Notice - Release of the final guidance document: “Switching from prescription to non-prescription status”

August 14, 2024
Our file number:  24-106412-576

Health Canada is pleased to announce the release of the final version of the guidance document: “Switching from prescription to non-prescription status”.

This document replaces the guidance document “Data requirements for switching medicinal ingredients from prescription to non-prescription status” and comes into effect 60 days after its posting.

This new version of the guidance document

• outlines a new process for prescription to natural health product switches;
• provides more in-depth guidance on data requirements for switches; and
• introduces a new template to be included in all switch submissions.

Health Canada thanks all those who provided comments on the draft revised guidance document during the external consultation held from April 21 to June 20, 2022. Health Canada’s multi-directorate working group finalized the guidance document taking into consideration the feedback received from the consultation.

Questions or concerns about this guidance document should be directed to:

Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
6th Floor, Address Locator 3102C
Ottawa ON  K1A 0K9
E-mail: policy_bureau_enquiries@hc-sc.gc.ca