Regulation on Medicinal Products for Paediatric Use

The Regulation of the European Parliament and of the Council on Medicinal Products for Paediatric Use EC 1901/2006 and EC 1902/2006 entered into force in all the Member States of the European Union on 26 January 2007. The regulation became law during Finland's presidency. Preparations were commenced in December 2000 by the decision of the EU Council of Ministers during the French presidency.

This Regulation aims to facilitate the development and accessibility of medicinal products for use in the paediatric population; to ensure that medicinal products used to treat the paediatric population are subject to ethical research of high quality and are appropriately authorised for use in the paediatric population; and to improve the information available on the use of medicinal products in the various paediatric populations.

These objectives should be achieved without subjecting the paediatric population to unnecessary clinical drug trials. Nor should research into paediatric use delay the authorisation of new medicinal products intended for other age populations.