Canada's Drug and Medical Devices Review Process
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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