Marketing authorisation decentralised procedure

Marketing authorisations in the European community can be obtained at present by two main procedures - mutual recognition of a national authorisation from one Member State or a community-wide authorisation through a procedure known as the centralised procedure. In November 2005, a new procedure, known as the decentralised procedure, will be introduced under the new legislation. 

Where an applicant wishes to market a product in more than one Member State, an identical dossier will be sent to all relevant Member States. If an authorisation has not been previously granted, one Member State will be appointed by the applicant to act as RMS who will prepare a draft assessment report with a draft SPC and a draft of the labelling and package leaflet. The CMSs will have the opportunity to review and approve the documents. Therefore, conceptually, the decentralised procedure resembles the centralised procedure without the involvement of CHMP, representing consultation between the Member States before even the first marketing authorisation is granted. 

As a result of Council Regulation (EEC) No. 2309/93 of July 22, 1993, which established the European Agency for the Evaluation of Medicinal Products, three types of procedures for authorising the placing of medicinal products on the market were introduced, depending on the characteristics and specific nature of the medicinal product in question centralised procedure, decentralised procedure and national procedure. 

The Decentralised Procedure was introduced in 2001 as an attempt to streamline (and speed up ) the licensing process. The DCP may be used when a medicinal product has not received a marketing authorisation in any... 

National marketing authorisations were intended to be phased out from 1 January 1998. It was foreseen that beyond that date, all marketing authorisations within the European Union would have been issued under the rules governing medicinal products in the European Community through the Centralised Procedure, or the so-called Mutual Recognition or Decentralised Procedure (see below). However, national approvals for marketing have continued well beyond 1 January 1998. 

At the time of its inception, a procedure was laid down in Directive 75/318/EEC for a scheme for mutual recognition of marketing authorisations. This mutual recognition procedure , initially called the CPMP procedure , has had several other names attached to it, namely the multistate procedure and decentralised procedure . 

Regulation EEC/2309/93 also laid down Community procedures for the authorisation and supervision of medicinal products for human or veterinary use. It established two procedures for obtaining entry to the markets of the Member States, namely the multistate or decentralised or mutual recognition procedure and the centralised procedure . Figures 15.1 and... 

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