DCP | Decentralised Procedure

Q: DCP | Decentralised Procedure

Decentralised Procedure for EU marketing authorisation The Decentralised Procedure (DCP) is a European route for obtaining marketing authorisation, allowing companies to apply simultaneously in multiple EU Member States without using the centralised procedure. The DCP relies on a scientific assessment by a Reference Member State (RMS) , which must then be recognised by the Concerned Member States (CMS) . DCP is commonly used for generic medicines and certain well-established products.

Decentralised Procedure for EU marketing authorisation

The Decentralised Procedure (DCP) is a European route for obtaining marketing authorisation, allowing companies to apply simultaneously in multiple EU Member States without using the centralised procedure.

The DCP relies on a scientific assessment by a Reference Member State (RMS), which must then be recognised by the Concerned Member States (CMS). DCP is commonly used for generic medicines and certain well-established products.