Concerned member states

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... 

Identical applications are submitted to those member states where marketing authorizations are sought. The first member state that reviews the application is called the Reference Member State. It notifies other states, called Concerned Member States. Concerned Member States may suspend their own evaluations to await assessment by the Reference Member State. The decision of the Reference Member State is forwarded to the Concerned Member States. If the Concerned Member States reject mutual recognition, the matter is referred to the CHMP of the EMEA for arbitration. The EMEA forwards its opinion to the European Commission, which makes the final deci-... 

The mutual recognition submission can then be made to any number of the other member states and the RMS sends a copy of the assessment report to the concerned member states (CMS). Within 90 days, member states must raise serious objections, and if there are none, each CMS issues a national marketing authorization with an... 

Deficiencies in the development of the above-mentioned datasets and in the implementation of measures might be due to administrative and/or financial deficiencies, especially in the course of the economic crisis in recent years. Possible ways to overcome these hurdles depend on the specific situation in the concerned Member States. Suitable approaches might be to encourage transnational projects so as to exchange best practice examples and to support institution building such as projects under the South East Europe Transnational Cooperation Programme,18 the Central... 

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. 

Sponsors initially submit their dossiers to a single MS. That MS conducts the initial review, and is termed the reference member state (RMS). When sponsors then request mutual recognition by other MS, the latter are termed concerned member states (CMS). The RMS is selected by the sponsor. 

Figure 34.3 Mutual recognition procedure (MRP) member state (MS), concerned member states (CMS)...

EU countries, which is designed as the reference member state (RMS). Once the RMS approves the product, it will then send an assessment report to other EU member countries the company desires to market the product. The other EU countries are called the concerned member states (CMSs). They will approve the product if they concur with the assessment of the RMS. The CMS can disagree with the assessment of the RMS based on safety concerns. The company and the dissent- ing CMS will go into arbitration. Oftentimes, the many objections are political in nature, making the MRP a rather protract and chaotic process. Because the company cannot launch the product in any CMSs unless the arbitration is resolved, they will generally withdraw... 

During this procedure, the original national authority and the applicant act jointly. The applicant submits an application and the updated dossier to each Member State where the applicant seeks an approval. The original national authority (now called the Reference Member State, RMS) transmits its original assessment report (updated if necessary) to these Member States (now called the Concerned Member States, CMS), together with the Summary of Product Characteristics (SPC) approved by it. 

There is no true mutual recognition Concerned Member States continue to assess applications. The concept of risk to public health is currently being used as a mechanism for raising matters that the... 

EU concerned member states, which involves a defined 90-day review period. Timing for comments/questions, company responses, discussions, and final action are well defined and quite aggressive. Under MRP, responses to all issues raised by the EU member states must be submitted within 7 days of receipt of the questions, which occurs approximately 2 months following initiation of the process. The final decision on the application (approval, company withdrawal of the application in some or all member states, or binding arbitration) is then made by day 90. 

Under the current mutual recognition and centralized procedures, variations must be reviewed with, and approved by all concerned member states. The variation is provided under mutual recognition through the reference member state for the original application, and defined timelines exist for review and approval of the variation, based on whether it is a Type I or II submission. The timelines do not include the time required by the application holder to respond to any questions raised by any of the concerned member states. 

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