Submit an application under Canada's Access to Medicines Regime

The company must submit the application package to the Commissioner of Patents at the Canadian Intellectual Property Office (CIPO). For contact information, see Contacts.

All correspondence and envelopes for the Commissioner must indicate that they relate to Section 21.04 of the Patent Act and be

• written in English or French;
• addressed to the Commissioner; and
• delivered by hand or by mail.

Note: If the application package is received incomplete, the application will be put on hold until all documents have been submitted.

The application package must include

• an application for authorization;
• a solemn or statutory declaration from the applicant stating that it has attempted to negotiate a voluntary licence;
• a solemn or statutory declaration regarding the identity of the product and its patent status in the importing country; and
• a certified copy of the importing country's notification to the World Trade Organization or the Government of Canada.

A copy of the application to the Commissioner of Patents must be filed with Health Canada. This copy can be sent after the drug or medical device submission is filed for regulatory review with Health Canada, but must be received before Health Canada notifies the Commissioner of Patents that the product meets the requirements of the Food and Drugs Act and its associated Regulations.

Copies of the forms required for the application package are provided on this website. For the most up-to-date versions of the forms, consult the CIPO website for the Regime. If a compulsory licence is issued, the licence holder must ensure that it continues meeting the terms and conditions of a compulsory licence throughout the period of its validity.