PharmacovigilanceOfficial

EMA page on veterinary signal management details phenobarbital review and updated MAH templates

🇪🇺 EMA · PRAC · Fri 13 Nov 2026

EMA's veterinary signal management page sets out marketing authorisation holder duties, revised templates and the closed targeted review of phenobarbital products, which recommended product information changes for dogs.

EMA has updated its veterinary signal management page, which sets out how the Agency, national authorities and marketing authorisation holders (MAHs) detect and manage safety signals for veterinary medicines on the EU market. The legal basis is Article 81 of Regulation (EU) 2019/6. MAHs must continuously monitor EudraVigilance Veterinary and tell EMA and national competent authorities about validated signals.

The page points MAHs to a revised veterinary signal assessment report template (EMA/464566/2021 Rev.2, last updated 4 December 2025). EMA says the revision gives more detailed guidance on what to submit and aims for consistency across all types of validated signals. Changes include a standardised overview of signals, such as linked VeDDRA terms and whether a submission is initial or follow-up, fuller guidance for each section, reference to mandatory analysis dates and EVV queries, and standardised outcome statements in the conclusion. EMA says the template should be used alongside the updated Veterinary Union Pharmacovigilance Database Best Practice Guide, which now covers signal management through the IRIS platform and the EudraVigilance Veterinary Data Warehouse.

MAHs should also report the outcomes of their signal management annually through IRIS. The recommended due-date spreadsheet (EMA/546918/2023-Rev.3) was last updated on 5 June 2026.

The page also lists targeted signal management procedures, which EMA or national authorities can start at any time under Article 81(3). The phenobarbital procedure (ATCvet code QN03AA02) ran from April 2024 to May 2026 and is now closed. National authorities had seen more adverse event reports for anticonvulsant hypersensitivity syndrome in dogs and cats, and for pancreatitis, elevated serum lipids and elevated liver enzymes in dogs.

The CMDv concluded that the benefit-risk balance of phenobarbital-containing products is unchanged. It recommended varying the marketing authorisations to reflect the risks of pancreatitis, elevated serum lipids and elevated liver enzymes in dogs, and recommended other risk minimisation measures for the signal in cats. For pancreatitis, the PhVWP-V advised adding it to the SPC section 3.6 adverse events table as 'uncommon', with a footnote on increased risk with potassium bromide, plus an interaction warning in section 3.8. It also advised adding serum lipid monitoring to section 3.5. The source text is cut off before the full recommendation on liver enzymes.

What it means for your team

  • MAHs for veterinary products should check that their signal submissions use the revised assessment report template (Rev.2) and follow the updated best practice guide.
  • Check the annual statement due dates in the June 2026 update of the recommended due-dates spreadsheet.
  • Holders of phenobarbital veterinary products should prepare variations reflecting the CMDv recommendations on SPC sections 3.5, 3.6 and 3.8, and review the full outcome for the liver enzyme and cat recommendations.

Official source: EMA · PRAC ↗

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

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