European Medicines Agency (EMA) v PTC Therapeutics International Ltd.

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• European Medicines Agency (EMA) v PTC Therapeutics International Ltd.

This document cites

• Evonik Degussa GmbH v European Commission.
• European Commission v Federal Republic of Germany.
• European Medicines Agency (EMA) v AbbVie Inc. and AbbVie Ltd.
• European Commission v Republic of Malta.
• European Commission v Pilkington Group Ltd.



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• European Commission v Éditions Odile Jacob SAS.
• European Commission v Bilbaína de Alquitranes, SA and Others.
• AGC Glass Europe SA and Others v European Commission.
• European Commission v Agrofert Holding a.s..
• Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
• Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
• Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (Text with EEA relevance)Text with EEA relevance
• Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents
• Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (Text with EEA relevance)
• Consolidated version of the Treaty on the Functioning of the European Union 2016/C 202/01
• Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance
• Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products
• Regulation (EU) No 1027/2012 of the European Parliament and of the Council of 25 October 2012 amending Regulation (EC) No 726/2004 as regards pharmacovigilance Text with EEA relevance
• Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance Text with EEA relevance