Variations to marketing authorisations

A new European variations Regulation came 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.

Following a consultation in 2010 it was agreed 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

Some important changes introduced by the new Regulation and adopted in the UK are:

  • A change to the minor variations of Type IA (Type IA notifications) from being a “Tell-and-Do” procedure to a “Do-and-Tell” procedure with notification to the MHRA either immediately or within 12 months of implementation. The procedure timescale has been extended to 30 days
  • Inclusion of Extension Applications under the broad definition of a variation (where previously these were excluded by the Annex to the old Regulation.) Extension Applications granted in the UK will however continue to be authorized with a new product licence and a unique Summary of Product Characteristics
  • • A change in ‘default category’ from a Type II variation (as in the old Regulation) to a Type IB in circumstances where the change is not defined in the Regulation or its associated classification guidance