MEDIMARK EUROPE

The publication of the Commission’s revision proposal to the Council and European Parliament should be done during this month of September 2012. However, It will be only the beginning of the Ordinary Legislative Procedure where the Council and European Parliament discuss the proposal and bring amendments in order to agree upon a common text which will be most likely published in early 2014 before the new European Parliamentary elections.Since the text should be published as Regulations and not as Directives, it will be immediately applicable. However, a transition period should be given in order to allow the manufacturers, notified bodies and national competent authorities for implementation of some of the new rules.