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Found 10 records similar to How to comply with procedures under Canada's Access to Medicines Regime
To participate in the Regime, an eligible importing country must declare that it has insufficient or no pharmaceutical manufacturing capacity in relation to the specific product it is requesting. It is up to each country to determine for itself the level of its manufacturing capacity.
Canada's Access to Medicines Regime includes a number of measures to prevent diversion of drugs and medical devices to unintended markets.
It presents WTO-Member Countries Eligible to Import Under the Regime
It presents the list Least-Developed Countries Eligible to Import Under the Regime.
The legislation establishing Canada's Access to Medicines Regime contains a "Good Faith Clause" that provides patent holders with the right to challenge a compulsory licence in the Federal Court of Canada. A challenge can be mounted if the patent holder believes the licence is being used for predominantly commercial rather than humanitarian purposes.
This process map provides a visual overview of the steps that need to be followed by a pharmaceutical company that is preparing to submit an application for a compulsory licence under Canada's Access to Medicines Regime.
Within 30 days of the end of the two-year period of the original compulsory licence, a pharmaceutical company may apply to have it renewed. A renewal will only be granted if the full shipment of the original authorization has not yet been shipped. Only one renewal is allowed for each original application for a total of four years for each compulsory licence.
This section contains additional information and documentation.
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. 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.
The company must submit the application package to the Commissioner of Patents at the Canadian Intellectual Property Office (CIPO).