2024-08-14 13:00:00
August 14, 2024
Our file number: 24-106412-576
Health Canada is pleased to announce the release of the final version of the guidance: a change in sales status from “prescription” to “over-the-counter”.
This document replaces the current guidance “Information Requirements for Changes in Drug Ingredients from “Prescription” to “Over-the-counter” and will be effective 60 days after this issuance.
New guide:
Describes a new process for converting prescription drug sales status to natural health products; provides further guidance on information requirements for status changes; introduces a new template to be completed and included with all status change requests.
Health Canada would like to thank everyone who participated in the consultation and submitted comments on the revised draft guidance between April 21 and June 20, 2022. A Health Canada working group that included multiple departments took these comments into consideration when finalizing the document.
You are welcome to send any questions or comments about these guidelines to the following address:
Office of International Policy, Science and Programs
The Goods Administration
health canada
Dutch Cross, Section B
6th Floor, Address Index: 3102C
1600, Scott Street
Ottawa ON K1A 0K9
Email: policy_bureau_enquiries@hc-sc.gc.ca
1723732482
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