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:
- There must be a permanent display of "XCL" on labels and all solid dosage form products;
- For solid dosage forms, the colour must be significantly different from the version sold in Canada; and
- There must be an export tracking number and the statement, "For export under the General Council Decision. Not for sale in Canada." or "Pour exportation aux termes de la décision du Conseil général. Vente interdite au Canada." on all labels, samples of which must be provided to the Minister of Health.
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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