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About this information

Open data is defined as structured data that is machine-readable, freely shared, used and built on without restrictions.

The key things to remember about open data are:

  • #Availability and access#: the data must be available as a whole and at no more than a reasonable reproduction cost, preferably by downloading over the internet. The data must also be available in a convenient and modifiable form.
  • #Re-use and redistribution#: the data must be provided under terms that permit re-use and redistribution including the intermixing with other datasets.
  • #Universal participation#: everyone must be able to use, re-use and redistribute. There should be no discrimination against fields of endeavour or against persons or groups. For example, 'non-commercial' restrictions that would prevent 'commercial' use, or restrictions of use for certain purposes (e.g. only in education), are not allowed.
Found 47212 records

The purpose of this guidance document is to give drug and medical device manufacturers instructions on how to prepare clinical …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Guidance document Public release clinical information confidential information would be made publicly available following regulatory decision.

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

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Canada's Access to Medicines Regime WTO-member countries countries eligible to import under the Regime.

Governments can override patent rights when necessary. In such instances, the government authorizes a third party to use the patented …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Canada's Access to Medicines Regime compulsory licences override patent rights authorizes a third party patented invention patent holder's permission.

Countries with insufficient or no manufacturing capacity in the pharmaceutical sector can benefit from participating in Canada's Access to Medicines …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Country access Canada's Access to Medicines Regime insufficient or no manufacturing capacity in the pharmaceutical sector import a lower cost drug and medical devices.

We are working to make clinical information about the safety and efficacy of drugs and medical devices available to the …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Public release clinical information confidential information would be made publicly available following regulatory decision.

For the purpose of this guidance document, Health Canada has determined that certain submissions and applications involving human or disinfectants …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Administrative process of submission and application submission and application of human and disinfectant drugs.

The Special Access Programme (SAP) provides access to nonmarketed drugs for practitioners treating patients with serious or life-threatening conditions when …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Special Access to Drugs and Health Products Special Access Programme access to nonmarketed drugs.

The updated regulations will help drug makers understand what information should be included in their drug submissions. This will help …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Improving access to generic drugs regulatory review of drugs and devices.

This project will build new review pathways for those drugs shown to meet health care system needs. The outcome for …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Priority review faster access to drugs health care system needs.

This project will result in Health Canada and Health Technology Assessment (HTA) organizations working together. This will allow them to …

Record Modified: Sep 17, 2020
Record Released: Sep 17, 2020
Publisher: Health Canada
Formats: HTML
Keywords: Early scientific advice Health Canada and Health Technology Assessment.