Editor-in-Chief Hatice Kübra Elçioğlu Vice Editors Levent Kabasakal Esra Tatar Online ISSN 2630-6344 Publisher Marmara University Frequency Bimonthly (Six issues / year) Abbreviation J.Res.Pharm. Former Name Marmara Pharmaceutical Journal
Marmara Pharmaceutical Journal 2013 , Vol 17 , Issue 1
Drug product registration and marketing authorization procedures in EU-A perspective
Ashish Kekare2, Jagadish PC3, Manthan Janodia1, Krishnamurthy Bhat3, Swati Karande4, N Udupa1
1Manipal College of Pharmaceutical Sciences, Department of Pharmacy Management, Manipal, Karnataka, India
2Manipal University, Department of Advanced Pharmaceutical Studies, Manipal, Karnataka, India
3Manipal College of Pharmaceutical Sciences, Department of Pharmaceutical Quality Assurance, Manipal, Karnataka, India
4Bioplus Pharma, Regulatory Affairs, Bangalore, India
DOI : 10.12991/201317384 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. Keywords : European Economic Area, marketing authorization
Marmara University