Decentralized procedure

Decentralized Procedure This is applicable where authorization has not yet been approved in any member state. The applicant may apply for simultaneous authorization in more than one ELI member state for medicines that do not fall within the mandatory scope of the centralized procedure. 

The decentralized procedure is made on the basis of mutual recognition. Council Directive 93/39/EEC [8] has been implemented in all member states in accordance... 

Even when Community MRLs have been established, similar products in various member states may differ greatly with respect to the withdrawal times established by national authorities. Most member states employ a simple method by which the withdrawal time is set at the time when residues in all tissues in all the animals have depleted to below the respective MRL values. In addition, some member states then add an additional safety period if, for example, there are large variations in the depletion data set or other shortcomings are found in the studies. On the other hand, some other member states use statistical methods to establish withdrawal times. A greater degree of harmonization would be possible if a standard approach for calculating the withdrawal time was adopted throughout the European Union. Moreover, this would aid both the centralized and the decentralized procedures. 

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],... 

Decentralized Procedure (DCP) The decentralized procedure was established as an application route in late 2005. This procedure is essentially a combination of the national and the mutual recognition procedures. The applicant chooses a reference member state to undertake the initial assessment. On completion of the RMS assessment, the concerned member states can put forward additional questions to those raised by the reference member state. If the questions are answered by the applicant to the satisfaction of the reference member state and concerned member states, the drug can be authorized. The benefit of the decentralized procedure is that all concerned member states are provided with the application dossier from the start of the procedure. 

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. 

Simultaneously, Directive 93/39/EEC amended Directives 65/65/EEC, 75/318/EEC,Pl and 75/319/ EEC and established the Decentralized Procedure (commonly known as the Mutual Recognition Procedure). 

The Decentralized Procedure is made on the basis of mutual recognition. Council Directive 93/39/EEC has been implemented in all member states in accordance with Directives 65/65/EEC and 75/319/ EEC. The sponsor makes a submission to the national health authority of one member state, with a request to assess the dossier for mutual recognition. Within 210 days, the so-called Reference Member State (RMS) must approve the application, prepare an assessment report, and agree on an SPC. The clock may be stopped to obtain further information during this time. 

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). 

This mutual recognition procedure , initially called the CPMP procedure , has had several other names attached to it, for example the multistate procedure and the decentralized procedure . Manufacturers could choose the country that they would wish to be the initiating or reference country to forward their dossier into the multistate procedure. Some countries were more popular than others (see Table 33.4). 

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

The new Directive (2004/27) introduces a distinction between the MRP and the decentralized procedure. The decentralized procedure allows the... 

The MRP can be used for both full-length and abridged applications. Variations to an authorization obtained through the MRP or the decentralized procedure follow the same regulatory pathway. The MRP cannot be used for products that have received a negative opinion or have been withdrawn from the CP (see below), except by submitting a completely new dossier. 

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). 

At the beginning, the EMEA set up two procedures for product authorization in Europe, the centralized and decentralized procedures. 

The decentralized procedure establishes a mutual recognition between Member States. Briefly, this procedure is based on ... 

The mutual recognition procedure (or the decentralized procedure ), which is in essence a national registration recognized by the other Member States. 

---