Discussion Papers

Each discussion paper explores one issue that has been identified as integral to the development of a new drug licensing system. The papers examine some of the challenges that must be answered by a modern drug framework. They do not attempt to provide solutions, which will come as a result of a consultation with the stakeholders.

The discussion papers have been themed by their general topics. Each paper contains questions for stakeholders and a request form that will be submitted directly to Health Canada. The feedback on these questions will inform the development of the new drug licensing framework. The deadline for submitting comments on these discussion papers is October 31, 2008.

In addition to the questions in each discussion paper, stakeholders can provide general feedback by submitting comments directly to the Progressive Licensing Project through their dedicated e-mail address: progressive_licensing@hc-sc.gc.ca.

• Overarching Issues
• Initial Market Authorization
• Exceptional Circumstances
• Drug Labelling
• Conditions Associated with Market Authorization
• Post-market Authorization
• Risk Management and Risk Communication
• Graduated System of Enforcement and Compliance

Contact information for the Progressive Licensing Project.