Marketing authorization application mutual recognition procedure

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. 

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. 

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. 

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 In many ways, the National Authorization system is superseded by the Centralized and Mutual Recognition Procedures.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 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. 

A MRP, which is appHcable to the majority of conventional medicinal products. AppHcations are made to the Member States selected by the appHcant and the procedure operates by mutual recognition of national marketing authorizations. Where this is not possible, the EMEA is called upon to prepare a binding arbitration. There is also a decentrahsed procedure (DP) similar to MRP, that is also not applicable for Biotech products. 

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