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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 42 CELEX: 02006R1901-20190128 Member States shall collect available data on all existing uses of medicinal products in the paediatric population and shall communicate these data to the Agency by 26 January 2009.
The Paediatric Committee shall provide guidance on the content and the format of the data to be collected by 26 October 2007. |