Additional Information for Licensed Producers under the Access to Cannabis for Medical Purposes Regulations
Licensed producers are required to meet the requirements of the Access to Cannabis for Medical Purposes Regulations (ACMPR) including, but not limited to:
The following information is to help licensed producers understand their requirements under the ACMPR. It is the responsibility of the licensed producer to understand the ACMPR and to be knowledgeable about their obligations.
Licensed producers must also consult the relevant sections of the Food and Drugs Act (FDA) and Narcotic Control Regulations (NCR) that apply to cannabis. Please refer to the ACMPR for more information.
Physical Security Measures
Production, packaging, labelling and storage activities under the ACMPR need to be conducted indoors, and not in a dwelling place.
The ACMPR set out physical security requirements that are necessary to secure sites where licensed producers conduct activities with cannabis other than storage. 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, among other things, to ensure the cleanliness 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 and seeds, and cannabis oil prior to making it available for sale.
Licensed producers must conduct tests on their products, including, as applicable:
- for microbial and chemical contaminants of fresh and dried marijuana, and cannabis oil
- for disintegration of capsules or similar dosage forms of cannabis oil
- for residues of solvents in cannabis oil for content of delta-9-tetrahydrocannabinol, delta-9-tetrahydrocannabinolic acid, cannabidiol and cannabidiolic acid
The Technical Specifications for Testing Dried Marihuana for Medical Purposes guidance document provides specific information for licensed producers to help them meet some of these requirements.
Licensed producers must also meet other requirements under Good Production Practices under the ACMPR including, but not limited to:
- Sanitation Program
- Standard Operating Procedures
- Establishment of a Recall System
Information on Good Production Practices can mainly be found under Subdivision D of the ACMPR.
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 mainly be found in Subdivision G of the ACMPR.
The following individuals are required to have a valid security clearance under the ACMPR:
- the individual who holds a producer's licence
- all officers and directors of a corporation (if the producer's licence is issued to a corporation)
- the Senior Person in Charge
- the Responsible Person in Charge
- the Alternate Person(s) in Charge
Individuals seeking to obtain security clearance must complete the following forms:
- the Security Clearance Application form
- the Security Clearance Fingerprint Third Party Consent to Release Personal Information form (this form will allow a Canadian police force or a fingerprinting company accredited by the RCMP to submit fingerprints to the RCMP for the purposes of a criminal record check)
Information on Security Clearances can mainly be found in Subdivision H of the ACMPR.
If you have any questions regarding these requirements, please contact Health Canada toll-free at 1-866-337-7705 or by email at ACMPR-RACFM@hc-sc.gc.ca.
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