When Will the New Variations Regulation Come into Operation?

As a part of the Heads of Medicines Agencies, the CMD(h) (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human) is publishing a number of interesting documents . Especially the questions-and-answers sections give valuable tips regarding the point of view of the European registration and supervisory authorities. These lists are updated continuously.

The latest addition No. 31 answers the question if and until when the former variations regulation is to be implemented or if the new version is already in force. This question is ultimately decided upon by the date on which the variations application reaches the competent authority of the Reference Member State. If it arrives after 31 December 2009, the new Variations Regulation (EC) No. 1234/2008 applies.

As in the past, however, for the time being, the Regulation only applies to the following types of application:

  • Centralised marketing authorisations
  • Authorisations under the Mutual Recognition Procedure (MRP)
  • Decentralised Procedures (DCP)
  • Procedures undergoing a referral

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

In the meantime, a draft form for variations applications has been published. This preliminary form may be used until the official version has been published.

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

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