Obtaining Paediatric SPC Extensions in the European Union
This article was originally published in SRA
Executive Summary
New European Union legislation on paediatric data requirements for marketing authorisation applications came into effect in January 2007. Among other things, the so-called Paediatric Regulation offers a reward for conducting paediatric trials: a six-month extension to the supplementary protection certificate. In this article, we look at the details of the regulation (Regulation (EC) No 1901/2006)1, how companies should go about gaining the SPC extension and some of the pitfalls they may encounter along the way.
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