increase production amounts.
In considering a request to amend a licence to increase the allowable production amount, Health Canada requires information to substantiate the request, such as the size and nature of the licensed producer's client base or the need to produce a broader range of strains.
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