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Marihuana for Medical Purposes Regulations (MMPR) Consulting

Opportunity: Licenced Commercial Production, Distribution and Sales - Marihuana

The Marihuana for Medical Purposes Regulations (MMPR) treat dried marihuana as much as possible like a medication by creating a licensing scheme for the commercial production, distribution and sales of dried marihuana for medical purposes in Canada.

Licensed Producers

Canadian Licensed Producers (LP) are permitted to produce marihuana indoors and are able to produce, distribute and sell any strain(s) of marihuana.

In order to be licensed by Health Canada, licensed producers have to demonstrate compliance with requirements related to product quality, personnel, record-keeping, safety and security, disposal and reporting, as set out in the new regulations. These controls ensure the quality of the product being purchased by program participants, as well as the security of production sites.

Licensed producers are subject to regulatory requirements related to security; good production practices; packaging, labelling and shipping; record keeping and reporting; and distribution. They are also subject to Health Canada inspections.

The major benefits of the MMPR include reduction in safety and security risks posed by marihuana cultivation in homes, reduction in program administrative costs, and benefit to producers due to a higher market price and a reduction in economic inefficiency from the removal of current government subsidies on marihuana sold by Health Canada.

In effect, the regulations have created a brand new industry in Canada.

How do I apply to become a licensed producer under the new MMPR?

All applicants for a producer's licence have to comply with the regulatory requirements of the Marihuana for Medical Purposes Regulations.

Commercial Marijuana Production

In this regard, Health Canada has identified compliance with requirements relating to the many aspects of production and distribution as being key to obtaining a commercial producer licence.

Quality Assurance and Testing - Marihuana for Medical Purposes Regulations (MMPR)

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 Licensed Producer, 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 relate 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.

Record Keeping - Marihuana for Medical Purposes Regulations (MMPR)

The Licensed Producer applicant must submit a detailed description of their proposed record keeping methods. This must include a description of the process that will be used for recording transactions relating to all licensed activities, including maintaining appropriate records of transactions and dealings with both suppliers and clients.

The method of record keeping proposed by the applicant must permit compliance with the requirements of Part 6 of the MMPR. The record keeping must allow for the reconciliation of orders for cannabis (including marihuana) and shipments and inventories of cannabis (including marihuana).

Note: The Minister of Health can request that a licensed producer provide records, documents and information referred to in the MMPR in the form and at the time specified by the Minister.

If you require assistance for the MMPR application process, we can help.

Security - Marihuana for Medical Purposes Regulations (MMPR)

The safeguarding of controlled substances is an issue that confronts all manufacturers, distributors, practitioners, pharmacists, law enforcement and government. Health Canada limits the handling of these substances through policies, guidelines and legislation such as the CDSA, the Narcotic Control Regulations (NCR) and the MMPR.

Cannabis, its preparations, derivatives, and similar synthetic preparations as listed under Schedule II of the CDSA are included in the definition of a controlled substance. Those wishing to engage in lawful activities must, therefore, be properly licensed and ensure that the controlled substances are adequately secured and safeguarded at all times for public safety and to minimize risks of diversion.

As part of the application to become a Licensed Producer, you must provide a detailed description of the security measures at the proposed site, in accordance with Division 3 of the MMPR and the Security Directive, published by Health Canada, as amended from time to time. It is up to you to determine potential security risks at your site and to design and implement appropriate security systems and protocols to meet the regulatory requirements outlined above.

Health Canada officials will review your security proposal as part of their consideration of your application. It is important that you seek appropriate professional advice before undertaking any construction work.

The security of your site and of the areas within your site where cannabis is present does not end with the design and construction. Security requirements detailed in the regulations require your attention on a continual basis. It is the ongoing responsibility of the LP to ensure that all requirements for securing their site, areas within their site where cannabis is present and the storage of cannabis and any activities relating to the production of marihuana for medical purposes (as per their licence) are met.

In addition, it is the responsibility of the LP to ensure that provincial, municipal and federal legislation including building, fire codes and zoning are complied with.

If you require assistance for the MMPR application process, we can help. Contact us here.

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