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.

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