Health Canada and the Public Health Agency of Canada continue to put their best efforts forward with assisting the supply and demand of products for Canadians amidst the battle against the COVID-19 pandemic. Health Canada has expanded their previously released DEL bulletin 76 by releasing DEL Bulletin 77 to further assist with making in demand products Canadians rely on more accessible. In this new bulletin, Health Canada has temporarily relieved confirmatory and identity testing requirements for certain low risk non-prescription drugs.
Products impacted by this (Annex A of the bulletin) will no longer require identity testing after receipt in Canada and will also not be required to undergo confirmatory testing in the interim during this pandemic. Importers, however, will still be responsible for ensuring products meet their required specifications and were manufactured under Good Manufacturing Practices. This will give importers of products impacted by this the opportunity to directly ship from fabricators to retailers, as long as the importers release the product before being shipped via review of the necessary documentation and test results as well as ensuring quality agreements are put in place between the foreign manufacturer, importer, and receiver of product.
It should be noted that this update to current low risk non-prescription drug import regulations does not exempt the responsibility of Canadian Quality Control department to ensure all products comply with Canadian regulations. These updates simply minimize any delays that may occur in the process of importing non-prescription drugs during these troubling times.
For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA