Hybrid or Mixed Marketing Authorization Application in the EU: not a trivial decision in new development programs for established drugs

Published on: Feb 20, 2012

For any medicinal product Marketing Authorization Application (MAA) in the European Union, the applicant needs to indicate the legal basis for the application. This legal basis, laid down in Directive 2001/83/EC as amended, determines the dossier content, the market exclusivity, and the pediatric requirements in a significant way.

Andreas Vogel
Hybrid or Mixed Marketing Authorization Application in the EU: not a trivial decision in new development programs for established drugs

2012 – Drug Information Journal

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Hybrid or Mixed Marketing Authorization Application in the EU: not a trivial decision in new development programs for established drugs

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