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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 7 CELEX: 02006R1901-20190128 1. An application for marketing authorisation under Article 6 of Directive 2001/83/EC in respect of a medicinal product for human use which is not authorised in the Community at the time of entry into force of this Regulation shall be regarded as valid only if it includes, in addition to the particulars and documents referred to in Article 8(3) of Directive 2001/83/EC, one of the following: (a) the results of all studies performed and details of all information collected in compliance with an agreed paediatric investigation plan; (b) a decision of the Agency granting a product-specific waiver; (c) a decision of the Agency granting a class waiver pursuant to Article 11; (d) a decision of the Agency granting a deferral.
For the purposes of point (a), the decision of the Agency agreeing the paediatric investigation plan concerned shall also be included in the application. 2. The documents submitted pursuant to paragraph 1 shall, cumulatively, cover all subsets of the paediatric population. |