Drug Importation & COVID-19
Health Canada has one of the most rigorous systems in place for importing drug products from outside of Canada. The governing regulations known as the Food & Drug Regulations set out the requirements and standards that must be met by importers and their foreign sites in order to confirm that foreign supply sites operate in compliance with Good Manufacturing Practices (GMP). One of the major hurdles to importing drugs to Canada is the requirements around testing of products before they are released to the Canadian market. Health Canada on March 23rd announced some adjustments to these requirements in order to ensure Canadians have continued access to the medication they rely upon.
Interim approaches are now in place to reduce testing-related delays for drugs imported from non-MRA countries. These measures however will still allow Health Canada to maintain appropriate product quality oversight. Importers of drugs licensed under Division 1A of the Food and Drug Regulations may apply expanded use of unique identifiers to allow for confirmation of identity based on physical verification when the required laboratory testing is not readily available. Importing companies may apply a modified approach to the current unique identifier principles to confirm identity of imported drug products.
Additionally, Health Canada will allow products to be shipped to Canada prior to the completion of all testing and fabricator release (i.e. ship in quarantine). Canadian would still be expected to have appropriate systems to quarantine the incoming shipments until release.
Health Canada will accept deferment of confirmatory testing requirements if companies are not able to conduct such tests. All organizations should ensure that the Canadian quality control department has the responsibility to all product complies with Canadian regulations and marketing authorizations to minimize risks to Canadians.
