Renewal of 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.
The company should complete and submit to the Commissioner of Patents an Application for Renewal of Authorization Under Section 21.12 of the Patent Act. The application for renewal must contain the same information as the original application. The company must certify that the quantity of the pharmaceutical product that had been authorized to be made and exported has not been fully exported within the initial two-year term and that the company has met the original terms and conditions of the compulsory licence.
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