Mutual Recognition Procedure , marketing

The first of these can be used when a product is to be marketed in a single country. It can be used for any type of application except for certain types of biotechnology-based items. Having been approved in one country, in most cases an application to a second country will trigger the Mutual Recognition procedure in other concerned countries. There are certain exceptions to this, e.g., where a product has different summaries of product characteristics (SmPCs) in different countries, and these have not been subjected to a harmonization procedure. Line extensions to such products could also remain subject to national procedures. 

The mutual recognition procedure is an alternative means by which a marketing authorization may be sought. It is open to all drug types except products of biotechnology. Briefly, if this procedure is adopted by a sponsor, then the sponsor applies for a marketing licence not to the EMEA, but to a specific national regulatory authority (chosen by the sponsor). The national authority then has 210 days to assess the application. 

Mutual Recognition Procedure The Mutual Recognition Procedure is stated in Council Directive 93/39/EEC. In essence, once a drug is approved for marketing authorization by one member state, the company concerned can apply for marketing authorization in other member states through the mutual recognition procedure in place since 1998. 

Similarly, where there are public health concerns as a result of pharmacovigilance data, nationally authorized products or products authorized by the mutual recognition procedure may be referred rmder Articles 12 or 15 of Directive 75/319/EEC. The CPMP/CVMP gives an opinion on variation, suspension, or withdrawal of the marketing authorization in such cases. 

Conceptually, this procedure for Community authorisations (also known as the centralised procedure) resembles a hybrid of the national procedure and the mutual recognition procedure, with the differences that first, the application is submitted to EMEA second, the dossier supporting the application undergoes a detailed assessment by the CHMP before approval in any Member State of the EU third, the applicant is provided with an opportunity to clarify any issues raised by any of the EU Member States fourth, the procedure naturally has an extended time frame but stUl with predetermined deadlines and finally, the applicant ends up with an approval or a refusal to market the product in all or any Member States of the EU. The centralised procedure is shown in Figure 17.2. 

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. 

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],... 

Mutual Recognition Procedure (MRP) This procedure begins with a national application to one member state (MS), and when a marketing... 

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. 

Under the mutual recognition procedure, the applicant company would receive a number of national MAs from national drug regulatory authorities. Under the centralized procedure, the applicant company would receive a single marketing approval from the EMEA, valid in all EU countries. 

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 . 

This directive required that products covered by Annex A of the classification had to be referred to the CPMP for an opinion before a marketing authorisation (MA) could be granted in any Member State. This process became known as the Concertation Procedure, or Centralised Procedure. Products covered by Annex B could, at the request of the manufacturer, be dealt with by the Concertation Procedure or by an individual national authority and then achieve entry into other EU Member States markets if requested by means of the multistate or mutual recognition procedure. 

Regulation EEC/2309/93 also laid down Community procedures for the authorisation and supervision of medicinal products for human or veterinary use. It established two procedures for obtaining entry to the markets of the Member States, namely the multistate or decentralised or mutual recognition procedure and the centralised procedure . Figures 15.1 and... 

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. 

Application for marketing authorisation using either the centralised or the mutual recognition procedure has to be submitted in four highly structured parts - I, II, III and IV. Volume 2B of the Rules Governing Medicinal Products gives a detailed breakdown of the structure of each part of the dossier, including the three mandatory expert reports. 

The first of these guidelines lays down the roles and responsibilities of the marketing authorisation holders and of the national competent authorities in respect of the products authorised through the national procedures (including mutual recognition procedure). Also defined are the roles and responsibilities of the Reference Member States (for mutual recognition products) and of the rapporteur and EMEA for centrally approved products. 

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