European Union Decentralised Procedure is a regulatory procedure within the EU for the authorisation of certain human and veterinary medicinal products. The procedure involves assessment and a recommendation from a single EU Member State (reference member state), which is then forwarded to the European Commission for a final decision that is binding on all EU countries (national marketing authorisation to european marketing authorisation).
The advantages of this procedure are that it streamlined and more efficient than the previous mutual recognition procedure, and that it allows for early EU-wide marketing authorization of certain medicinal products.
It should be noted that the EU DCP is not applicable to all medicinal products, and that the procedure is voluntary for both Member States and companies.
The EU Decentralised Procedure (DCP) is a regulatory pathway for the authorization of certain human and veterinary medicinal products in the European Union (EU). The DCP replaces the former Mutual Recognition Procedure (MRP), and was introduced in order to streamline EU-wide authorization of medicinal products and make the process more efficient. The DCP is voluntary for both EU Member States and companies, and is not applicable to all medicinal products.
The advantages of the EU DCP include early EU-wide marketing authorization of certain medicinal products, as well as a more flexible and effective tool for the regulation of medicinal products than the centralised procedure.
The EU DCP is therefore considered to be a more efficient and advantageous pathway for the authorization of medicinal products in the EU.