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

Kekare, Ashish and Jagadish, PC and Janodia, Manthan D and Bhat, Krishnamurthy and Udupa, N (2013) Drug product registration and marketing authorization procedures in EU-A perspective. Marmara Pharmaceutical Journal, 17. pp. 1-6.

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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.

Item Type: Article
Uncontrolled Keywords: European Economic Area, marketing authorization.
Subjects: Pharmacy > MCOPS Manipal > Pharmaceutical Quality Assurance
Pharmacy > MCOPS Manipal > Pharmacy Management
Depositing User: KMC Manipal
Date Deposited: 14 Jan 2013 05:14
Last Modified: 14 Jan 2013 05:14
URI: http://eprints.manipal.edu/id/eprint/77971

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