EMA Marketing Authorization (MA) with conditions

Published by IRDiRC

Efficacy Data EMA Conditional Marketing Authorisation Marketing Authorisation Regulatory Affairs Safety Data

A marketing authorisation may be granted with certain conditions in order to ensure the collection of additional Safety and or efficacy data.

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The Innovation Management Toolbox was originally developed through funding from the EJP RD project, which received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825575. The continued development and maintenance of the Toolbox are now supported by the ERDERA partnership, funded under the European Union’s Horizon Europe Research & Innovation programme, grant agreement No. 101156595.

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EMA Marketing Authorization (MA) with conditions