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What is the Decentralised procedure? The decentralised procedure ( DCP ) is a European authorisation route resulting in a mutually recognised product ( MRP ). The difference between MRP and DCP is that a product must already be authorised in at least one Member State on a national basis in order for MRP to be used.
The purpose of this Regulation is to lay down Community procedures for the authorisation, supervision and pharmacovigilance of medicinal products for human and veterinary use, and to establish a European Medicines Agency (hereinafter referred to as the Agency).
EMA is governed by an independent Management Board. Its day-to-day operations are carried out by the EMA staff, overseen by EMAs Executive Director. EMA is a networking organisation whose activities involve thousands of experts from across Europe.
Centralised procedure [CP] This procedure results in a single marketing authorisation, granted by the European Commission, which allows a medicine to be marketed in all EEA (European Economic Area) countries (EU member states and the three EEA EFTA States: Iceland, Liechtenstein, and Norway).
Article 58 of the Regulation 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down the Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (EMA)1, allows the EMA to give a scientific

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It sets out procedures for authorising and supervising medicinal products for human and veterinary use and sets up the European Medicines Agency (EMA). The regulation introduces a centralised authorisation procedure for medicinal products in addition to existing national systems.
An application for a scientific opinion on the use of a human medicine intended exclusively for markets outside of the European Union. Medicines eligible for this procedure are used to prevent or treat diseases of major public health interest.
Article 58 of the Regulation 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down the Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (EMA)1, allows the EMA to give a scientific
The centralised procedure The European Medicines Agency is responsible for the scientific evaluation of applications for centralised marketing authorisations. Once granted by the European Commission, the centralised marketing authorisation is valid in all EU and EEA-EFTA states (Iceland, Liechtenstein and Norway).
EMAs policy on handling competing interests of scientific committee members and experts allows it to restrict or exclude the potential involvement of an expert in any Agency activity, due to interests in the pharmaceutical industry or in the medical-device industry.

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