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.
We are 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 we have received and analysed the responses to this consultation, we will make a decision on implementing the scheme in the autumn.
Responses to the consultation will be published on the MHRA’s website (unless individual respondents ask us not to publish their response).
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.