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Pharmaceutical Industry Consultation Periods

Hogan Lovells

MDCG guidance for consultations of authorities on devices incorporating a medicinal product

Hogan Lovells on

On 10 June 2020, the MDCG issued guidance MDCG 2020-12 on the transitional provisions concerning the consultation of authorities regarding devices incorporating a substance.....more

Smart & Biggar

Canada releases proposed amendments to Regulations governing patented medicines pricing

Smart & Biggar on

On December 2, 2017 Canada’s Governor-in-Council published proposed Regulations Amending the Patented Medicines Regulations (“the proposed Regulations”). The 75-day consultation period ends February 15, 2018. The proposed...more

Jones Day

EMA Calls for Public Consultation on Clinical Trial Protocol, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

Jones Day on

June 2017 The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014)...more

Smart & Biggar

The Pricing of Patented Drugs in Canada: Stakeholder Consultation Period Open Until June 28, 2017

Smart & Biggar on

The Patented Medicine Prices Review Board (PMPRB) regulates the price of patented medicines in Canada by determining whether a price is excessive. The Board is revisiting its approach to pricing, and has now released a...more

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