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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 11 CELEX: 02006R1901-20190128 1. Production of the information referred to in point (a) of Article 7(1) shall be waived for specific medicinal products or for classes of medicinal products, if there is evidence showing any of the following: (a) that the specific medicinal product or class of medicinal products is likely to be ineffective or unsafe in part or all of the paediatric population; (b) that the disease or condition for which the specific medicinal product or class is intended occurs only in adult populations; (c) that the specific medicinal product does not represent a significant therapeutic benefit over existing treatments for paediatric patients. 2. The waiver provided for in paragraph 1 may be issued with reference either to one or more specified subsets of the paediatric population, or to one or more specified therapeutic indications, or to a combination of both. |