The MHRA is undertaking a public consultation on proposals to introduce a scheme in the UK that will provide access to certain new medicines before they are formally licensed. The detail of the scheme, the types of medicines that may be made available and the stage in their development at which we expect that companies will apply are set out in this document.


The UK MHRA is consulting for 12 weeks in accordance with the Government’s Code of Practice. Comments on the proposals are invited by 5 October 2012 at the latest. Once they have received and analysed the responses to this consultation, they will make a decision on implementing the Scheme in the autumn.


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


Posted on the UK MHRA website on 17 July 2012