Following authorisation of a veterinary medicinal product, the terms of the marketing authorisation may subsequently be varied.
Variation notifications, for example the addition of a new manufacturing site or a new indication, are defined in Commission Regulation (EC) 1084/2003 as either ‘minor’ (Type I) variations or ‘major’ (Type II) variations.
Variations Regulation - Key Points to Note
The 'Variations Regulation' (Commission 1234/2008) came into force on 1 January 2010 and applies to medicines authorised through the centralised and mutual-recognition or decentralised procedures. 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 took the decision to implement the general principles of the new Regulation to all marketing authorisations from 1 January 2010. It is felt that having a single set of rules and procedures will simplify operation of the new Regulation for both marketing authorisation holders and the IMB.
For more information on the new variations regulation and how the IMB is implementing it, please refer to the following document: New Variations Regulation - Key points to note
Variation Process
For a veterinary medicinal product which was authorised by the IMB under national procedure, all variation applications should be made directly to the IMB. Where a product has been authorised through the mutual recognition or decentralised procedure, applications must be made to the reference member state (RMS) and concerned member states (CMS) involved in the procedure. The RMS is responsible for establishing a timetable for the procedure in consultation with the applicant.
Further information on variations is available in:
Variation applications for both national and mutual recognition procedures (Type 1A, 1B and Type II) are made using the EU Application for Variation to a Marketing Authorisation which can be downloaded from the IMB website.
Notification of approval of all national and mutual recognition/decentralised variations is by automatic email. For mutual recognition/decentralised variations, the applicant will also receive notification from the RMS. If the variation involves a change to the SPC, an updated SPC will be published on the IMB website within 14 days.
For products authorised by the European Commission using the centralised procedure, variation applications must be submitted to the European Medicines Agency (EMA). For more information, please consult the EMA website.