Guidance for health products containing cannabis or for use with cannabis

Overview

The purpose of this document is to inform stakeholders about the regulatory framework for health products containing cannabis or for use with cannabis that are approved under the Food and Drugs Act. This framework includes requirements for licensed activities, rules that apply to the health products themselves, and obligations for certain healthcare professionals.

In this guide

• 1. Introduction
  • 1.1. Purpose
  • 1.2. Background
  • 1.3. Overview of new legislative framework
  • 1.4. Scope and application
• 2. Health Research and Clinical Trials with cannabis
  • 2.1. Requirements for the authorization of a clinical trial
  • 2.2. Research Licences under the Cannabis Act
• 3. Pre-market evaluation of health products under the FDA
  • 3.1. Context
  • 3.2. Prescription Drug Listing & Impacts
  • 3.3. Prescription Drug Submissions (for human or veterinary use)
  • 3.4. Natural Health Product Applications
  • 3.5. Veterinary Health Products
  • 3.6. Medical Device Licence Application
  • 3.7. Management of enquiries, submissions and applications
• 4. Cannabis Drug Licence
  • 4.1. Context
  • 4.2. Cannabis Drug Licence Requirements
  • 4.3. Authorizations for Sale
• 5. Cannabis Act restrictions and authorizations that apply to health products
  • 5.1. Context
  • 5.2. Prescription drugs (for human or veterinary use)
  • 5.3. Natural Health Products and Veterinary Health Products
  • 5.4. Medical Devices
• 6. Practitioners, Pharmacists and Hospitals
  • 6.1. Context
  • 6.2. Authorizations
  • 6.3. Obligations
  • 6.4. Notices
  • 6.5. Other
• 7. Additional Requirements
  • 7.1. Import & Export
• 8. Annex A: Cannabis Drug Licence Application Details
• 9. Appendix B: Where to request further information

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Details and history

Published:

July 11, 2018

For assistance

For information to support the development of an application for a drug for human use, the Pharmaceutical Drugs Directorate can be reached at pharma_drug_enquiries-renseignements_medicaments_pharma@hc-sc.gc.ca.

For information to support the development of an application for a natural health product, consult Towards a pathway for health products containing cannabidiol, and contact the Natural and Non-prescription Drugs Directorate: nnhpd.consultation-dpsnso@hc-sc.gc.ca

For information to support the development of an application for a medical device, the Medical Devices Directorate can be reached at meddevices-instrumentsmed@hc-sc.gc.ca.

For information about veterinary drugs and veterinary drugs, the Veterinary Drugs Directorate can be reached at: vdd.vetdrugs-medsvet.dmv@hc-sc.gc.ca.

For information about veterinary health products, please contact: vhp-psa@hc-sc.gc.ca

To apply for a Cannabis Drug Licence, please contact Health Canada at: cannabis@hc-sc.gc.ca. The Department will work closely with applicants to outline the requirements and the process for submitting an application.

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