The MHRA is undertaking a short public consultation on proposals to amend the Medicines (Products for Human Use) (Fees) Regulations 2012 (SI 2012 No 504) to reflect minor changes to wording of European Commission Regulation EC/1234/2008 (concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products) which will become effective 90 days after publication in the Official Journal (2 November 2012).


We are consulting for four weeks as the amendments are very minor and only concern the inclusion of a single new reference where appropriate to ensure compliance with an updated European Commission Regulation which will be immediately binding when the relevant sections become effective. Comments on the proposals are invited by 12 November 2012 at the latest.


Comments should be sent either by post to Karen Salawu, 5th Floor, 151 Buckingham Palace Road, London, SW1W 9SZ or by email by 5 October 2012.


Posted on the UK MHRA website on 14 Aug 2012