OTTAWA, April 21, 2017 /CNW/ - Canadians who use medications to improve or maintain their health and wellbeing rely on Health Canada to continue to monitor the safety of drugs it has authorized for use in Canada, and to take prompt action if new risks are identified.
Under these proposed regulations, Health Canada would be able to require companies to conduct new tests or studies, or to compile new information and report back to the Department.
Companies will also be required to notify Health Canada of any actions requested or required by a regulator in another jurisdiction such as risk communications, label changes, recalls, or licence suspensions. Failure to comply could result in companies being subject to increased fines and penalties which have already come into force under Vanessa's Law.
These changes will lead to improved patient safety and better health outcomes for Canadians.