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 – These Guidelines are currently in effect.
• 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
  • New PMPRB Guidelines – The updated Guidelines, set to take effect once the amended Patented Medicines Regulations (“Regulations”) come into Force.
    • Decision resulting from the consultation on the definition of Gap medicines and the timeline for compliance
      • Backgrounder on the Board’s decision
      • Submissions received during the month-long consultation
    • 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
      • Online Filing Tool & Transition Measures for Grandfathered and Gap Medicines - June 15, 2021 (PDF 2 MB)
      • Online Filing Tool - Monday, December 7, 2020 (PDF 1.7 MB)
      • Transition period for Grandfathered and Gap medicines & determination of the MLP - December 10, 2020 (PDF 250 KB)
    • 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 .