Regulation (EC) No 1901/2006 Article 53

Article 53

In Article 11 of Directive 2001/20/EC, the following paragraph shall be added: ‘4. By way of derogation from paragraph 1, the Agency shall make public part of the information on paediatric clinical trials entered in the European database in accordance with the provisions of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use ( *2 ) . ( *2 ) OJ L 378, 27.12.2006, p. 1 .’ "

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CitationArticle 53 of Regulation (EC) No 1901/2006 (LawPlayer, data as of 2026-07-04)

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