Guidance for health products containing cannabis or for use with cannabis
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
- 2. Health Research and Clinical Trials with cannabis
- 3. Pre-market evaluation of health products under the FDA
- 4. Cannabis Drug Licence
- 5. Cannabis Act restrictions and authorizations that apply to health products
- 6. Practitioners, Pharmacists and Hospitals
- 7. Additional Requirements
- 8. Annex A: Cannabis Drug Licence Application Details
- 9. Appendix B: Where to request further information
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Details and history
July 11, 2018
For information to support the development of an application for a drug for human use, a natural health product, or a medical device, the cannabis single window can be reached at: firstname.lastname@example.org
For information about veterinary drugs and veterinary drugs, the Veterinary Drugs Directorate can be reached at: email@example.com.
For information about veterinary health products, please contact: hc.VHP-PSA.firstname.lastname@example.org
To apply for a Cannabis Drug Licence, please contact Health Canada at: email@example.com. The Department will work closely with applicants to outline the requirements and the process for submitting an application.
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