FREE WEBINAR | Veterinary Pharmacovigilance – New Regulation from 28 January 2022

FREE WEBINAR | Veterinary Pharmacovigilance – New Regulation from 28 January 2022

When? 📆 27th of January 🕛 3:00- 4:00 p.m. (CET)

The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) will modernise the existing rules on the authorisation and use of veterinary medicines in the European Union (EU) when it becomes applicable on 28 January 2022. It contains new measures for increasing the availability and safety of veterinary medicines and enhances EU action against antimicrobial resistance.

Join Asphalion expert Laura Eder in this webinar where she will address the newest updates on the veterinary medicinal products regulation:

1. Veterinary pharmacovigilance – definition and legal basis

  • New Regulation (Regulation (EU) 2019/06) – What is new?
  • PV responsibilities of the MAH – Regulation (EU) 2019/06

2. Collection, recording and reporting of suspected adverse events for veterinary medicinal products

  • Who can be affected?  & What do we have to report? –  Important topic to highlight due to the new EU Regulation
  • Union Product Database (UPD)
  • Eudravigilance Veterinary (EVVet) – Reporting timelines & Electronic reporting of Adverse events
  • VeDDRA

3. Signal Management

  • New Regulation (Regulation (EU) 2019/06) – What is new?
  • Signal management process: overall approach, medically important terms, signal prioritization, frequency of monitoring & due dates for signal management

4. Pharmacovigilance system master file (PSMF)

  • General considerations- Regulation (EU) 2019/06 – What is new?
  • Content of the main part and the annexes

5. Collection of Sales and Use data

  • Volume of sales & Union Product Database (UPD)
  • Collection of Antimicrobials Sales and Use data

🔗 Registrations are open. You can register HERE.


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