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 a duplex marketing authorisation procedure, the MEB can waive a full evaluation, and the proof of authorisation (marketing authorisation) can be quickly issued.
From 1 September 2015, a duplex marketing authorisation is only permitted for medicinal products that, upon filing the paperwork with the MEB:
- received marketing authorisation no more than 5 years ago, or for which a mutual recognition procedure (MRP) was completed successfully no more than 5 years ago (with The Netherlands as reference member state (RMS)), day 90 no more than five years ago, and
- and have an approved Risk Management Plan (RMP).
The duplex marketing authorisation procedure will remain possible for medicinal products authorised more than five years ago under the following supplementary conditions:
- The dossier for the duplex product will remain identical to the dossier for the reference product after marketing authorisation is issued.
- A mutual recognition procedure (MRP) cannot be initiated for the duplex product.
- The marketing authorisation for the duplex product cannot be transferred to a different (legal) entity.
- If the marketing authorisation for the reference product is withdrawn at the request of the marketing authorisation holder, a request for the withdrawal of the marketing authorisation for the duplex product must be filed within three months.
These additional conditions guarantee that the duplex product and the reference product remain identical, except for a few administrative particulars.