Company requirements under Canada's Access to Medicines Regime
Drugs and medical devices required to address public health problems, especially those resulting from HIV/AIDS, tuberculosis, malaria and other diseases, are eligible for export under Canada's Access to Medicines Regime. A list of these products is found in Schedule 1 to the Patent Act. Countries can request that the Government of Canada add a drug or medical device to the list. Pharmaceutical companies wanting to export pharmaceutical products that are not protected by patent are not required to use the Regime and can do so under Subsection 37(1) of the Food and Drug Act, which exempts drugs and medical devices from the Act and its associated Regulations, provided that they are manufactured for export only, marked as such and certified not to contravene the requirements of the importing country.
To participate in the Regime, a pharmaceutical company must enter into a sales agreement with an eligible importing country for the purchase of a specified amount of an eligible product listed on Schedule 1. There are three classifications of eligible importing countries, depending on whether a country appears on Schedule 2, Schedule 3 or Schedule 4 to the Patent Act. The Government of Canada may add countries to these schedules.
A pharmaceutical company must also submit an application for authorization to Canada's Commissioner of Patents. Once the authorization or compulsory licence is issued, there are additional terms and conditions that the company must meet and maintain. These include satisfying the requirement for anti-diversionary measures.
Products exported under the Regime must meet the same requirements for safety, efficacy and quality as those intended for Canadians. For more information about the regulatory requirements for drugs and medical devices, including assistance on how to file a submission for a product eligible for export under the Regime, see Health Canada's Health Products and Food Branch.
For information on participating in Canada's Access to Medicines Regime, proceed to Application Process.
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