Quality: post approval change management protocols
HumanVeterinaryRegulatory and procedural guidanceQuality of medicinesResearch and developmentScientific guidelines
On Monday, 12 January 2026, between 07:00 and 10:00 CET (Amsterdam time), this website will be unavailable due to scheduled maintenance.
The European Medicines Agency's scientific guidelines on the post approval change management protocol help medicine developers prepare marketing authorisation applications for veterinary medicines
For a complete list of scientific guidelines currently open for consultation, see Public consultations
Questions and answers