New Variations Regulation - key points to note
18 December 2009
The new ‘Variations Regulation’ (Commission Regulation 1234/2008) comes into force on 1st January 2010 and applies immediately to human and veterinary medicinal products authorised through the centralised and MRP/DCP routes. The applicability of this regulation will be formally extended to ‘purely National’ marketing authorisations at a later date. However, in line with many other European regulatory agencies, the IMB has taken the decision to implement the general principles of the new Regulation to all marketing authorisations from 1st January 2010. It is felt that having a single set of rules and procedures will simplify operation of the new regulation for both MA holders and the IMB.
The objective of this document is to outline the main changes which have been made to the handling of variations under the new Regulation and to explain how the IMB will deal with these variations. The topics covered below will also be covered at the IMB information day for the New Variations Regulation on 22nd January 2010 (for further information, please click here).
For full details please click below:
New Variations Regulation - key points to note
The new variation application form has been published on the European Commission website and must be used from 1 January 2010 for all marketing authorisation variations submissions. The published variation application form is still labelled as 'Draft' but this is the version that should be used until the final version is available.
Draft Application for variation to a marketing authorisation.
A user guide on how to use the new variation application form has also been published by the European Medicines Agency and CMDh.
Explanatory notes on Variation Application Form (Human medicinal products only) (January 2010)