Kekare, Ashish Manipal University - Department of Advanced Pharmaceutical Studies, India , Jagadish, PC Manipal College of Pharmaceutical Sciences - Department of Pharmaceutical Quality Assurance, India , Janodia, Manthan Manipal College of Pharmaceutical Sciences - Department of Pharmacy Management, India , Bhat, Krishnamurthy Manipal College of Pharmaceutical Sciences - Department of Pharmaceutical Quality Assurance, India , Karande, Swati Bioplus Pharma - Regulatory Affairs, India , Udupa, N Manipal College of Pharmaceutical Sciences - Department of Pharmacy Management, India

Drug product registration and marketing authorization procedures in EU-A perspective

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There are 27 European Union (EU) member states, 3 European Economic Area (EEA) and European Free Trade Association (EFTA) states. For a company willing to market the medicinal product in to the EEA, marketing authorization (MA) for the respective product must be issued by competent authority of member state or authorization granted according to Regulation (EC) No. 726/2004 for entire community. Europe constitutes large population and European government is alert regarding safety of the public in EU. There are changes in the procedures for the marketing authorization by the EU. Different types of procedures for the application of marketing authorization are available in the EU and these procedures are discussed here.

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European Economic Area , marketing authorization

Journal of Research in Pharmacy

6