After significant engagement with CA, Health Canada’s Regulatory Operations and Regions Branch (RORB) has now addressed many of the issues identified by CA and our member companies following their initial announcement of the pilot’s expansion.
As outlined in their Janvier 22nd DEL Bulletin #47, Health Canada’s expanded Sunscreen Pilot includes:
- Expansion of foreign jurisdictions to include: Mexico, Japan, Australia, Switzerland, the European Community (EC) and the European Economic Area – European Free Trade Association (EEA-EFTA)
- Use of Regulatory Authority inspection reports outside their own jurisdictions, with conditions
- Use of corporate/consultant audit reports, with conditions
- Expansion to identity and confirmatory testing
- Expansion to include sunscreen products which are fabricated in Canada but may be packaged, labelled or tested in any of the jurisdictions included in the original or expanded jurisdictions
- Removal of the 5-year limitation on absence of US FDA or HC inspections and replacement with NERBy (New Evidence Required by Date)
These changes will become effective Février 14th, 2019 and will allow participating companies to take full advantage of the pilot with signifiant savings in time, effort and costs. With this expansion now in place, CA will again take up our efforts for a further expansion to include all Category IV and oral care products.
The pilot was intended to provide some interim relief from inappropriate and unnecessary “drug” regulation for these types of low-risk drug (DIN) products as the larger classification issues are being addressed through the Self-Care Framework reform process.
