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.
|Translated title of the contribution||Drug product registration and marketing authorization procedures in EU-A perspective|
|Number of pages||6|
|Journal||Marmara Pharmaceutical Journal|
|Publication status||Published - 2013|
All Science Journal Classification (ASJC) codes
- Pharmacology, Toxicology and Pharmaceutics(all)
- Pharmacology (medical)