Anti-diversionary measures under Canada's Access to Medicines Regime
Canada's Access to Medicines Regime includes a number of measures to prevent diversion of drugs and medical devices to unintended markets. Licensed products must have anti-diversionary features, including specific markings, colouring and labelling, as applicable, to make them distinguishable from the patented versions available on the Canadian market:
The distinguishing features are reviewed by Health Canada during the health and safety review of the product. For more information about anti-diversionary, and health and safety requirements, see the Food and Drugs Act and its associated Regulations and Health Canada's associated guidance documents.
A country that is not a member of the World Trade Organization will be removed from the list of eligible importing countries, if that country fails to adopt anti-diversion measures as specified by Article 4 of the August 2003 decision of the WTO. A licence will be terminated if the licensed product is re-exported from the intended importing country with the knowledge of the license holder and in a manner contrary to the WTO decision of August 2003.
The company must also ensure that all conditions of compulsory licences are met.
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