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In addition to the definitions laid down in Article 1 of Directive 2001/83/EC, the following definitions shall apply for the purposes of this Regulation: 1) ‘paediatric population’ means that part of the population aged between birth and 18 years; 2) ‘paediatric investigation plan’ means a research and development programme aimed at ensuring that the necessary data are generated determining the conditions in which a medicinal product may be authorised to treat the paediatric population; 3) ‘medicinal product authorised for a paediatric indication’ means a medicinal product which is authorised for use in part or all of the paediatric population and in respect of which the details of the authorised indication are specified in the summary of the product characteristics drawn up in accordance with Article 11 of Directive 2001/83/EC;

4) ‘paediatric use marketing authorisation’ means a marketing authorisation granted in respect of a medicinal product for human use which is not protected by a supplementary protection certificate under Regulation (EEC) No 1768/92 or by a patent which qualifies for the granting of the supplementary protection certificate, covering exclusively therapeutic indications which are relevant for use in the paediatric population, or subsets thereof, including the appropriate strength, pharmaceutical form or route of administration for that product.