Authorisation procedures - The decentralised procedure
The decentralised procedure was introduced by Directive 2004/27/EC. As the mutual recognition procedure, it is also based on recognition by national authorities of a first assessment performed by one Member State. The difference lies in that it applies to medicinal products which have not received a marketing authorisation at the time of application.
How does the decentralised procedure work?
An identical application for marketing authorisation is submitted simultaneously to the competent authorities of the Reference Member State and of the Concerned Member States. At the end of the procedure, the draft assessment report, SPC, labelling and package leaflet, as proposed by the Reference Member State, are approved.