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Status Quo of the Commission Proposal on the new Medical Devices Regulation

Friday, November 1st, 2013 in News

The Plenary of the European Parliament has voted on the Commission Proposal for a Medical Devices Regulation and the amendments tabled by the rapporteur, Dagmar Roth-Behrendt, and other Committee members. We consider it to be very positive that certain amendments concerning substance-based medical devices and medical devices utilised in the process ... read more...

Protected: EUCOPE Board Meeting 21 February 2013

Friday, March 15th, 2013 in News

EUCOPE - Board Meeting 21 02 2013 Lantrès - Pricing and Reimbursement of Medicinal Products in France Buljovcic - ATMP Regulation Dettling - Demarcation MP and MD 210213 Salvatore -  EMA transparency

Market Access for Medicines and Medical Devices on 29 April in Paris

Thursday, February 28th, 2013 in News

The next meeting of our ‘P&R / Market Access’ Working Group will take place on 29 April in Paris in collaboration with our member organization Field Fisher Waterhouse (11:00 am to 5:00 pm, Cercle de l'Union Interalliée, 33, rue du Faubourg Saint-Honoré, 75008 Paris, France). Topics to be addressed will ... read more...

New rates of EMA fees for orphan drugs from 1.1.2013

Monday, December 17th, 2012 in News

Companies applying for designated orphan medicines pay reduced fees for regulatory activities to the EMA. This includes reduced fees for marketing-authorization applications, inspections before authorization, applications for changes to marketing authorizations made after approval and annual fees. Please find here a letter by EMA informing about the changed rates for fee ... read more...