PharmacovigilanceOfficial

EMA opens consultation on medically important VeDDRA terms list for veterinary pharmacovigilance

🇪🇺 EMA · Fri 13 Nov 2026

The draft guideline would replace the current appendix to the VGVP signal management module, with comments open until 31 January 2027 alongside a separate consultation on the module's revision.

The European Medicines Agency has opened a consultation on a draft guideline covering the list of medically important (MI) VeDDRA terms under the veterinary good pharmacovigilance practices (VGVP). The consultation runs from 13 November 2026 to 31 January 2027 (reference EMA/CVMP/PhVWP/220641/2026).

According to the Agency, the draft replaces Appendix 1 of the current VGVP Module: Signal Management (EMA/522332/2021), which sets out the medically important VeDDRA terms list. The change would turn the list into a guideline in its own right rather than an appendix to the signal management module.

The consultation sits alongside a wider revision of that module. A draft Revision 1 of the Signal Management guideline (EMA/522332/2021 Rev.1) is out for comment from 18 September to 18 December 2026. The Agency says it has been revised to reflect the current approach to signal management, covering scientific and quality aspects as well as the roles, responsibilities and procedures of the EU process for veterinary medicinal products.

The revision follows a concept paper (EMA/CVMP/PhVWP/31941/2026) that was open for comment from 13 February to 15 March 2026. It noted that the 2021 text anticipated future revisions and said the update would apply experience gained in implementing Regulation (EU) 2019/6 to signal management.

Comments on both drafts should be submitted using the Agency's template and sent to vet-guidelines@ema.europa.eu. The VGVP guideline has applied since 28 January 2022 to marketing-authorisation holders, the EMA and national authorities, covering centrally and nationally authorised veterinary medicines.

What it means for your team

  • Marketing-authorisation holders for veterinary products should review the draft MI VeDDRA terms list, as it is intended to replace the current Appendix 1 to the signal management module.
  • Two consultations are open at once: the Signal Management Revision 1 closes on 18 December 2026, and the MI terms list on 31 January 2027.
  • Teams should check internal signal management procedures against both drafts, since the final texts will replace the 2021 version that has applied since January 2022.
  • Comments go to vet-guidelines@ema.europa.eu on the Agency's template.

Official source: EMA ↗

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

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