The new ACMPR merged the MMAR and MMPR regulations to give patients three options to access medical marihuana in response to the Federal Court of Canada's February 2016 decision regarding the Allard v. Canada case. As under the MMPR, the ACMPR allow patients to purchase medical marihuana, (dried, fresh marijuana or cannabis oil) from licensed producers; however, under the new ACMPR, patients have gained two additional means to access cannabis. Personal and designated production were re-introduced by the regulations. As such, individuals can register with Health Canada to be able to produce a limited amount of cannabis for themselves or designate someone else to produce it for them. (Indoors, every 1g per day of medical dried marihuana authorized permits production of five plants. Outdoors, every 1g per day authorized permits the production of two plants).
With the introduction of the ACMPR, a couple of things also changed for licenced producers. The regulations, for instance, introduce new labelling requirements. The product labels must now include the percent of THC and CBD for dried and fresh marihuana (already required for oils), taking into the account the potential to convert THC-Acid and CBD-Acid. Many LPs already provided this information for dried marihuana even though it was not required by the MMPR regulations. In addition, information on the carrier oil for cannabis oils must now be included on the label. For instance, cannabis oil in capsule form must now be labelled with the number of capsules in the container, the net weight, and volume of each capsule. These updates will provide important information to the consumer to enable them to make more informed decisions on what product will best fit their needs.
On the testing side, the ACMPR require that analytical testing (contaminants, disintegration, solvent residues, THC, CBD) is to be done using validated methods. This means that testing methods have to be evaluated for their accuracy, specificity, ruggedness, precision, repeatability, robustness, and linearity before being used to analyze medical marihuana. The validation process is generally used to confirm that an analytical method provides reliable, consistent and generally high quality results. It is a very important part of good analytical practice and a general requirement for all pharmaceutical drug testing. As one of the foremost medical marihuana testing laboratories in Canada, Eurofins Experchem Laboratories Inc. welcomes the change in the regulations as we always stress the importance of high quality and reliable results. Based on the regulations, it is also required that all cannabis made available for sale is tested for microbial and chemical contaminants to ensure they are below generally accepted tolerance limits for human consumption. In addition, cannabis oil must not contain residues of solvents other than those specified in the regulations, and under acceptable limits. Also, all individuals growing cannabis under the ACMPR now have the option to test their products by an accredited laboratory, including patients growing for themselves or designated growers — an option, which was not available under the MMPR.
Generally, licensed producers remain subject to good production practice standards (GPPs) requiring cleanliness of the premises and equipment. Licensed producers also have to employ a quality assurance person with appropriate training and experience to approve the quality of dried marihuana, cannabis oil, plants, or seeds, prior to sale.
Health Canada notes that they have put appropriate infrastructure and human resources in place to enable immediate implementation of the ACMPR, which will allow the receipt of registration applications from the date on which the ACMPR come into force. Health Canada assures that licensed producer applications submitted under the former MMPR will retain their place in the review process and will be processed under the ACMPR. Further, applicants for production licences will be offered the opportunity to update their applications to add new activities with substances other than dried marihuana. Licensing and inspections of commercial producers will continue as under the former MMPR; however, applicants for a producer licence who planned to submit their application shortly did not receive any advanced notice or grace period, so they will have to revamp their application to fit the new regulations.
The ACMPR provide more diverse options to access cannabis for medical purposes; however, storefronts selling marijuana, such as dispensaries and compassion clubs, remain illegal and can’t be supplied by legal sources such as licensed producers. Their products remain unregulated and may not be safe.
- Elfi Daniel-Ivad, Head of Submissions at Experchem Laboratories Inc.
Mrs. Daniel-Ivad received a B.Sc. in Technical Chemistry and an M.Sc. in Biotechnology and Nutrition from the Technical University of Graz, Austria. She received a Postgraduate Regulatory Affairs Diploma (PRA) from the Academy of Applied Pharmaceutical Sciences Inc. (AAPS), in Toronto. Mrs. Daniel-Ivad has been working on regulatory submissions for drugs, natural health products (NHPs), medical devices, and medical marihuana producer licences for the last 10 years as a Regulatory Affairs Manager. Mrs. Daniel-Ivad has an excellent track record of getting applications approved. Experchem Laboratories Inc. is currently working with more than 100 medical marihuana producer licence applicants, which are at different stages of review and approval.