News on Change Control/Variations

New Guidelines applicable as of Aug. 4, 2013 covering updated Classifications
and Procedural Aspects

The European Variations Regulations were updated and will also apply to nationally authorized products as of August 4, 2013.

Now, all necessary details are defined in one common document covering the classification of changes as well as the procedural aspects.

The classifications were also updated in line with the latest changes of regulations and based on experience gained over the last years. This is essential for your next Change Control decisions. 
                                                                                                      Alea iacta est.
You can find the updated classifications as well as the procedural aspects in the new “Guidelines on the details of the various categories of variations, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products and on the documentation to be submitted pursuant to those
published on Eudralex (see:

Update your change control system now, implement your changes fast and stay compliant within the new regulatory environment.

Do you want to know how to:
  • benefit from the new guideline and how to simplify your processes?
  • use a change management protocol?
  • write good dossiers?

Then, contact us at

We know the details of these new regulatory requirements. We help you to speed up your change processes and to adapt your change control system accordingly. You can benefit from our long term-experience in dealing with worldwide changes.

We guide you through the process of implementing changes and filing your variations according to these new regulations.


Phone +49 (0) 7251/305 529
Fax +49 (0) 7251/305 528


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EU: New Variation System in force as of Jan 1, 2010. Filing of variations will be faster, easier, and more flexible. Have you considered that your Change Control System needs to be updated accordingly?
EU: Centralised Marketing Authorisation Procedure for ATMPs needed Have you already filed your application? The time clock is ticking. Transitional periods will be over soon.
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