Notice: Release of the draft revised Guidance Document: Switching a medicinal ingredient from prescription to non-prescription status

April 21, 2022
Our file number: 22-101378-22

Health Canada is pleased to announce the release of the draft revised “Guidance Document: Switching a medicinal ingredient from prescription to non-prescription status” for the purpose of a 60-day public consultation.

Changes to the existing guidance document

Health Canada revised the existing guidance document “Data requirements for switching medicinal ingredients from prescription to non-prescription status” with three objectives in mind:

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

In this guidance document, Health Canada has expanded advice on the data that companies should submit in support of a switch. Also, in support of high quality of submissions, Health Canada is asking all companies requesting switches to complete a new template relative to the Prescription Principles and Factors, and to include it in their switch submission.

Submitting your comments

Please submit your comments to Health Canada by email to policy_bureau_enquiries@hc-sc.gc.ca by June 20, 2022.

After the consultation

By improving the guidance document, Health Canada hopes to assist industry stakeholders in producing high quality submissions that would have greater chances of success.

Health Canada has established a multi-directorate working group that will review all feedback received during this consultation to improve and finalize the document. The final version will replace the current guidance document “Data requirements for switching medicinal ingredients from prescription to non-prescription status”.

It is anticipated that 60 days after the publication of the final version, the new process for prescription to natural health product switches and the final version of the guidance document will come into effect.

Contact

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C5
Ottawa ON  K1A 0K9
E-mail: policy_bureau_enquiries@hc-sc.gc.ca