Decentralised Procedure

The decentralised procedure can be used in cases where the product has never been authorised in any of the Member States, and the applicant wishes to obtain a license in a number of states simultaneously. The applicant must submit applications with the complete dossier to the Competent Authorities of each of the Member States where authorisation is desired. A single Member State should be chosen as the reference state to undertake the scientific assessment ofthe complete dossier, while the other states are designated as concerned states. The review process has many parallels vhth the centralised procedure, in that similar time lines exist, the reference State plays the role ofthe rapporteur, and the concerned States replace the CHMP. Once all States have validated that the dossiers are complete, the reference State is allowed 70 days to review the dossier and prepare a preliminary assessment report, which is circulated to the concerned Member States and the applicant. Comments from the concerned Member States and applicant responses are collected so that by day 120 the reference State may issue a draft assessment report together vhth draft SPC, label and leaflet texts. The clock may be stopped until requested responses from the applicant are received. The application then enters the second step in the assessment process, during which all the concerned Member States consider the 

Rapporteurs appointed (CHMP) Dossier Submitted (Applicant) 

I Scientific Review (Rapporteurs) Preliminary Assessment Reports (Rapporteurs) ----------------  

List of questions issued to applicant (CHMP/EMEA)----------  

Response revised SPC and labelling submitted (Applicant) Sample testing 

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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. 

Applications through mutual recognition or decentralised procedure are submitted to national authorities. The applications for community... 

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. 

The mutual recognition (or decentralised) procedure allows applicants to nominate one... 

The decentralised procedure is the most difficult of the three registration strategies to understand (See Figure 4). The procedure is based on the concept that the MS of the EU together constitute a single market. An MA issued after evaluation by the competent authority of one MS should be valid in the other MS. In other words, different standards should not apply in different parts of the market this gives rise to the concept of Mutual Recognition. 

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. 

Centralised and decentralised procedures are set out and governed by Community legislation, while the Member States are charged with defining the rules of national procedures. 

In line with Article 14 of Decree-Law No. 72/91 of February 8, as amended by Decree-Law No. 272/ 95 of October 23 the rules applying to variations to the terms of MAs of medicinal products authorised under the national procedure are hereby set out. This is made in agreement and harmony with the Community rules governing the same variations under the decentralised 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... 

The mutual recognition procedure (or the decentralised procedure ), which is in essence a national registration recognised by the other member states. 

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 . 

Have the centralised and decentralised procedures contributed in a qualitative and quantitative sense to the creation of a harmonised Community market in medicinal products ... 

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