CRED Getting the CMC Dossier Right 2024

28/08/2024

European Regional Requirements

The Organisation for Professionals in Regulatory Affairs

37

Europe: Directive 2001/83/EC, Annex 1

• Unless there is appropriate justification, the maximum acceptable deviation in the active substance content of the finished product shall not exceed ± 5 % at the time of manufacture

The Organisation for Professionals in Regulatory Affairs

38

19