Paediatric Epilepsy Syndromes and their Surgical Treatment

Abstract

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents ►B COMMISSION REGULATION (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance) (OJ L 334, 12.12.2008, p. 7) concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (1), and in particular Article 39(1) thereof, Having regard to 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 (2), and in particular Article 35(1) thereof, Having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (3), and in particular of Article 16(4) and Article 41(6) thereof, Whereas: (1) The Community legal framework regarding variations to the terms of marketing authorisations is laid down in Commission Regulation (EC) No 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authori­ sation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State (4) and Commission Regulation (EC) No 1085/2003 of 3 June 2003 concerning the examination of vari­ ations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products falling within the scope of Council Regulation (EEC) No 2309/93 (5). In the light of practical experience in the application of those two Regulations, it is appropriate to proceed to their review in order to establish a simpler, clearer and more flexible legal framework, while guaranteeing the same level of public and animal health protection. (2)