Mutual recognition procedure marketing authorization

At this time a procedure was laid down in Directive 75/318, a scheme for mutual recognition of marketing authorizations. Article 9 of this Directive envisaged that ... 

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. 

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],... 

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. 

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. 

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. 

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. 

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. 

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. 

National Authorization Procedure To obtain marketing authorization in a country, the application must be submitted to the Competent Authority of that Member State in its own language. For National Authorizations in more than one country, submissions have to be sent to each country in its own language. In many ways, the National Authorization system is superseded by the Centralized and Mutual Recognition Procedures. 

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. 

In the EU, marketing authorizations may be granted either by EMA (centralized procedure) or national authorities (decentralized and mutual recognition procedures), but MRLs are set by EU. 

There are three procedures by which pharmaceutical products may gain a marketing authorization in the EEA. These are the National, Mutual Recognition, and Centralized procedures. 

Until only a few years ago, a company intending to market a new drug product in the EU would submit a national NDA in each country in which authorization was sought. While national procedures may still be used in limited situations, such as for approval of product line extensions, a firm must choose the mutual recognition or centralized system. (We will not discuss the approval process for generic products.)... 

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. 

Establish a pool of multinational scientific expertise (by mobilizing existing national resources) in order to achieve a single evaluation via the centralized or mutual recognition marketing authorization procedures. 

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