New Variations Regulations - Key Points to Note
17 February 2011
The new ‘Variations Regulation’ (Commission Regulation 1234/2008) came 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.
New Variations Regulations - Key Points to Note