As part of the Commissions initiative to a â€šBetter Regulation of Pharmaceuticals the review of the regulatory framework on variations has been started in a 3-steps-approach.
By now, two steps were finalized:
- Step 1: Review of the content of the current Variations Regulations (1084/2033; 1085/2003) (comitology) by adoption Variations Regulation 1234/2008
- Step 2: Change to the legal basis of the Variations Regulation (co-decision) by adopting Directive 2009/53/EC amending Directives 2001/82/EC and 2001/83/EC
The last major Step (3) needs still to be taken: Updating the Variations Regulation to include Purely national marketing authorisations (comitology).
As a consequence, the revised regulatory framework for variations will apply from 01 January 2010 for medicinal products granted under MRP/DCP and the Centralised Procedure.
The GtDRA chapter B.8 have been updated accordingly.