Pilot for Sunscreen Importers

Heath Canada is giving importers of sunscreen products a bit of breathing room when it comes to Good Manufacturing Practices required by the Food & Drug Regulations.

Sunscreens that are regulated as drug products may only be imported by those parties that hold a Drug Establishment Licence (DEL) confirming their compliance with Heath Canada’s Good Manufacturing Practices (GMP). One of the main responsibilities of an importer is to ensure that finished product testing is applied to all drug products sold in Canada. This unique regulatory obligation placed on import facilities often results in additional cost, responsibility and delay while products are put on hold or “quarantined” while awaiting release into inventory by qualified personnel.

Health Canada has selected the sunscreen products for a pilot project involving modified options for testing when the products are imported from the United States, Australia and several European jurisdictions. The pilot project was announced in 2017, and this week Health Canada announced further details on an expanded sunscreen pilot as of February 14, 2019 for those groups still interested in participating.

Importers who would like to participate in the pilot can submit the application forms and required information and once approved, will enjoy the benefit of shipping products directly to retailers without the requirement for quarantine holds at import facilities.

In order to be accepted into the program, importers should hold a valid drug establishment license and must be able to demonstrate GMP compliance of their foreign suppliers. Foreign facilities that manufacture and export sunscreens must be listed in the Foreign Building Annex portion of the importer’s DEL. Providing evidence of GMP compliance for foreign buildings can be challenging at times, especially if the foreign building has not undergone an inspection by Health Canada or a local regulatory authority. Health Canada will accept consultant audits as evidence of GMP compliance for these sites, which is a great opportunity and point of entry for those facilities who have not undergone a formal inspection.

Record keeping is a mandatory component of GMP and the pilot project. Importers should be prepared for record-related document requests by Health Canada at any time. This will allow Health Canada to verify that the pilot program requirements are being met by participants. We can help you establish your record keeping systems and conduct a corporate audit of your foreign supplier, contact us at for more information.