There are many questions you may be asking yourself when considering applying for a commercial licence to produce and sell medical marijuana such as:

• How can I optimize the application process to avoid unnecessary delays resulting from errors, deficient content etc.?
• What are the steps taken in obtaining a licence to sell medical marijuana and what type of investment in both time and funding could be expected?
• How can I meet security requirements and what options are available?
• What production systems and equipment are available?
• What does Health Canada look for when conducting inspections?

A PipeDreemz Inc. ACMPR Consultant can assist in providing the support needed to answer any of your questions and expedite the process leading to a commercial licence to produce and sell medical marijuana. The process is highly regulated and many applicants find it difficult to navigate without expert knowledge and support.

Historical Overview of the Legalization of Medical Marijuana

Due to a number of Court decisions, Health Canada has had to create and adapt Federal law to accommodate patients’ use of marijuana for medical purposes.

In the year 2000, an Ontario Court upheld the right of individuals to possess marijuana specifically for medical purposes based on section 7 of the Charter of Rights and Freedoms. The following year (2001) the Federal Government implemented the Marihuana Medical Access Regulations (MMAR) which allowed patients, authorized by their health care practitioner, to obtain marijuana by growing a designated number of plants independently or through a designated grower or through direct purchase of dried marijuana from Health Canada.

Subsequently, in 2013, Health Canada established a new set of rules for the growing, buying and selling of marijuana in Canada entitled the Marihuana for Medical Purposes Regulations (MMPR). The MMPR set out rules for the establishment of a commercial industry for medical marijuana involving doctors, patients and large-scale commercial growers or Licensed Producers (LP’s). Under the MMPR, individuals with a medical need could legally access quality-controlled dried marijuana produced by LP’s under secure and sanitary conditions. Health care practitioners continued to be responsible for authorizing the use of medical marijuana by patients to treat medical conditions.

Due to Court decisions in 2015 and early 2016, the MMPR was replaced by the Access to Cannabis for Medical Purposes Regulations (ACMPR) in August 24, 2016. The ACMPR now allows Licensed Producers to produce and sell alternative forms of cannabis other than dried marijuana including cannabis oil, fresh marijuana buds, seeds and plants as well as allowing authorized users to possess and alter different forms of cannabis.

Overview of ACMPR Changes from the MMPR

Notable changes for LP’s under the ACMPR include new labelling requirements, modification of the accuracy requirements of weight and volume of packaged products, application of analytical testing requirements for all products using validated methods and notification to the Minister of Health prior to commencing a recall. Transitional provisions allowed for those applications submitted under the MMPR to continue to be accepted and processed as well as all licenses and security clearances that had been granted under the MMPR to continue under the ACMPR.

Furthermore, the ACMPR sets out the provisions under which authorized individuals, or their designate, may legally grow a limited number of marijuana plants that would provide the prescribed amount of cannabis (in grams) to treat their medical condition(s) as stipulated in a medical document by the health care practitioner. Were a patient to use a designated grower, that person must provide documentation issued by a Canadian police force of no prior drug offences within the previous 10 years and may only produce marijuana for a maximum of two individuals including themselves. Patients or their designate must provide the location of where the cannabis will be produced (restrictions apply) and stored and, where applicable, requirements for transportation and/or shipping. In addition, there are requirements for the maintenance of any measures necessary to protect the security of the cannabis produced.

The role of health care practitioners has remained unchanged under the ACMPR. Should the practitioner decide that cannabis is a good treatment option for a patient, a medical document must be completed. This document allows patients to obtain cannabis either through a Licensed Producer where strict regulations regarding product quality and composition (e.g. THC, CBD content) are ensured or by producing a limited amount of cannabis for themselves or through a designate as stipulated in the medical documentation.

Advantages of Purchase from Licensed Producers

Although certain patients may opt to grow their own supply of marijuana, purchase from a Licensed Producer provides numerous advantages. Under the ACMPR Licensed Producers are required to adhere to strict quality control conditions that severely reduces the likelihood of adulteration of the marijuana from pests, microorganisms or other contaminants. A variety of strains of marijuana are available with the THC and CBD content determined through analytical testing. As such, patients may choose from a variety of strains of dried marijuana, or alternative forms, that provide optimal therapeutic value. Patients are also provided a continuous supply, as per medical documentation requirements, that is delivered to their doorstep by courier in nondescript packaging. Furthermore, from a safety standpoint, patients do not need to be concerned about potential theft in producing their own supply or of an interruption in their supply due to unforeseen circumstances during production. They are also assured of refund or replacement of any product in the unlikely event there should be a need for product recall.

