Inspection et autorisation

Federal Agency for Medicines and Health Products (FAMHP) Version 2 imported change current

Imported from official source

From 7 August 2027, SoHO entities will be required to comply with Regulation (EU) 2024/1938 and complete the procedures applicable to their category. Prepare a Preparation Process Dossier (PPD), where applicable; Implement a quality management system and appoint a responsible person; Prepare a SoHO Establishment Dossier (SED); Prepare a Preparation Process Dossier (PPD), where applicable. …

This version

Version: 2 of 2
Recorded: October 14, 2026 11:32
Change: Imported change
Content hash: 0ec90a8ae3e42a0851a8d99fede57d48
All versions: Revision history