European Commission: Variations (codecision part): publication of amendments to Directive 2001/82/EC and Directive 2001/83/EC.

Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products, has been published in the Official Journal on 30 June 2009. This Directive is part of a global revision of the legal framework on variations to make the overall system clearer, simpler and more flexible and it amends the legal basis for the adoption of Community rules on variations in order to harmonise those rules for all authorised medicines in the EU.