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Within 15 days of the day on which the compulsory licence was granted or the supply agreement was signed, whichever …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Canada's Access to Medicines Regime declaring monetary value and units sold compulsory licence supply agreement

The pharmaceutical company must complete and submit to the Commissioner of Patents a Solemn or Statutory Declaration Under Paragraph 21.04(3)(c) …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Canada's Access to Medicines Regime declaring an attempt at negotiating a voluntary licence pharmaceutical company submit declaration Commissioner of Patents

The pharmaceutical company must complete and submit to the Commissioner of Patents one of the forms listed below. The company …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Canada's Access to Medicines Regime declare identity and patent status of pharmaceutical product pharmaceutical company Commissioner of Patents.

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

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: 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.

A pharmaceutical company that holds a compulsory licence under Canada's Access to Medicines Regime is required to pay royalties to …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Canada's Access to Medicines Regime company that holds a compulsory licence patent holder Royalty payments.

This process map provides a visual overview of the steps that need to be followed by a pharmaceutical company to …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Process map an application under Canada's Access to Medicines Regime terms and conditions of a compulsory licence.

This process map provides a visual overview of the steps that need to be followed by a pharmaceutical company that …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Process map application under Canada's Access to Medicines Regime application for a compulsory licence.

To participate in the Regime, a pharmaceutical company must enter into a sales agreement with an eligible importing country for …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: 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.

This section contains additional information and documentation.

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Canada's Access to Medicines Regime supplementary documents.

In August 2003, negotiations among World Trade Organization (WTO) members resulted in a landmark decision to waive two licensing provisions …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Canada's Access to Medicines Regime World Trade Organization waive licensing provisions WTO Agreement Intellectual Property Rights developing and least-developed countries import high-quality drugs and medical devices