Mutual Recognition Procedure, European

This is a new procedure introduced imder Directive 2004/27/EC. In contrast to the mutual recognition procedure, the decentrahsed procedure applies to products for which the centralised procedure is not mandatory and which are not authorised in any EU Member State. It facilitates the parallel submission to both RMS and CMSs, involvement of the CMS during the national evaluation phase, and parallel granting of national marketing authorisations after the positive finalisation of the European step of the procedure. Some of the finer details of this new procedure established under the new legislation are yet to be confirmed. 

As with the mutual recognition procedure, if no agreement can be reached during the 90-day European step, the matter is referred to the Coordination Group for resolution and if stUl unresolved, the CHMP will arbitrate and deliver an opinion. Consequently, the grounds for refusal... 

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],... 

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. 

MAs and variations thereto follow the requirements of the Europecm Directives in all respects. Assessment and legal procedures are carefully constructed to be in compliance with the European legislation and guidelines of the Committee for Proprietary Medicinal Products (CPMP). Data requirements and presentation format follow those laid down by Directives. Advice on planned applications can be sought from the MCA, and this is particularly recommended in the case of applicants planning to make use of the European Mutual Recognition Procedures. 

Under the mutual recognition procedure, the applicant company usually ends up receiving national marketing authorisations from some or all of the national drug regulatory authorities to whom the dossier is submitted. The centralised procedure, on the other hand, is all or none , and under it the applicant company would receive a single marketing approval from the EMEA valid in all European Union countries. Rejection of an application under the centralised procedure means that the product cannot be marketed in any Member State. 

Council Regulation (EEC) No. 2309/93 (see below) stands at the origin of the European Medicines (Evaluation) Agency (EMEA). Established in 1995, EMEA s main task is to coordinate the scientific evaluation of the safety, efficacy and quality of medicinal products which undergo either a Centralized (CP) or Mutual Recognition Procedure (MRP) for authorization. All scientific questions arising in these procedures are dealt with by the EMEA. (A detailed description of how these procedures work is given below). 

The European Medicines Agency (EMEA) is a decentralized body of the European Union created with the objective to harmonize regulatory activities in Europe. EMEA began its activities in 1995, when the European system for authorizing medicinal products was introduced, providing for a centralized and a mutual recognition procedure. Its main responsibility is the protection and promotion of public and animal health through the evaluation and supervision of medicines for human and veterinary use. 

The fact that more and more products are being included in the mandatory centralized procedure is indicative of a general reliance on this procedure more than on the mutual recognition procedure it can also reflect that not all national regulatory authorities have developed the same regulatory capabilities to authorize the marketing of new products for the whole European Community. 

Directive 2309/93 introduced further changes. It established a new body that is based in London, The European Medicines Evaluation Agency (EMEA), established January 1 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 28.1 and Figure 28.2, which show schematically the procedures which became operative on January 1 1995. 

Thus, as for the European Union, the requirements are based on accreditation, proficiency testing, the use of validated methods of analysis and, in addition, the formal requirement to use internal quality control procedures which comply with the Harmonised Guidelines. Although the EU and Codex Alimentarius Commission refer to different sets of accreditation standards, the ISO/IEC Guide 25 1990 and EN 45000 series of standards are similar in intent. It is only through these measures that international trade will be facilitated and the requirements to allow mutual recognition to be fulfilled will be achieved. 

In Europe, inspections are conducted by member states on behalf of the European Union. For drugs approved under the centralized procedure, inspections are coordinated by the European Medicines Agency (EMEA refer to Sections 7.3 and 8.3). For countries that are members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S see Section 7.13), there is mutual recognition of inspections performed by members. 

International agreements and regional cooperation e.g. GATT, European Acquis, specify the requirements for the free movement of goods and the elimination of technical barriers to trade, mutual recognition of test results and technical harmonization, in order to meet the needs of the market. The quality concept is being broadened to include additional aspects, tools and procedures. 

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