On 12 December 2006, the European Parliament and the Council adopted Regulation (EC) No. 1901/2006 on medicinal products for paediatric use (see our previous News article, ‘Patent Term Incentives to Improve Paediatric Medicines’). The regulation will enter into force, with direct effect in member states, on 26 January 2007.

The Regulation introduces a series of obligations for pharmaceutical companies to develop medicines for use in children. The obligations are staggered in terms of their entry into force, depending on the type of medicinal product concerned. In each case where a product is protected by a supplementary protection certificate (SPC), or a patent eligible for a SPC, compliance with the requirements of the Regulation will add a six-month extension to the SPC. This extension will be available even if the paediatric studies fail to lead to a paediatric indication, provided the results of the studies are reflected in the summary of product characteristics.

For medicinal products not authorised by 26 January 2007, there will be an obligation to include either the results of paediatric studies, or a decision of the European Medicines Evaluation Agency on a waiver or deferral of such studies, in an application for marketing authorisation. This obligation will enter into force as of 26 July 2008.

For authorised products protected by a patent or a SPC, paediatric study results, or a waiver/deferral decision, must be supplied with applications for variation or extension of the marketing authorisation (i.e., to introduce a new indication, dosage form or route of administration). This obligation will apply as of 26 January 2009.

For the text of the Regulation, click here or type the following URL into your browser.  

http://eur-lex.europa.eu/LexUriServ/site/en/oj/2006/l_378/l_37820061227en00010019.pdf

Nicholas Jones
22 January 2007