On April 1, 2014 the Marihuana for Medical Purposes Regulations will come into force providing new opportunities for Licensed Producers.
Marihuana (Cannabis) is included in Schedule II of the Controlled Drugs and Substances Act, and as such any activities related to possession, production, importation/exportation, distribution and trafficking is illegal in Canada. On July 30, 2001 the Marihuana Medical Access Regulations (MMAR) were enacted allowing seriously ill people (residing in Canada) access to marihuana for medical purposes. Under the MMAR patients could obtain an Authorization to Possess (ATP) marihuana and/or a license to produce marihuana for medical purposes. Under the MMAR patients could obtain either marihuana seeds for the purpose of growing their own personal supply or dried marihuana for medical purposes with both being available from Health Canada.
As of March 31, 2014 the Marihuana Medical Access Regulations will be repealed and as such the means for accessing marihuana under the Medical Marihuana Access Program will no longer be available. Between June 19, 2013 (when the Marihuana for Medical Purposes Regulations (MMPR) was published in the Canada Gazette, Part II) and March 31st there will be a transition period. During the transition period patients may obtain marihuana for medical purposes from either Health Canada or from a licensed producer.
On April 1, 2014 the Marihuana for Medical Purposes Regulations (MMPR) will come into force and marihuana for medical purposes may only be obtained from a licensed producer. Under the MMPR only Licensed Producers will be authorized to possess, sell, provide, ship, deliver, transport, destroy, produce, export and/or import marihuana for medical purposes. Additionally, persons who possess and produce cannabis, other than marihuana, solely for the purpose of conducting in vitro testing and sell, provide, ship, deliver, transport and destroy cannabis, other than marihuana, will also need to apply to become a Licensed Producer.
Health Canada has not set any restrictions on the strains that must be used or the price that the marihuana for medical purposes will be sold. It is important to note that Marihuana will not receive a Drug Identification Number (DIN), as it has not been assessed by Health Canada for safety, efficacy and quality, and thus is considered an unapproved therapeutic product. Additionally the MMAR only applies to the possession, production, importation/ exportation, distribution and sale of either marihuana seeds or dried marihuana plants, as such resins or oils would be exempt.
In order to become a Licensed Producer you will be required to be in compliance with the applicable Acts and Regulations including the MMPR. Under the MMPR Licensed Producers will have to be in compliance with Good Production Practices (GPP) and have written SOPs in place for pest control, microbial and chemical contaminants, sanitation, recall, QA and adverse reaction reporting. The MMPR also sets out specific requirements regarding the packaging, labeling and testing of marihuana for medical purposes as well as specific security measures and record keeping practices that must be met. Furthermore, a Licensed Producer’s application must identify a Senior Person in Charge (PIC) and Responsible PIC with Security Clearances submitted for each of these individuals. Once an application for a Licensed Producer has been completed and processed by Health Canada the applicant must undergo an on-site audit to begin operations. Health Canada has set a performance target of 10 weeks to process completed Licensed Producer Applications, amendments and renewals that are fully complete.
Dicentra can assist you with navigating the regulatory landscape to assist you with obtaining your Licensed Producer license, while being in compliance with the Marihuana for Medical Purposes Regulations. We can be reached at 1-866-647-3279 or info@dicentra.com