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Regulation (EC) No 1901/2006 Article 43

Regulation (EC) No 1901/2006 Article 43

Article 43

1.   On the basis of the information referred to in Article 42 and after consulting the Commission, the Member States and the interested parties, the Paediatric Committee shall establish an inventory of therapeutic needs, in particular with a view to identifying research priorities. The Agency shall make the inventory public at the earliest by 26 January 2009 and at the latest by 26 January 2010 and shall update it regularly. 2.   In establishing the inventory of therapeutic needs, account shall be taken of the prevalence of the conditions in the paediatric population, the seriousness of the conditions to be treated, the availability and suitability of alternative treatments for the conditions in the paediatric population, including the efficacy and the adverse reaction profile of those treatments, including any unique paediatric safety issues, and any data resulting from studies in third countries.

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Other provisions in TITLE VI — COMMUNICATION AND COORDINATION

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 43 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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