Review on: Dossier submission in the European countries by using mutual recognition procedure and decentralized procedure

Abstract

There is different procedure used to submit drug product for marketing authorization process. Mutual recognition procedure (MRP) is one of them. The European commission had published the procedure in consultation with competent authorities of member state. Using MRP, the applicant can apply for marketing authorization in one or more European Union nations. (MAH) who already holds authorization for a medical product in a EUROPEAN UNION (EU) member state can use the mutual recognition method to get authorization in additional EU member states. Directive 2004/27/EC established the decentralized procedure. Because the mutual recognition mechanism is also reliant on national authorities recognizing a first assessment done by one-member state, the distinction is that it only applies to pharmaceutical products that do not yet have a marketing authorization at the time of application.