While becoming a Licensed Producer of Cannabis entails a considerable investment of time and financial commitment, there is the potential for substantial benefit in this new burgeoning commercial industry.  Not only do authorized patients benefit from treatment with medical marijuana, licensed producers prosper as well. As medical marijuana production and sales is highly regulated, the support provided by an experienced PipeDreemz Inc. ACMPR Consultant can facilitate the achievement of a successful business enterprise.

Application Process to become a Licensed Producer of Cannabis for Medical Purposes

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-use-marijuana/licensed-producers/application-process-becoming-licensed-producer.html

1. Application Form

The first step towards becoming a Licensed Producer is completing the Application Form which includes a Security Clearance Application Form and Security Clearance Fingerprint Third Party Consent to Release Personal Information Form.

Completing these forms in a thorough and accurate manner is essential to avoid return and/or delaying the process. PipeDreemz Inc. ACRMP consultants can review an application prior to submission to ensure proper content, qualified personnel and security measures meet requirements the requirements under the ACMPR.

2. Intake and Initial Screening Application Forms

Once an application is received by Health Canada it undergoes a preliminary screening to check for completeness. If the application appears complete, it will be assigned an application number which should be referenced in all correspondence with Health Canada. If an application is not complete, Health Canada may contact the applicant for missing information or the application will be returned.

If a submitted application is incomplete and is returned or results in queries by Health Canada, a PipeDreemz Inc. ACMPR Consultant is available to provide assistance in rectifying any deficiencies in content and/or responding to any concerns raised by Health Canada.

3. Detailed Review and Initiation of Security Clearance Process

An extensive review of the application is then undertaken to ensure compliance with the ACMPR, to establish if any risks to public health, safety or security are evident and to ensure there are no other grounds for refusal. Also considered are the proposed security measures and physical security plans, a description of the cannabis storage area, the credentials of the Quality Assurance person and quality assurance measures relating to the premises, equipment and sanitation program. Security clearance forms for relevant personnel must also be submitted. Applicants must also meet all zoning restrictions, fire and electrical safety and environmental legislation within their province or territory.

At this stage, applicants may experience multiple contacts with Health Canada to provide clarification and/or additional information regarding the application. An experienced PipeDreemz Inc. ACMPR Consultant can provide valuable knowledge and support in responding to such inquiries thereby accelerating the application process.

4. Issuance of License to Produce

Health Canada will provide a licence to produce cannabis once it is confirmed that the application meets all the requirements under the ACMPR and an inspection has taken place.

5. Introductory Inspection

Once a licence to produce cannabis has been authorized, Health Canada must be notified as cultivation begins. At this time, an initial inspection will be scheduled and subsequently conducted to ensure the licensed producer is meeting the requirements of the ACMPR including physical security, record keeping and Good Production Practices (GPP) as well as to confirm the activities being conducted correspond to those indicated on the licence.

A PipeDreemz Inc. ACMPR Consultant can inspect the site and review all required documentation prior to the Health Canada Inspection to avoid delays should any deficiencies be evident.

6. Pre-Sales Inspection:

In order to sell cannabis to authorized patients, a licensed producer must submit an amendment application to the Office of Medical Cannabis. Health Canada will then schedule and conduct a pre-sales inspection to ensure requirements under the ACMPR are being met including GPP, packaging, labelling, shipping and record keeping activities.

A PipeDreemz Inc. ACMPR consultant can inspect sales related activities and review all required documentation including record keeping practices prior to the Health Canada Inspection to avoid delays should any deficiencies be evident.

7. Issuance of License to Sell

Prior to issuing a licence to sell, the amendment application will be reviewed including the results of the pre-sales inspection and any other relevant information. Once the review is completed, an amended licence that includes the activity of sale will be issued.

Considerations

The entire application process may take more than a year to complete such that avoiding delays due to an incomplete application, insufficient or inaccurate information, inadequate security measures, unqualified personnel etc. is critical in moving an application forward.

Whether you are considering applying for a licence, are held up in the application process, or you are experiencing production problems, the experienced ACMPR Consultants at PipeDreemz Inc. can provide solutions that will facilitate the development of a successful business in the Medical Marijuana industry.

Our consultants are available to assist from initial application to site selection, facility design and construction, production planning, laboratory and testing needs, operational systems (e.g. HVAC, Fertigation), recruiting and training qualified personnel as well as security systems. PipeDreemz Inc. Consultants also can conduct pre-inspections to ensure meeting all requirements under the ACMPR.

Contact an ACMPR consultant at PipeDreemz Inc. to discuss your medical marijuana business needs. PipeDreemz Inc. has a team of consultant specialists who are dedicated to guide you throughout the process and provide effective business solutions.