By VETTAPHARMA reporter – Derek Roche: The European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) adopted a series of positive opinions following its 19–21 May 2026 meeting, published 22 May 2026, advancing new and updated veterinary products across companion animals and poultry. The committee recommended marketing authorisations for Nobivac NXT HC, Nobivac NXT HCP, Nobivac NXT HCPCh for cats and Poulvac Procerta HVT‑ND for one‑day‑old chickens and late‑stage embryonated eggs against Marek’s disease and Newcastle disease.
Regulatory actions included multiple product variations and obligations: a variation for BTVPUR to add a new vaccination practice against BTV8 in sheep; a variation for Vectormune HVT‑AIV fulfilling duration‑of‑immunity study obligations; and a variation for Hepizovac confirming antigen stability at 18 months. The committee also issued a positive opinion for a worksharing procedure for Enteroporc Coli AC and an expanded target‑species variation for Respivac aMPV to add turkeys and adjust minimum composition per dose in chickens.
Safety‑related label changes were a focus. The CVMP recommended updating Librela (bedinvetmab) product information to add “Joint swelling, Joint pain, Bone and Joint disorder and Arthritis” as very rare adverse events and advised clinicians to consider additional diagnostics and case‑by‑case discontinuation where new or increased joint swelling or pain occurs after treatment. A separate variation for Neptra added hypersensitivity reactions (facial oedema, urticaria, anaphylaxis) as very rare events.
Scientific and procedural outcomes included adoption of four scientific advice reports following initial requests for two immunological and two pharmaceutical products, targeting cattle (two), horses (one) and turkeys (one), plus endorsement of a clarification for a pharmaceutical product for dogs. The CVMP adopted the revised guideline EMA/CVMP/SWP/591282/2026 on determining the need for MRL evaluation for chemical‑unlike biological substances, effective 29 May 2026, and approved VICH GL61 on Pharmaceutical Development for implementation by April 2027.
Pharmacovigilance activity continued with the committee adopting the month’s signal‑management outcomes; stakeholders can review submitted signals in the IRIS public portal using the ‘Signal management submission’ filter. The CVMP also met interested parties on 20 May 2026 to discuss 3Rs activities, environmental risk assessment, virtual control groups, and gaps for sheep and goats, reflecting an ongoing emphasis on harmonisation, animal welfare, and targeted market needs.
