Submission of labels and leaflets in the UK
pharmafile | April 5, 2012 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing |Â Â Labelling, Wainwright AssociatesÂ
The MHRA has announced procedural changes concerning the requirement to submit full-colour mock-ups of labels and patient leaflets for medicinal products in the UK. As a general summary, the MHRA no longer requires mock-ups of the labels or leaflet to be submitted at the start of a procedure; the agency now provides the option of accepting Word versions such as the QRD template at the start of procedure, with the mock-ups to follow before marketing authorisation approval or marketing implementation. This brings it more into line with the approach followed by other European Member States. Our product information specialists will be pleased to advise you on the specific implications for your pre- and post-authorisation submissions. Please contact us at enquiries@wainwrightassociates.co.uk or telephone +44 (0)1628 530554.
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