The Pharmacovigilance System Master File (PSMF) is now replacing the Detailed Description of the Pharmacovigilance System (DDPS), bringing veterinary medicinal products into closer alignment with requirements for human medicines. However, critical differences remain — and these have become key findings in recent inspections.
Here’s what you need to know:
- Unique PSMF Code: Assigned by the QPPV using the format PSMFXXXX-COUNTRY-MAH.
- Submission Process: The PSMF summary must be submitted as a VNRA Type C6 variation via the Union Product Database (UPD).
- Veterinary Support: If the QPPV lacks veterinary qualifications, an assistant veterinary surgeon is required.
- Database Mandates: Use Eudravigilance Veterinary and the Union Product Database — internal systems are not mandatory.
- QPPV Requirements: Proof of EV registration (as a UPD super user) is essential.
- Dose Factor: A transparent and well-documented calculation methodology is required.
Ensure your compliance strategy is robust and inspection-ready by addressing these evolving requirements.
Have a look at this informative flyer with the structure of the veterinary PSMF: PSMF Veterinary
Stay ahead of the curve — contact us to ensure your PSMF meets the latest regulatory standards. [email protected]
