About the PMPRB Guidelines

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
• 2022 Proposed updates to the PMPRB Guidelines
• Decision resulting from the consultation on the PMPRB Price Review Approach During the Interim Period following publication of Amendments to the Patented Medicines Regulations
• Update – PMPRB Response to the April 14, 2022 statement from Minister of Health on the Coming-into-Force of the 2019 Regulations Amending the Patented Medicines Regulations
• Previous proposed updates to the PMPRB Guidelines
  This page contains material related to previous proposed versions of the PMPRB Guidelines that no longer apply following the publication of Amendments to the Patented Medicines Regulations.
• Consultation on the Guideline Monitoring and Evaluation Plan - Stakeholders were invited to help shape the GMEP by submitting feedback.