Licensed producers (LPs) are required to meet certain requirements under the Access to Cannabis for Medical Purposes Regulations (ACMPR). For this reason, it is important for them to understand and to be knowledgeable about these requirements.
What is a Licensed Producer?
A Licensed Producer is an individual/company who has a legal license, issued by Health Canada under the Access to Cannabis for Medical Purposes Regulations (ACMPR), to produce quality-controlled cannabis under safe and sanitary conditions. They are authorized to produce and sell dried cannabis, fresh cannabis, seeds, plants, and cannabis oil. As of July 14, 2017, there are 51 licensed producers of cannabis for medical purposes.
Licensed producers are authorized to sell to registered clients who have been authorized by their healthcare practitioner to use cannabis for medical purposes. Products are delivered to clients securely through the mail or by courier. More than 153,000 individuals are registered to purchase cannabis from licensed producers, while more than 4,000 individuals are registered with Health Canada to produce a limited amount of cannabis for their own medical purposes.
Requirements Under the ACMPR
Under the ACMPR, the requirements include physical security measures, good production practices, packaging, labelling and shipping requirements, import and export permit (if applicable), and security clearance.
Physical Security Measures
The ACMPR set out physical security requirements that are necessary to secure sites where licensed producers conduct activities with cannabis. 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 of cannabis, other than marijuana plants, Health Canada’s Directive on Physical Security Requirements for Controlled Substances establishes security requirements for the storage of all controlled substances including cannabis 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 Subdivision C of the ACMPR.
Good Production Practices
Licensed producers are subject to Good Production Practices that are meant to ensure the cleanliness and sanitation 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 fresh and dried marijuana, marijuana plants, seeds, and cannabis oil prior to making it available for sale.
Information on Good Production Practices can mainly be found under Subdivision D of the ACMPR. You can also refer to our article “What are Good Production Practices for Medical Marijuana?”
Packaging, Labelling and Shipping- Consumer Information
The ACMPR sets out requirements for packaging, labelling and shipping. For example, fresh and dried marijuana, cannabis oil, and marijuana seeds and plants must be sold or provided in tamper-evident containers or packages. Fresh and dried marijuana and cannabis oil must be sold or provided in child-resistant containers. Separate labelling requirements apply depending on the product type (i.e. fresh and dried marijuana, cannabis oil, cannabis oil in capsule or similar dosage forms, and marijuana plants and seeds). In addition, all licensed producers are required to attach a client-specific label, similar to a patient-specific prescription drug label, to the container, package or plant.
Under the ACMPR, each shipment sold to a client needs to be accompanied by a copy of the most current version of the Health Canada document entitled “Consumer Information – Cannabis (Marihuana, marijuana)”. This document provides a summary of the known information about the uses and risks of cannabis for medical purposes so that individuals can be informed about their treatment choice.
Information on Packaging, Labelling and Shipping can mainly be found in Subdivision F of the ACMPR.
Import and Export permit
A licensed producer must obtain a permit from the Minister of Health prior to importing or exporting marijuana or cannabis for the purpose of testing cannabinoid content.
Information on Import and Export can be found in Subdivision G of the ACMPR.
The following individuals are required to have a valid security clearance under the ACMPR:
Individuals seeking to obtain security clearance must complete the following forms:
Information on Security Clearances can be found in Subdivision H of the ACMPR.
Licensed Producers are also required to comply to sections of the Food and Drugs Act (FDA) and Narcotic Control Regulations (NCR) that apply to cannabis. Health Canada also conducts inspections and testing of cannabis products produced by licensed producers to ensure that the products are safe and quality-controlled.