Latest News

New System for Variations

9/3/2010

Following the introduction of the new system for variation applications, we have been able to help many companies use it to their advantage.  While there is clarity on its applicability to marketing authorisations (MAs) for human medicinal products approved through the centralised, decentralised (DCP) and mutual recognition procedures (MRP), the picture is not so straightforward for purely national MAs, with Directive 2009/53/EC allowing a derogation for national MAs granted before 1st January 1998 and an extended deadline of 20th January 2011 before its provisions become binding.  Despite this, many member states have already rewritten their national rules, adopting elements of the new system for national MAs and streamlining their national variation procedures with those for MRP/DCP.  With a solid understanding of the prevailing requirements, wherever you hold marketing authorisations in Europe, we’ll be pleased to guide you.