EMA consults on medically important VeDDRA terms to anchor veterinary signal management

What happened

On 13 November 2026 the European Medicines Agency opened a consultation on a draft guideline listing medically important VeDDRA terms for veterinary pharmacovigilance. The draft, published as part of the veterinary good pharmacovigilance practices (VGVP) framework, would replace the current appendix to the VGVP signal management module.

Comments are open until 31 January 2027. A separate consultation on the revision of the signal management module itself runs to the same deadline. The two documents are therefore meant to be read together: one sets out how signals are managed, the other would define a key list that supports that process.

The records available to us do not describe which terms are on the draft list, how many there are, or how the list is intended to be applied in practice. Those details are in the draft itself, and we have not summarised them here.

Why a list of terms matters

VeDDRA is the standardised terminology used to code clinical signs and adverse events in animals. Coding is only the first step. Teams also need a shared view of which coded events deserve closer attention when they review safety data.

A defined list of medically important terms gives marketing authorisation holders (MAHs) and regulators a common reference. Moving it from an appendix into a standalone draft guideline suggests it is being treated as a distinct, consultable piece of guidance. That matters for anyone whose signal detection, triage or review procedures reference the existing appendix.

Whether the new list changes the content of the old appendix, or mainly its status and format, cannot be told from the records. PV teams should compare the draft against their current internal references rather than assume continuity.

The signal management context

The consultation lands alongside recent activity on EMA's veterinary signal management page, which sets out MAH duties and revised templates. The page also covers a closed targeted review of phenobarbital products. That review recommended product information changes for dogs.

On the same day, the PRAC released final EU-language translations of the phenobarbital product information text, linked to a targeted signal management procedure. Taken together, these items show the veterinary signal process working end to end: a signal is reviewed, product information changes are recommended, and translated texts are finalised for implementation.

The phenobarbital case is not linked to the medically important terms list in the records, and we should not imply a causal connection. It is useful as a reminder of what the signal management module governs in practice. Changes to the module and its supporting list will shape how future signals are identified and handled.

Who is affected

The most directly affected are MAHs of veterinary medicines in the EU and their pharmacovigilance staff. These teams run signal detection, document reviews and follow EMA templates. Any change to the reference list for medically important terms can flow into SOPs, database configuration and review criteria.

Regulatory affairs colleagues handling product information updates should also pay attention. Signal outcomes such as the phenobarbital recommendations end up as label changes. Contract PV providers serving animal health clients will need to know early whether their procedures need amending.

Outside the veterinary field, human-medicine PV teams are not directly in scope. The draft concerns veterinary PV only.

What to watch

The first date to note is 31 January 2027, when both consultations close. Because the list and the module are being consulted on in parallel, the most useful comments will probably address how the two fit together. Examples are whether the list's role is clearly defined in the revised module, and whether the transition from the old appendix is workable.

After the consultation, EMA will review comments and finalise the texts. The records do not give a timetable for finalisation or an implementation date, so those remain unknown. Teams should avoid hard-coding changes into systems until the final versions are published.

It would also be sensible to check whether any current signal-related templates need updating in light of the revised MAH templates already published on the signal management page.