The New Variations System - what is the current situation?

From 1 January 2010, the modified European system for handling variations to the terms of marketing authorisations comes into force (Commission Regulation (EC) No 1234/2008). This means that the EMEA will process variations applications received after 1 January 2010 according to the new variations system. As before the directive only applies to the following types of marketing authorisation:

  • marketing authorisations under the Centralised System
  • marketing authorisations granted under the Mutual Recognition Procedure (MRP)
  • Decentralised Procedures (DCP)
  • authorisations granted following a referral

National authorisations will not be affected until Directive 2009/53/EC has been transposed into national law. This should be done by 20 January 2011, and the new procedure shall then be applied at least to all exclusively national authorisations granted after 1 January 1998. For authorisations granted before this date, the new system is meant to be optional for the member states.

However, two things are necessary before this can be implemented: a guideline on procedural questions and a guideline for the classification of variations. Both have to be translated after their publication (they will be guidelines by the European Commission). Both are planned to be finalised by the end of 2009. A new form for the variations applications is also meant to be released. We will keep you up to date.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK

Conference Recommendations

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK