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Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance) article 3 CELEX: 02006R1901-20190128 1. By 26 July 2007, a Paediatric Committee shall be established within the European Medicines Agency set up under Regulation (EC) No 726/2004, hereinafter ‘the Agency’. The Paediatric Committee shall be considered as established once the members referred to in Article 4(1)(a) and (b) have been appointed.
The Agency shall fulfil the secretariat functions for the Paediatric Committee and shall provide it with technical and scientific support. 2. Save where otherwise provided for in this Regulation, Regulation (EC) No 726/2004 shall apply to the Paediatric Committee, including the provisions on the independence and impartiality of its members. 3. The Executive Director of the Agency shall ensure appropriate coordination between the Paediatric Committee and the Committee for Medicinal Products for Human Use, the Committee for Orphan Medicinal Products, their working parties and any other scientific advisory groups.
The Agency shall draw up specific procedures for possible consultations between them. |