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EUCOPE News- and Pressarchives

Update: revised EUCOPE position paper on international reference pricing

Thursday, September 8th, 2016 in News, Newsletter, Uncategorized

EUCOPE updated its position paper on International Reference Pricing. You will find the document here: updated-position-paper-price-differences-in-the-eu

Open letter to European political institutions asks for transparency and collaboration as negotiations on a revised medical device framework near an end

Friday, March 11th, 2016 in News, Newsletter, Press Releases

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) has today published an open letter sent to Members of the European Parliament (MEPs), the European Commission and Member State representatives, all of whom are negotiating the proposed revision to the legislative framework governing the approval and sale of medical devices in the ... read more...

EUCOPE comments on the Draft Notice on Significant Benefit for Orphan Medicinal Products

Thursday, March 3rd, 2016 in News, Newsletter, Press Releases

On 15 February, EUCOPE has submitted its comments on the Draft Commission Notice on the Application of Articles 3, 5 and 7 of Regulation (EC) No 141/2000 on Orphan Medicinal Products (OMPs) defining and explaining the criteria that lead to an OMP designation. Given that these guidelines have remained unchanged for ... read more...

EUCOPE files complaint against French law promoting government-initiated off-label use

Wednesday, September 2nd, 2015 in News, Newsletter, Press Releases

The European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and the European Association for Bioindustries (EuropaBio), have today filed a complaint with the European Commission against the French “RTU Regime”, whose first implementing act for economic reasons will be effective as of 1 September ... read more...

Provisions of the Clinical Trial Regulation (EC) No 536/2014 and the implications on Regulatory Affairs

Thursday, July 16th, 2015 in News

The Clinical Trial Regulation has been adopted by the European Parliament on 2 April 2014 and has entered into force on 16 May 2014. However the application is linked to the full functionality of the EU Clinical Trial portal and database currently being set up. Therefore, it is expected that ... read more...