ARTICLE · 09 NOVEMBER 2020
Few Significant Changes Made In Final PMPRB Guidelines
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Few significant changes made in final PMPRB Guidelines
Life Sciences Regulatory & Compliance
Chemical & Biotechnology
Pharmaceutical & Biologics
Abigail Smith, Daphne Lainson and Nancy Pei
November 04, 2020
As briefly reported here, on October 23, 2020, the Patented Medicine Prices Review Board (PMPRB) published the final version of its Guidelines.
CanadaFood, Drugs, Healthcare, Life Sciences
Update: On November 23, Innovative Medicines Canada and a
number of pharmaceutical companies commenced an application for
judicial review of the final Guidelines. See also the PMPRB's
November 20, 2020 webinar slides here. The definition of "Gap
medicines" and compliance timelines were updated following a
consultation (see article here), as were compliance timelines for
Grandfathered and Gap medicines (see article here). A consultation is underway regarding a
further update to the definition of Gap medicine, and other changes
(see article here).
As briefly reported here, on October 23, 2020, the Patented
Medicine Prices Review Board (PMPRB) published the final version of its Guidelines. These
Guidelines operationalize the amendments to the Patented
Medicines Regulations scheduled to come into force on January
1, 2021 (see our article here). The Guidelines state they are not
binding and may be revisited by the PMPRB "in light of
experience and changing
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