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Regulation (EC) No 1901/2006 Article 4

Regulation (EC) No 1901/2006 Article 4

Article 4

1.   The Paediatric Committee shall be composed of the following members: (a) five members, with their alternates, of the Committee for Medicinal Products for Human Use, having been appointed to that Committee in accordance with Article 61(1) of Regulation (EC) No 726/2004. These five members with their alternates shall be appointed to the Paediatric Committee by the Committee for Medicinal Products for Human Use; (b) one member and one alternate appointed by each Member State whose national competent authority is not represented through the members appointed by the Committee for Medicinal Products for Human Use; (c) three members and three alternates appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent health professionals; (d) three members and three alternates appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent patient associations. The alternates shall represent and vote for the members in their absence. For the purposes of points (a) and (b), Member States shall cooperate, under the coordination of the Executive Director of the Agency, in order to ensure that the final composition of the Paediatric Committee, including members and alternates, covers the scientific areas relevant to paediatric medicinal products, and including at least: pharmaceutical development, paediatric medicine, general practitioners, paediatric pharmacy, paediatric pharmacology, paediatric research, pharmacovigilance, ethics and public health. For the purposes of points (c) and (d), the Commission shall take into account the expertise provided by the members appointed under points (a) and (b). 2.   The members of the Paediatric Committee shall be appointed for a renewable period of three years. At meetings of the Paediatric Committee, they may be accompanied by experts. 3.   The Paediatric Committee shall elect its Chairman from among its members for a term of three years, renewable once. 4.   The names and qualifications of the members shall be made public by the Agency.

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Other provisions in CHAPTER 2 — Paediatric committee

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 4 of Regulation (EC) No 1901/2006 (LawPlayer, data as of 2026-07-04)

© European Union, https://eur-lex.europa.eu, 1998-2026. Reuse authorised under Commission Decision 2011/833/EU, provided the source is acknowledged.

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