Applying to Become a Licensed Producer under the proposed Marihuana for Medical Purposes Regulations

NOTICE: It will not be possible to apply to become a licensed producer until the proposed Marihuana for Medical Purposes Regulations come into effect. The proposed regulations and the guidance documents outlined below are all in a draft form and are subject to change based on the comments received during the 75-day comment period, which will end on February 28, 2013.  

To legally possess, sell, provide, ship, deliver, transport and/or destroy, produce, export and/or import marihuana for medical purposes under the Marihuana for Medical Purposes Regulations, interested parties would have to apply to Health Canada to become a licensed producer.

What you should know:

To obtain a producer's licence from Health Canada, interested individuals or corporations would have to demonstrate compliance with the requirements outlined in the proposed  Marihuana for Medical Purposes Regulations.

Further proposed guidance documents are outlined for consideration:

Product Quality

The proposed regulations would provide access to quality-controlled marihuana for medical purposes to Canadians who need it. Therefore, licensed producers would be subject to good production practices that are meant, among other things, to ensure the cleanliness of the premises and equipment. The licensed producer would also be required to employ a quality assurance person with appropriate training, experience, and technical knowledge to approve the quality of dried marihuana prior to making it available for sale.

Licensed producers would also have to test dried marihuana for microbial and chemical contaminants.  The draft Technical Specifications for Dried Marihuana for Medical Purposes guidance document provides specific information for licensed producers who intend to produce dried marihuana for medical purposes so that they can meet these requirements. 

The  Food and Drugs Act (FDA) would apply to licensed producers

• Marihuana must not be produced under unsanitary conditions;
• Marihuana must not be adulterated;
• There is a prohibition on labelling, packaging, selling or advertising in a manner that is false, misleading or deceptive.

Security

Production sites would only be located indoors, and not in a private dwelling.  This would reduce the risks of diversion posed by outdoor production and the health and safety risks associated with producing marihuana in a private dwelling.

Health Canada's existing Directive on Physical Security Requirements for Controlled Substances establishes security requirements for the storage of all controlled substances.  These requirements are scaled to the illicit market value of the controlled substance and to the crime rates in various areas. This directive would apply to the storage of dried marihuana by licensed producers.

The proposed regulations also set out physical security requirements that would be necessary to secure sites where licensed producers conduct activities with marihuana. The draft Guidance Document: Building and Production Security Requirements for Marihuana for Medical Purposes provides technical details on how to meet these security requirements.

All applicants for a producer's licence would have to demonstrate to Health Canada that they meet these security requirements.  Licensed producer sites would be subject to compliance and enforcement measures, including regular audits and Government inspections. 

Consumer Information

Dried marihuana would have to be packaged in a tamper-evident and child-resistant container, and contain standard information about the product (for example, the weight in grams, the packaging date, the expiry date). In addition, all licensed producers would be required to attach a client-specific label, similar to a patient-specific prescription drug label, to the package of dried marihuana. The label would also include the shipping date and the anticipated date of delivery to the registered client.

Under the proposed regulations, each package of dried marihuana sold to a client would need to be accompanied by a copy of the most current version of the Health Canada document entitled "Information on the Use of Marihuana for Medical Purposes". This document indicates that the safety and efficacy of dried marihuana for medical purposes has not been established.  It provides a summary of the known information about the uses and risks of marihuana for medical purposes so that individuals could be informed about their treatment choice.

Interested in Applying to Become a Licensed Producer?

See the proposed  Marihuana for Medical Purposes Regulations for full details on proposed application and licensing requirements.

Applications to become a licensed producer will not be accepted until the regulations are promulgated. This is anticipated for spring 2013.  An application form and guidance on the application process will be made available in advance of the promulgation of the final regulations.

Get the application form: Licence Application To Become a Licensed Producer under the Marihuana for Medical Purposes Regulations. (Release date to be determined)

You will also need the Guidance Document for the Licence Application To Become a Licensed Producer under the Marihuana for Medical Purposes Regulations as a reference tool to help you in your application. (Release date to be determined)

Interested parties planning on applying to become licensed producers can work with Health Canada now to apply for an authorization to conduct certain research and development activities with marihuana such as testing marihuana plant materials and growing conditions on-site.