Marketing authorization mutual recognition

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. 

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. 

A further 30 days is set aside in which any difficulties that arise may be resolved. The total application duration is 300 days. If one or more states refuse to grant the marketing authorization (i.e. mutual recognition breaks down), then the difficulties are referred back to the EMEA. The CPMP will then make a decision ( opinion ), which is sent to the European Commission. The Commission, taking into account the CPMP opinion, will make a final decision that is a binding. 

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. 

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... 

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. 

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.)... 

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. 

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. 

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. 

Commission Regulation (EC) No 1084/2003 of 3 June 2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a member state (mutual recognition variations). 

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. 

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