Decentralized procedure , marketing

Four routes are available for obtaining a marketing authorization (MA) for a human medicinal product in the European Economic Area independent national procedure, mutual recognition procedure (MRP), decentralized procedure (DCP), and centralized procedure (CP) [5-7],... 

The decentralized procedure, applying to a majority of conventional medicinal products, is based on the principle of mutual recognition of national authorizations. It provides for the extension of a marketing authorization granted by one member state to one or more other member states identified by the applicant. 

National MAs were intended to be phased out after 1 January 1998, but it is likely that national approvals for marketing will continue beyond that date. The future foresees that all MAs within the European Union (EU) will have been issued under the rules governing medicinal products in the EC by virtue of the centralized procedure or the so-called mutual recognition or decentralized procedure (vide infra). 

Application for marketing approval, using either the centralized or decentralized procedure, has to be accompanied by three expert reports, which... 

Choice between centralized and decentralized procedures in the case of many NCEs (those for which the centralized procedure is not mandatory) involves many factors, and the decision is a strategic milestone involving medical practice, manufacturing plans, the nature of product, market forces, and the size, resources, and strengths of the sponsor in the EU (see Harman, 2004, for more details). 

Under the centralized procedure, applications are accepted with regard to (a) products of biotechnology (b) NCEs (drugs in which the active ingredient is new). Biotech products are grouped as list A and NCEs as list B . Marketing approval application for biotech products must be considered under the centralized procedure, whereas NCEs can be considered under centralized or decentralized mechanisms. 

Centralized (and to a lesser extent decentralized) authorization procedures administration of these procedures to achieve a single evaluation and marketing authorization for medicinal products... 

There are two European procedures for obtaining a marketing authorization in more than one country belonging to the EU. These are the Centralized Procedure and the Decentralized or Mutual Recognition Procedure. 

Directive 2309/93 introduced further changes. It established a new body that is based in London, established on 1 January 1994, and two procedures for the obtaining entry to the markets of the member states, namely the multistate or decentralized or mutual recognition procedure and the centralized procedure see Figures 33.1 and 33.2, which show schematically the procedures which became operative on 1 January 1995. 

In the EU, marketing authorizations may be granted either by EMA (centralized procedure) or national authorities (decentralized and mutual recognition procedures), but MRLs are set by EU. 

Table 28.7 shows the use of the decentralized or multistate or mutual recognition procedure during 1997. In this procedure the initial or reference member state that granted marketing approval forwards the necessary documents for registration... 

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