PharmacovigilanceOfficial

EMA publishes draft veterinary PV guideline listing medically important VeDDRA terms

🇪🇺 EMA · Fri 13 Nov 2026

The European Medicines Agency has released a draft guideline on veterinary good pharmacovigilance practices (VGVP) covering a list of medically important VeDDRA terms.

The European Medicines Agency (EMA) published a draft guideline on veterinary good pharmacovigilance practices (VGVP) on 13 November 2026. The document is titled as covering the list of medically important (MI) VeDDRA terms.

The material available to VigiEye is limited to the title and a short summary. The full text was not available, so details such as the content of the list, how it is intended to be applied, and any consultation timetable cannot be confirmed here.

By way of context, VeDDRA is the Veterinary Dictionary for Drug Regulatory Activities, the standardised terminology used to code suspected adverse events reported for veterinary medicines. A guideline built around a list of medically important terms therefore touches on how such reports are classified and handled within veterinary pharmacovigilance.

What it means for your team

  • Veterinary pharmacovigilance teams should obtain the full draft from EMA and check what it means for their adverse event coding and processing.
  • Marketing authorisation holders for veterinary medicines may wish to check the draft for any consultation process and deadline for comments.
  • Details on scope, application and timing should be confirmed from the EMA document, as they are not established by the information currently available.

Official source: EMA ↗

Article written by VigiEye from the official source (EMA). AI-assisted; check the source before acting.

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