Expanded Sunscreen Pilot – Health Canada

by | Mar 14, 2019 | Canadian Regulatory, Cosmetics, OTC Drugs, U.S. Regulatory | 0 comments

Having fun in the sun is usually not a good idea without having proper sunscreen protection. Sunscreens are equipped with active ingredients that prevent damage from UV rays by using either chemical or physical UV filters. However, with most sunscreen products in Canada being categorized as drug products due to their sun protection factor (SPF) content, importing them into the country has been a regulatory burden. The Expanded Sunscreen Pilot aims to reduce this burden.

A Health Canada project worked to reduce this burden by decreasing the regulatory requirements for sunscreen products being imported from the U.S. After the one-year pilot project, which ran from February 27th, 2017 to February 27th, 2018, Health Canada is now looking to expand the pilot to include additional jurisdictions, including Mexico, Japan, Australia, Switzerland, the European Community (EC), and the European Economic Area – European Free Trade Association (EEA – EFTA). This project, to expand the Sunscreen Pilot to include other countries with existing Mutual Recognition Agreements (MRAs) will significantly reduce, or eliminate completely, the need for additional confirmatory testing that is done when importing sunscreen products into Canada.

The details of the expansion are outlined in Drug Establishment Licensing (DEL) Bulletin #41, which was issued by Health Canada in November 2018, and will come into effect February 14th, 2019. The Expanded Pilot replaces the 5-year limit on absence of US Food and Drug Administration or Heath Canada inspections with mandating that GMP renewal evidence be submitted on or before a New Evidence Required By (NERBY) date. It also includes sunscreen products which have been fabricated in Canada, but packaged, tested, or labelled in any of the original or newly included jurisdictions. Currently, the project’s focus is on sunscreens, however other low-risk products such as anti-dandruff shampoo and mouthwash may be introduced in the future.

The application process for participating in the Expanded Sunscreen Pilot includes submitting a complete application package, which can be found on the Health Canada website.

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.