Version 3 of Module SUB06, released in February 2010, is fully up to date with the new variations legislation. Significant changes to variations classification and procedures in the European Economic Area, brought about by the implementation of Regulation (EC) 1234/2008 from 1 January 2010, are set out. New provisions for grouping of variations into a single submission and for worksharing of assessment are described.

The module applies to marketing authorisations granted by any of the multinational procedures available in the EEA, which comprises the 27 member states of the European Union plus Norway, Iceland and Liechtenstein. It applies also to purely national authorisations in some member states now and will apply to all such by 2011.