Changes to Exceptional Release Measures for Hand Sanitizers
By: Jacqui Jenskey, Senior Regulatory Affairs Specialist, email
In March 2020, Health Canada introduced an interim measure for the exceptional release of hand sanitizers and hard surface disinfectants to expedite access to products that may not fully meet regulatory requirements under the Food and Drugs Act. This measure included the importation of a product authorized in Canada, but not fully compliant with requirements OR products not authorized in Canada but authorized or registered in the USA, an MRA country or a PIC/S country.
As of January 15, 2021, Health Canada stopped accepting notification forms for hand sanitizers under this interim measure pathway. Health Canada has determined that the supply of hand sanitizers now has sufficient domestic manufacturing capacity to meet demand.
This change does not affect any products already accepted into this interim measure and only applies to new applications. These currently accepted products will continue to be allowed to be imported and/or sold under their current exceptional release measures approvals. For any applications that were made prior to January 15, 2021 but not yet accepted, they will continue to be processed. If your products have been accepted under this measure, Health Canada has indicated they will provide you with advanced notice, outlining the process when the interim measures expire.
The good news is that this notice does not change the exceptional release measures for hard surface disinfectant products. If your hard surface disinfectant is authorized or registered in the USA, an MRA country or a PIC/S country you can continue to apply for approval. If you need assistance completing and submitting the Exceptional Release Measures form for your product, Dell Tech is happy to help. Contact Jacqui Jenskey, Senior Regulatory Affairs Specialist for more information.
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