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Mandatory - Testing of Medicinal Marijuana

Health Canada is stepping away from being the provider of Medical Marijuana and focusing on their role as the regulatory body. Medical Marijuana being treated much more like a true pharmaceutical in the way that it's going to be controlled and accessed by licensed patients.

In order to achieve purity and quality of the finished dried marihuana product, Good Production Practices as outlined in the MMPR must be followed at all stages of production, packaging, labelling and storage of the marihuana.

As specified in the MMPR, each batch or lot of dried marihuana must be approved for release by the LP's Quality Assurance person, who must have the training, experience and technical knowledge relating to the activity conducted and the requirements of Division 4 of the MMPR. This means that the Quality Assurance person must have the ability to evaluate the operations of the LP to ensure compliance with Division 4, of Health Canada’s guidance document for Technical Specifications for Testing Dried Marihuana for Medical Purposes, and the technical knowledge to be able to assess analytical testing results in order to be able to make the determination of whether the dried marihuana is suitable for sale. The Quality Assurance person is also responsible for investigating quality-related complaints and taking corrective and preventive actions, if necessary.

Visual inspection should confirm the absence of pests or extraneous substances. The microbial and chemical contaminants of dried marihuana must be within generally accepted tolerance limits for herbal medicines for human consumption. LPs must maintain consistent specifications for their products, and assess each lot or batch of dried marihuana against those specifications before approving the release of a lot or batch for sale.

Analytical testing for those contaminants and for the percentages of delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) referred to in these Regulations must be conducted using validated methods.

Testing of dried marihuana can only be performed by the holder of a producer's licence under the MMPR or of a dealer's licence under the Narcotic Control Regulations, and must be performed according to validated methods.

Marihuana must not be treated - before, during or after the drying process - with a pest control product that has not been registered under the Pest Control Products Act for use on marihuana for medical purposes.

Dried marihuana must not contain any residue of a pest control product in excess of any maximum residue.

Analysis for cannabinoid profiles is a very important piece of the Cannabis Quality Assurance for any medical marijuana patient.

Health Canada provides licenses to medical marijuana producers who are inspected and found in compliance with applicable sections of the following Canadian acts and regulations:

  • Food and Drug Act (FDA)
  • Controlled Drugs and Substances Act (CDSA)
  • Food and Drug Regulations (FDR)
  • Natural Health Product Regulations (NHPR)
  • Narcotic Control Regulations (NCR)
  • Marihuana Medical Access Regulations (MMAR) (In effect until March 31, 2014)
  • Marihuana for Medical Purposes (MMPR) (introduced June 19, 2013)

Under MMAR, licensed marijuana producers must also abide by standards set in Good Manufacturing Practices (GMP), ensuring a controlled, procedure-driven cultivation, processing and testing systems. For instance, if a question of safety or potency is raised, a licensed, GMP-compliant grower should be able to fully trace a specific product or dose, and answer concisely to the medical community and patients.