Regulamentul (ce) nr. 1901/2006 al parlamentului european şi consiliului, privind medicamentele de uz pediatric. Extinderea duratei certificatelor ...
Regulation (EC) no. 1901/2006 of the European Parliament and the Council on medicinal products for pediatric use. Extend to supplementary protection..

Summary/Abstract: The article aims to bring forward Regulation (EC) No. 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use, effective since January 26th, 2007, and its consequences upon the monopoly secured to holders of patents or supplementary protection certificates for medicinal products. The regulation aims to facilitate the development and availability of medicines used in the paediatric population, on strength of introducing obligations, incentives and rewards in connection with clinical trials assessing this use. All applications for marketing approval for new medicinal products and those relating to new indications, new formulations and new routes of administration of medicinal products already approved, must include the results of the studies undertaken and details of all information collected in accordance with a Paediatric Investigation Plan (PIP). The reward thereto is that the holder of patent or supplementary protection certificate for the relevant medicinal product is entitled to a 6-month extension of the certificate’s duration.

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