In April 2012, following consultation with medicines trade associations and member companies we announced some procedural changes concerning the requirement to submit full-colour mock-ups of labels and patient leaflets.  In the last year we have received a number of requests for a copy of the guidance, so are now providing this at the link below.


Guidance on submitting label and leaflet mock-ups following variations


Posted on the UK MHRA website on 13 February 2013