About the PMPRB Guidelines
The coming-into-force of the amended Patented Medicines Regulations (“Regulations”) has been further delayed past July 1, 2021, consequently, the new Guidelines will not be coming into effect on July 1, 2021.
The PMPRB Guidelines, which are issued pursuant to subsection 96(4) of the Patent Act, are intended to provide transparency and predictability to patentees regarding the triage and review process typically engaged in by public servant employees of the PMPRB in assessing whether a patented medicine appears to be priced excessively in any market in Canada. The Guidelines also provide an overview of the processes that patentees should be aware of regarding their filing obligations under the Patented Medicines Regulations.
- Compendium of Policies, Guidelines and Procedures – These Guidelines remain in effect until December 31, 2021.
- New PMPRB Guidelines – The updated Guidelines, which will take effect on January 1, 2022.
- Decision resulting from the consultation on the definition of Gap medicines and the timeline for compliance
- Written response to questions from the House of Commons Standing Committee on Health on November 23 and 27, 2020 (PDF 1.5 MB)
- Webinars for patentees
- Public Webinar on the PMPRB Guidelines: November 20, 2020 (PDF 1.2 MB)
- Guidelines consultation portal – Review the consultation process that led to the updated Guidelines, including feedback provided by stakeholders
- Consultation on the Guideline Monitoring and Evaluation Plan - Stakeholders were invited to help shape the GMEP by submitting feedback .
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