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16th Feb 2012, 04:57 PM
#1
EU marketed drug unlicenced in UK and used as an IMP
If a drug has a marketing authorisation in Germany but has not been licenced in the UK, what is the position regarding the use of this as an IMP? It is available from a distributer in the UK as commercial product with an English label. Would we require evidence of an MIA (IMP) from the manufacturer?
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