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Found 10 records similar to How to comply with procedures under Canada's Access to Medicines Regime

Federal

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.

Last Updated: Sep. 17, 2020
Date Published: Mar. 29, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Canada's Access to Medicines Regime, manufacturing capacity, eligible importing country, insufficient or no pharmaceutical manufacturing capacity.
Federal

Canada's Access to Medicines Regime includes a number of measures to prevent diversion of drugs and medical devices to unintended markets.

Last Updated: Sep. 17, 2020
Date Published: Mar. 29, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Canada's Access to Medicines Regime, Anti-diversionary measures, prevent diversion of drugs and medical devices, unintended markets.
Federal

It presents WTO-Member Countries Eligible to Import Under the Regime

Last Updated: Sep. 17, 2020
Date Published: Mar. 17, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Canada's Access to Medicines Regime, WTO-member countries, countries eligible to import under the Regime.
Federal

It presents the list Least-Developed Countries Eligible to Import Under the Regime.

Last Updated: Sep. 17, 2020
Date Published: Mar. 17, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Canada's Access to Medicines Regime, Least-developed countries, countries eligible to import under the Regime.
Federal

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.

Last Updated: Sep. 17, 2020
Date Published: Mar. 29, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Canada's Access to Medicines Regime, Good faith clause, patent holders, right to challenge, compulsory licence.
Federal

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.

Last Updated: Sep. 17, 2020
Date Published: Apr. 28, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Process map, application under Canada's Access to Medicines Regime, application for a compulsory licence.
Federal

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.

Last Updated: Sep. 17, 2020
Date Published: Mar. 29, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Canada's Access to Medicines Regime, renewal of licence, original compulsory licence, pharmaceutical company.
Federal

This section contains additional information and documentation.

Last Updated: Sep. 17, 2020
Date Published: Mar. 17, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Canada's Access to Medicines Regime, supplementary documents.
Federal

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.

Last Updated: Sep. 17, 2020
Date Published: Mar. 29, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Company requirements under Canada's Access to Medicines Regime, sales agreement, compulsory licence, eligible importing country, eligible product, application for authorization to Canada's Commissioner of Patents.
Federal

The company must submit the application package to the Commissioner of Patents at the Canadian Intellectual Property Office (CIPO).

Last Updated: Sep. 17, 2020
Date Published: Apr. 28, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Canada's Access to Medicines Regime, submit the application package, the Commissioner of Patents at the Canadian Intellectual Property Office.
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