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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 55 CELEX: 02006R1901-20190128 ‘(t) taking decisions as referred to in Article 7(1) of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use ().
3) the following Article shall be inserted:
‘Article 73a
Decisions taken by the Agency under Regulation (EC) No 1901/2006 may form the subject of an action before the Court of Justice of the European Communities under the conditions laid down in Article 230 of the Treaty.’. |
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 55 CELEX: 02006R1901-20190128 Regulation (EC) No 726/2004 is hereby amended as follows:
1) Article 56(1) shall be replaced by the following:
‘1. The Agency shall comprise: (a) the Committee for Medicinal Products for Human Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for human use; (b) the Committee for Medicinal Products for Veterinary Use, which shall be responsible for preparing the opinion of the Agency on any question relating to the evaluation of medicinal products for veterinary use; (c) the Committee on Orphan Medicinal Products; (d) the Committee on Herbal Medicinal Products; (e) the Paediatric Committee; (f) a Secretariat, which shall provide technical, scientific and administrative support for the committees and ensure appropriate coordination between them; (g) an Executive Director, who shall exercise the responsibilities set out in Article 64; (h) a Management Board, which shall exercise the responsibilities set out in Articles 65, 66 and 67.’;
2) in Article 57(1), the following point shall be added: |