Last fall, Health Canada proposed a new framework for regulating “self-care products,” including non-prescription/over-the-counter drugs (“OTCs”), natural health products and cosmetics. The proposal underwent its first round of public consultation in October and is currently being refined. Until it takes effect, a number of products will remain in regulatory limbo.
Fortunately, Health Canada has introduced an interim, testing/quarantine pilot program for OTC sunscreens (the “Pilot”). Under the Pilot, U.S. manufacturers will have the option to ship OTC sunscreen products directly to Canadian retailers, subject to certain restrictions. At present, these products require quarantine and re-testing upon importation into Canada to ensure compliance with Good Manufacturing Practices (“GMP”s), as set out in Part C, Division 2 of the Food and Drug Regulations. The Pilot commenced on February 27, 2017 and will run for one year until February 27, 2018.
To participate in the Pilot, the Canadian importer must hold a valid Drug Establishment Licence (“DEL”), authorized by Health Canada, for the OTC product(s) being imported. Participation is voluntary, so the Canadian importer must register for the Pilot by submitting a Sunscreen Pilot Application Form, a Sunscreen Pilot Table and Direct Shipment tab information, if applicable, to Health Canada. Copies of evidence or documentation may be requested by Health Canada at any time during the Pilot and must be made available within 48 hours.
Some other requirements are, as follows:
- The U.S. manufacturer must already be listed on the Foreign Building Annex to the Canadian importer’s DEL and must continue to be compliant with GMPs.
- At its premises, the Canadian importer must retain evidence that the U.S. manufacturer is compliant with GMPs and has been inspected within the last 5 years by the U.S. Food and Drug Administration or Health Canada. This evidence must be valid for the duration of the Pilot.
- The Canadian importer’s quality assurance person must review the Certificate of Analysis of each lot of products, prior to their release in the Canadian market. At any time, Health Canada may request evidence of this review. It is the Canadian importer’s responsibility to ensure that each lot of products had been fabricated, packaged/labelled, tested and stored in accordance with the requirements of the master production documents.
- The Canadian importer must attest that it has completed a verification of the U.S. manufacturer in the last 2 years to ensure compliance with GMPs and quality agreements.
- If a direct shipment is considered, a system must be in place between the Canadian importer and the retailers to ensure that the right product was received, and that the product’s quality was not compromised throughout its inspection, storage or transportation.
The target timeline for screening and responding to an application to participate in the Pilot is 10 business days. If the application is accepted, the Canadian importer will receive a notification letter listing the eligible OTC products by their Drug Identification Number(s).
For more information on the Pilot or registration process, please contact us.