Module 3 Presentations

07/05/2024

Which data is required in the Dossier?

The Organisation for Professionals in Regulatory Affairs

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Which data is required in the Dossier?

3.2.1.7. Stability of the active substance(s ) a) The types of studies conducted, protocols used, and the results of the studies shall be summarised b) Detailed results of the stability studies, including information on the analytical procedures used to generate the data and validation of these procedures shall be presented in an appropriate format c) The post authorisation stability protocol and stability commitment shall be provided

(Annex 1 to Directive 2001/83/EC amended)

The Organisation for Professionals in Regulatory Affairs

50