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Catalogue Entry: Declare identity and patent status of pharmaceutical product under Canada's...
The pharmaceutical company must complete and submit to the Commissioner of Patents one of the forms listed below. The company should choose the form that corresponds to the...-
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Catalogue Entry: Declaring an attempt at negotiating a voluntary licence under Canada's...
The pharmaceutical company must complete and submit to the Commissioner of Patents a Solemn or Statutory Declaration Under Paragraph 21.04(3)(c) of the Patent Act. The form sets...-
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Catalogue Entry: Declaring monetary value and units sold under Canada's Access to Medicines Regime
Within 15 days of the day on which the compulsory licence was granted or the supply agreement was signed, whichever is later, the pharmaceutical company must complete and submit...-
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Catalogue Entry: 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...-
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Catalogue Entry: Good faith clause under Canada's Access to Medicines 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...-
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Catalogue Entry: Termination of authorization under Canada's Access to Medicines Regime
The patent holder may seek an order from the Federal Court of Canada to terminate a compulsory licence, if the patent holder can establish that any information in the...-
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Catalogue Entry: How to comply with procedures under Canada's Access to Medicines Regime
Instructions for complying with the Requirements of Canada's Access to Medicines Regime specify how to notify the World Trade Organization or the Government of Canada, and how...-
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Catalogue Entry: Role of Non-Governmental Organizations in Canada's Access to Medicines Regime
The Government of Canada regards non-governmental organizations (NGOs) as valuable resources and actively consulted with them when designing Canada's Access to Medicines Regime.-
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Catalogue Entry: Anti-diversionary measures under Canada's Access to Medicines Regime
Canada's Access to Medicines Regime includes a number of measures to prevent diversion of drugs and medical devices to unintended markets.-
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Catalogue Entry: Capacity to manufacture 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...-
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Catalogue Entry: Least-developed countries eligible to import under Canada's Access to...
It presents the list Least-Developed Countries Eligible to Import Under the Regime.-
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Catalogue Entry: WTO-member countries and non-WTO member countries eligible to import under...
It presents WTO-Member Countries and Non-WTO Member Countries Eligible to Import Under the Regime.-
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Catalogue Entry: Features of Canada's Access to Medicines Regime
Below are some of the unique features of Canada's Access to Medicines Regime, many of which resulted from negotiations between the Government of Canada, the private sector and...-
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Catalogue Entry: Regulatory Initiative: Amendments to the Food and Drug Regulations -...
These amendments would introduce a regulatory framework for Drug Shortages within the Food and Drug Regulations.-
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Catalogue Entry: Improving the regulatory review of drugs and devices: Notice to industry -...
The Health Canada and Health Technology Assessment (HTA) review processes are independent of each other. Aligned reviews project will make sure that the timing of Health Canada...-
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Catalogue Entry: Improving the regulatory review of drugs and devices: Early scientific...
This project will result in Health Canada and Health Technology Assessment (HTA) organizations working together. This will allow them to give scientific advice to manufacturers...-
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Catalogue Entry: Improving the regulatory review of drugs and devices: Expanding priority...
This project will build new review pathways for those drugs shown to meet health care system needs. The outcome for the people of Canada will be faster access to drugs,...-
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Catalogue Entry: Improving the regulatory review of drugs and devices: Improving access to...
The updated regulations will help drug makers understand what information should be included in their drug submissions. This will help with product approval and availability.-
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Catalogue Entry: Improving the regulatory review of drugs and devices: Drugs - Special Access...
The Special Access Programme (SAP) provides access to nonmarketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional...-
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Catalogue Entry: Guidance Document: Administrative Processing of Submissions and Applications...
For the purpose of this guidance document, Health Canada has determined that certain submissions and applications involving human or disinfectants drugs may be submitted for...-
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