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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?
Dear Linda,
If the drug is licenced in EU, you dont need any evidence of MIA (IMP), but you must need english version of SmPC. As you can see the proof of product licence number in the SmPC. But you need a copy of invoice to show that you bought it from approved supplier. Hope this helps.