As we reported, the Government of Canada recently published draft regulations under Vanessa’s Law that set out additional reporting requirements for manufacturers, based on the actions of foreign regulators, and provide details regarding the Minister of Health’s powers to require tests, assessments and studies of a post-market drug authorization.
Health Canada has now published two draft guidance documents outlining how the proposed regulations will be implemented.
- The “Draft Guidance Document for Notifying Health Canada of Foreign Risk” provides information relating to the new proposed regulatory requirement to notify Health Canada of foreign risk communications, label changes and recalls.
- Health Canada has also provided drafts of new sections to be added to Health Canada’s guidance document “Guide to New Authorities” that address the Minister of Health’s powers under Vanessa’s Law.
Health Canada is seeking feedback from all interested Canadians on both documents. The consultation is open until September 10, 2017.