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PMPRB update: Revised compliance timelines for grandfathered and gap medicines and proposed regulatory amendments directed to CSPs | Smart & Biggar

PMPRB Updates: Definition of Gap Medicine amended, modified threshold for investigating the price of new patented medicines | Smart & Biggar

Consultation results On March 17, 2021 the Patented Medicine Prices Review Board (PMPRB) announced the result of the Consultation opened in January (reported here) regarding the definition of “Gap Medicine” and compliance timelines for Grandfathered and Gap Medicines. As proposed, the Guidelines will be amended such that a Gap Medicine will be defined as a medicine for which a Drug Identification Number (DIN) was assigned on or after August 21, 2019, and which was first sold in Canada by July 1, 2021. The PMPRB also clarified that a DIN must have been assigned to the medicine on or after August 21, 2019 but prior to July 1, 2021. The PMPRB will similarly proceed with its proposed revision to the compliance timeline for Grandfathered and Gap Medicines, such that

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