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European Procedures for Marketing Authorisation (MA)

Within the European Union there are different Marketing Authorisation (MA) procedures an applicant may choose, to receive a marketing authorisation (MA) which is valid in more than one Member State ( unlike the so-called “national” procedure).

• A Centralised Procedure (CP) results in a MA in all EU/EEA Member States.

• The applicant has to initiate a so-called “Decentralised Procedure” (DCP) or apply for a “Mutual Recognition Procedure” (MRP), if he wishes to obtain a national MA for the same medicinal product in more than one EU/EEA Member State.

The Centralised Procedure (CP) has been established in the Community since 1995. Whereas in the beginning entrance requirements were set very narrowly, they were later extended in the course of the revision of the European pharmaceutical legislation. Among other reasons this was done with the objective of rendering the procedure more appealing for applicants and to contribute to the harmonisation of the European market. Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31^st March 2004 constitutes the legal basis for “the agreement to create centralised procedures for the authorisation and supervision of human and veterinary use and establishing a European Medicines Agency (EMA).”

With the adoption of Directive 2001/83/EC of the European Parliament and of the Council of 6^th November 2001, the Decentralised Procedure (DCP) was established, which allows the simultaneous application for a MA in more than one Member State.

If a national MA already exists in one Member State and the medicinal product is to be authorised in other Member States as well, the applicant has to choose the Mutual Recognition Procedure (MRP). This procedure was introduced by Directive 75/319/EEC (later codified in Directive 2001/83/EC ) as a means to give the same medicinal product access to more than one Member State in a harmonised procedure. The MRP is only applicable to those products, which do not fall within the mandatory scope of the CP.