Pangaea Express: PMPRB Notice and Comment
As neither the existing nor the October 2020 Guidelines address the set of regulations which will come into force on July 1, 2022, it is necessary for the Board to consult on a new set of guidelines later this year. At this time, the Board expects to begin consulting on the new guidelines in September, with a view to having a final set of guidelines in place by the end of the calendar year.
The PMPRB issued a Notice and Comment - PMPRB Price Review Approach During the Interim Period following publication of Amendments to the Patented Medicines Regulations. In the period between the coming into force of the new Patented Medicines Regulations and the final publication of a corresponding set of guidelines (“Interim Period”), the PMPRB is proposing to adopt a “status quo” approach to carrying out its regulatory mandate. The PMPRB has stated in the notice they will not conduct a price review of any new patented medicines or open investigations in respect of them until the new guidelines come into effect.
The PMPRB invites stakeholders to comment on its proposed approach for conducting interim period reviews until July 18, 2022.
For more information, please contact Marla Weingarten.