Direct to Retailer Importing – Drug Products
Importers familiar with the requirements for testing have long voiced their frustration with obligations to perform confirmatory testing on drugs received in Canada. Because of the broad regulations covering drug products of all risk levels, low risk drugs were required to undergo the same level of testing as high risk prescription drugs, even though many categories of OTC drugs have a long history of safe use in Canada. These testing requirements have delayed the entry to market of low risk drugs because upon receipt in Canada they were required to be held in quarantine at receiving warehouses while confirmatory testing was undertaken, and while awaiting test results to confirm products meet their finished product specifications.
The recent adjustment to the Good Manufacturing Practices (GMP) portion of the regulations, specifically Regulation C.02.019 exempt specific groups of OTC drugs from confirmatory tests, as long as these products have been approved by regulatory authorities in foreign countries outside of Canada. These countries must be members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).
By removing the additional testing requirement for drug products, Health Canada has reduced the delays in getting these products into retailers. Retailers can now receive drugs directly from foreign manufacturing sites, as long as the responsible importer has first received documentation such as batch certificate or certificates of analysis to confirm drugs comply with their specifications. Additionally, importers and distributors of these drugs must have measures in place to ensure GMP requirements are met at their sites and at their foreign supply sites. Health Canada recommends quality technical agreements as a means of identifying roles and responsibilities between all parties including the foreign manufacturer, importer and person receiving the product (e.g. the retailer or wholesaler).
While the current list covers a limited number of product categories (acne products, medicated skin care products, sunscreens) Health Canada is actively working to increase the number of products to which the regulatory amendments apply.
