Brussels, 05/05/2010 (Agence Europe) - On Wednesday 5 May, the European Commission sent a reasoned opinion to Germany for incorrectly applying EU rules on well established medicinal use when authorising medicinal products pursuant to Directive 2001/83/EC. EU law foresees a simplified authorisation procedure for medicinal products containing an active substance that has been extensively used for at least a decade in the European Union and is therefore considered to have a proven track record of safety and efficacy. This procedure allows an applicant to rely on existing scientific literature on the active substance, instead of conducting tests and clinical trials for the product. Information available to the Commission suggests that when calculating the period of 10 years, German authorities take less extensive use of the active substance into account, such as clinical trials. This inaccurate calculation of the time period infringes the terms of Directive 2001/83/EC and obscures the clear separation between different authorisation procedures, the Commission states in a pres release. Berlin has two months in which to react. If no arrangement is reached, the Commission may refer the matter to the EU Court of Justice. (O.L./transl.jl)