Good Clinical Practice Guide
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Thread: EU marketed drug unlicenced in UK and used as an IMP

  1. #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?

  2. #2
    Forum Member
    Join Date
    Nov 2011
    Location
    London
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    20
    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.

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