Marketing Authorization Procedure and Their Requirements for Pharmaceutical Products in European Union

Abstract

Developing a new drug requires a great amount of research works in chemistry, manufacturing, controls, preclinical science and clinical trials. European Union (EU) is a hub of political and economic union of 28 member states (MS) and extensive amount of effort was spent by the EU Commission, the EU parliament, the European Medicines Agency (EMEA) and the national authorities in updating the EU regulatory environment for pharmaceuticals and granting marketing authorizations within the EU region. There are mainly three procedures by which a marketing authorization of pharmaceutical product in EU can be granted. Like 1. Centralized Procedure which is compulsory for any novel medicinal products and the subject to agreement by Committee on Proprietary Medicinal Products (CPMP), 2. Mutual Recognition Procedure (MRP) which commences only after a marketing authorization has been issued in any member state of EU, which then becomes the Reference Member State (RMS) and 3. Decentralized Procedure which came into force with the newly revised EU pharmaceutical Directive in November 2005 which is applicable in cases where an authorization does not yet exist in any of the EU Member States. However, Every EU country has their own registration process, which can be used by them when manufacturer wish to register their product in respective countries. However, if the European directive is completely implemented, the harmonization process appears difficult in consideration of the different social, political and economical characteristics of the different countries. Hence, the Main objective of this work is to understand the pharmaceutical product registration by different marketing procedures in European Union.

Keywords: European Union, National procedure, Centralized Procedure, Mutual Recognition Procedure, Decentralized Procedure