Review process under Canada's Access to Medicines Regime
Countries can be assured that products purchased under Canada's Access to Medicines Regime meet the same health and safety standards as products sold in Canada. Manufacturers are required to submit scientific evidence of a product's safety, effectiveness and quality to Health Canada, Canada's national drug regulatory authority, before receiving permission to export it.
Health Canada will review all products destined for export under the Regime to ensure that they meet the requirements of Canada's Food and Drugs Act and Regulations, and that they include measures designed to prevent the diversion of products to unintended markets. A special review stream has been created for these products to ensure that they are reviewed without undue delay.
A pharmaceutical company filing a new drug submission, an abbreviated new drug submission or medical device application to Health Canada for review should include with its submission a letter of notice indicating that it intends to file or has filed an application for a compulsory licence under Section 21.04 of the Patent Act. This will ensure that the submission is properly routed to the review stream for applications under the Regime. Once the review is complete, Health Canada will inform the company and the Commissioner of Patents by letter whether the product meets the necessary legislative and regulatory requirements.
For further information about the regulation of drugs and medical devices, including how to file a drug submission for a drug eligible for export under the Regime, see Health Canada's Health Products and Food Branch.
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