The Marihuana for Medical Purposes Regulations will authorise the following key activities:
- The possession of dried marihuana by individuals who have the support of an authorised health care practitioner to use marihuana for medical purposes;
- The production of dried marihuana by licensed producers; and
- The sale and distribution of dried marihuana by licensed producers and hospitals to individuals who can possess it.
What are some of the regulatory requirements to become a licensed producer?
Very briefly, to become a licensed producer, you must meet all requirements of the new Marihuana for Medical Purposes Regulations, for example:
- Submitting a completed licensed producer application to Health Canada;
- Obtaining the proper personal security clearances;
- Meeting the physical security requirements for the cultivation and storage areas;
- Good production practises (facility, equipment, sanitation, quality assurance, analytical testing, storage and distribution);
- Packaging, labelling and shipping;
- Quality System requirements such as standard operating procedures and forms;
- Client ordering and client registration;
- Record keeping.
There are four major areas of expertise that will be needed for a successful application. Physical security requirements, visual monitoring and intrusion detection for restricted access areas such as grow areas, packaging, and laboratory. Good production practises, the building and production practices that allows marihuana to be produced, packaged, labeled and stored are designed, constructed and maintained in a manner that permits those activates to be conducted under sanitary conditions. Quality system requirements require 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. This includes finished product testing and the maintaining all other quality system documents required for a controlled substance. Finally there is record keeping and inventory controls, these will include client ordering, client registration, packaging, labelling and shipping records.
“Cannabis has been used medicinally pretty much throughout the entire timeline of written history, and from archeological evidence, far beyond into antiquity. Virtually every culture who had access to it either from local flora or trade, which was widespread, used it medicinally and recreationally," …
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Licenced Producer application process for Medical Marijuana:
Applying for a commercial Production License through Health Canada's MMPR program?
We have the experience to provide consulting for the application process. Contact Us for details. We have recently helped a client develop a quality system compliant with the regulations and required under Section 10 and Section 11 of the application to become a licensed producer. Section 10 and Section 11 of the application to become a Licensed Producer under the Marihuana for Medical Purposes Regulations is provided below.
SECTION 10: Quality Assurance Pre-Licensing Report
A licensed producer must have an employee designated as a quality assurance person who is responsible for assuring the quality of the dried marihuana, before it is made available for sale.
This employee must have the training, experience and technical knowledge related to the proposed licensed activities and the requirements of the MMPR.
The applicant must submit a document signed and dated by the quality assurance person that
Section 11. RECORD KEEPING
Please provide in an attachment a detailed description of your proposed record keeping methods. Your
proposed record keeping methods must comply with Part 6 of the MMPR.
We recommend you submit a detailed description of your proposed record-keeping methods and examples of the documents you are planning to use to ensure compliance with the regulations. We have worked with clients and Health Canada and fully understand exactly what is required to exceed the Health Canada requirements for record keeping.