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Additional information for Licensed Producers under the Marihuana for Medical Purposes Regulations

Licensed producers will be required to meet all the requirements of the Next link will take you to another Web site Marihuana for Medical Purposes Regulations (MMPR) including, but not limited to:

The following are guidance documents to help licensed producers understand the requirements under the MMPR. It is the responsibility of the licensed producer to understand the MMPR and to be knowledgeable about their obligations.

Licensed producers must also consult the relevant sections of the Next link will take you to another Web site Food and Drugs Act (FDA) and Next link will take you to another Web site Narcotic Control Regulations (NCR) that apply to marihuana. Please refer to the MMPR for more information.

Physical Security Measures

Production sites need to be located indoors, and not in a private dwelling.

The MMPR set out physical security requirements that are necessary to secure sites where licensed producers conduct activities with marihuana other than storage. The Guidance Document: Building and Production Security Requirements for Marihuana for Medical Purposes provides technical details on how to meet these security requirements.

For storage, Health Canada's Directive on Physical Security Requirements for Controlled Substances establishes security requirements for the storage of all controlled substances including dried marihuana by licensed producers.

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

Information on Security Measures can be found under Division 3 of the MMPR.

Good Production Practices

Licensed producers are subject to Good Production Practices that are meant, among other things, to ensure the cleanliness of the premises and equipment. The licensed producer is 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.

Product Quality

One of the requirements under Good Production Practices is that licensed producers must test dried marihuana for microbial and chemical contaminants. The Technical Specifications for Testing Dried Marihuana for Medical Purposes guidance document provides specific information for licensed producers to help them meet these requirements.

Other requirements

Licensed producers must also meet other requirements under Good Production Practices under the Marihuana for Medical Purposes Regulations including, but not limited to:

  • Sanitation Program
  • Standard Operating Procedures
  • Establishment of a Recall System

Information on Good Production Practices can be found under Division 4 of the MMPR.

Packaging, Labelling and Shipping- Consumer Information

Dried marihuana must be packaged in a tamper-evident and child-resistant container, and contain standard information about the product (including but not limited to, the weight in grams and the packaging date). In addition, all licensed producers are required to attach a client-specific label, similar to a patient-specific prescription drug label, to the package of dried marihuana.

Under the MMPR, each package of dried marihuana sold to a client needs 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 provides a summary of the known information about the uses and risks of marihuana for medical purposes so that individuals can be informed about their treatment choice.

Information on Packaging, Labelling and Shipping can be found in Division 5 of the MMPR.

Import and Export permit

A licensed producer must obtain a permit from the Minister of Health prior to importing or exporting marihuana. Information on Import and Export can be found in Division 6 of the MMPR.

Security Clearance

The following individuals are required to have a valid security clearance under the Marihuana for Medical Purposes Regulations:

  • the applicant (if an individual)
  • all officers and directors of a corporate applicant
  • the proposed Senior Person in Charge
  • the proposed Responsible Person in Charge
  • the proposed Alternate Person(s) in Charge

Information on Security Clearances can be found in Division 7 of the MMPR.

The Security Clearance Application form and the Security Clearance Fingerprint Third Party Consent to Release Personal Information form (that will allow a Canadian police force or a fingerprinting company accredited by the RCMP to submit fingerprints to the RCMP for the purposes of a criminal record check) are available under the Applying to Become a Licensed Producer under the Marihuana for Medical Purposes Regulations web page.

If you have any questions regarding these requirements, please contact Health Canada toll-free at 1-866-337-7705 or by email at MMPR-RMFM@hc-sc.gc.ca.