Please note that the European Commission published updated procedural and classification guidance regarding variations on 16 May 2013.
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The updates become effective on 4 August 2103 and reflect changes to Commission Regulation 1234/2008 (external link) introduced by Commission Regulation 712/2012 (external link), including the application of the procedures to variations to purely national marketing authorisations. The classification guideline has been updated to reflect adaptation to technical progress, changes introduced in the basic legislation, and the experience acquired to date and will replace the current guidance. Consequently, the updated classification guideline should be used for any variation submitted on or after 4 August. It is therefore important that any individuals involved in the preparation of variation submissions familiarise themselves with the updated guidance and take it into immediate consideration for any new proposed grouping requests for variations that are likely to be submitted after it becomes effective.
Further detailed guidance will be issued in due course as part of a general update to the Variations specific website pages.