MEB 16: Duplex marketing authorisation

A duplex marketing authorisation is a marketing authorisation for a product of which the dossier is identical to that of a product which is already authorised. In principle, this concerns a standard marketing authorisation, and the dossier must meet the known legal criteria. In a duplex marketing authorisation procedure, the MEB can waive a full evaluation, and the proof of authorisation (marketing authorisation) can be quickly issued.

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