Anti-diversionary Measures
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 Guidance to Industry: Access to Medicines: Application Process for Drugs for Export to
Developing and Least-Developed Countries.
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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