The Canada Gazette posting is related to therapeutic products – which includes drugs and medical devices, the latter of which are not in-scope for Cosmetics Alliance.
We are highlighting some key points that may be of relevance to our members:
- Amending the F&DR to address deficiencies in the current regulations with respect to recalls. The changes to the recall regulations reflect current practices found in guidance for voluntary recalls. The changes in these regulations will also incorporate a sufficient framework for recalls ordered by the government.
- Amending the regulations concerning Drug Establishment Licensing to incorporate by reference, a listing of Health Canada mutual recognition agreement (MRA) partners.
- Modifications to finished product testing regulations under the GMPs to exempt a packager, labeller, importer or distributor from performing finished product testing for certain drugs that cannot practically or reasonable be subjected to finished product testing and allow direct shipping to a person other than an importer (i.e. a health care provider) for radiopharmaceuticals, radionuclide generators, gene therapy products and cell therapy products.
- The consultation length is 75 days and will end on June 29, 2023.
We will continue to analyze and will discuss with our PCMA and FCM committees if there is a need to engage in the F&DR portions of this posting.
