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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 (Text with EEA relevance) article 59 CELEX: 02004R0726-20220128 1. The Agency shall take care to ensure early identification of potential sources of conflict between its scientific opinions and those of other bodies established under Union ◄ law carrying out a similar task in relation to issues of common concern. 2. Where the Agency identifies a potential source of conflict, it shall contact the body concerned in order to ensure that any relevant scientific information is shared and to identify the scientific points which potentially conflict. 3. Where there is a fundamental conflict over scientific points and the body concerned is a Union ◄ agency or a scientific committee, the Agency and the body concerned shall work together either to resolve the conflict or to submit a joint document to the Commission clarifying the scientific points of conflict. This document shall be published immediately after its adoption. |
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 (Text with EEA relevance) article 59 CELEX: 02004R0726-20220128 4. Unless otherwise provided for in this Regulation, Regulation (EU) 2019/6 or Directive 2001/83/EC, where there is a fundamental conflict over scientific points and the body concerned is a body in a Member State, the Agency and the national body concerned shall work together either to resolve the conflict or to prepare a joint document clarifying the scientific points of conflict. Such joint document shall be published immediately after its adoption. |