EMA drafts new list of medically important VeDDRA terms for veterinary pharmacovigilance

What happened

On 13 November 2026 the European Medicines Agency published a draft guideline under the veterinary good pharmacovigilance practices (VGVP) framework. It covers a list of medically important terms from VeDDRA, the standardised terminology used to code adverse events in animals.

According to EMA's VGVP page, the draft would replace the current appendix to the VGVP signal management module. Comments are open until 31 January 2027. A separate consultation on a revision of the signal management module itself runs in parallel, so the two documents are being reviewed together.

The records give us the document's title, its position in the VGVP structure and the consultation deadline. They do not say how many terms are on the list, which terms are added or removed, or how the list will be applied in practice. Those details sit in the draft PDF, and teams should read it rather than rely on summaries.

Why it matters for signal management

A list of medically important terms is a working tool. It sits in an appendix to the signal management module, so it belongs to the part of the VGVP framework that deals with detecting and handling safety signals. Changes to it can affect how marketing authorisation holders (MAHs) screen and prioritise their veterinary adverse event data.

Because the draft replaces the existing appendix and does not simply add to it, MAHs should do a gap analysis. They should compare the new list with the one their procedures currently reference. They should also check whether the standard operating procedures, signal detection queries and training materials that cite the old appendix would need to change.

The parallel consultation on the module's revision is just as important. A term list only makes sense within the procedures that use it. Reading the draft appendix and the revised module side by side is the only reliable way to judge the operational impact.

A live example: phenobarbital

The same day, EMA's PRAC published final EU-language translations of the product information text for phenobarbital, linked to a targeted signal management procedure. EMA's veterinary signal management page describes that targeted review as closed. It says the review recommended product information changes for dogs.

The phenobarbital case is not connected in the records to the new term list, and we should not imply it is. It does show the signal management system working in the veterinary sector, from a targeted review to recommended label changes to translated product information.

The same EMA page sets out MAH duties and revised templates. Teams reviewing the draft guideline should check that page too, so the consultation comments reflect current expectations on MAH responsibilities and documentation.

Who is affected

The most directly affected are the veterinary pharmacovigilance teams and QPPV-equivalent responsible persons at MAHs, and anyone maintaining signal detection and triage procedures that refer to the current appendix.

Service providers and safety database vendors may also be affected. The records do not describe any coding or IT impact. If the final list differs materially from the current appendix, organisations that configure adverse event coding or reporting tools around it would need to assess the effect once the final text is known.

Veterinary professionals and animal owners are not addressed in the records, so we can say nothing about changes to reporting behaviour on their side.

What to watch

The first date to note is 31 January 2027, when both consultations close. Several things are not yet known: when the guideline will be finalised, whether it will change after comments, and what transition period MAHs will get to align their procedures. None of this appears in the records.

Teams should watch for the final guideline and the revised signal management module together. They should also watch for further targeted signal procedures that follow the phenobarbital pattern, because these will show in practice how EMA expects MAHs to handle veterinary signals.

For now the sensible course is to read the draft, test it against current procedures and decide whether to comment. Comments from industry on practicality are most useful while a draft is open.