Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
A new European variations regulation comes into force on 1 January 2010 and replaces Regulations 1084/2003/EC and 1085/2003/EC. Commission Regulation 1234/2008 concerns variations handled in Mutual Recognition or Centralised Procedures.
However, following a consultation earlier this year UK health ministers have agreed that the UK will adopt these new rules for all variations to marketing authorisations, including those held only in the UK. Therefore from 1 January 2010, the new classification systems and procedural rules will apply in full. In parallel, an amending UK fees regulation is to be implemented in order to establish fees for the new types of work specified in the Commission regulation.
New UK guidance has been produced to assist those making variation applications to the MHRA as from 1 January 2010, following the implementation of a new Commission regulation and its adoption for UK national variations.
UK national MA variations guidance 
