EMA CVMP meeting highlights 8–10 September 2026

CVMP opinions on veterinary medicinal products

The Committee adopted positive opinions for marketing authorisations and variations for several VMPs: Cirbloc for active immunisation of pigs from three weeks of age against porcine circovirus type 2 (PCV2); AviGate S. Typhimurium for active immunisation of healthy chickens against Salmonella Typhimurium; and a variation for Vectormune HVT‑AIV to add turkeys as a target species and increase the minimum titre per dose. Variations were also adopted to add horses for Firocoxib CP‑Pharma, to provide missing stability data supporting a 36‑month shelf‑life for Innovax ND‑H5, to add tick indications for Felpreva, and to extend Vectra 3D’s indication to reduce Leishmania infantum infection risk for one month post‑administration.

The Committee approved safety‑related label updates following MAH signal management outcomes: Credelio/AdTab to include ‘seizure’ as a very rare adverse event, Easotic to include ‘application site inflammation’ as very rare, and Galliprant to include ‘gastrointestinal ulceration’ as very rare.

Procedure under Article 141(1)(i)

The CVMP agreed to extend the timetable for scientific advice on VMPs containing amoxicillin (single substance) for use in drinking water or feed in pigs for respiratory indications, reflecting the revised timeline for the ADRA temporary working party report and adding a 2‑month public consultation before final adoption.

Maximum residue limits

The Committee amended the entry for macrogol cetostearyl ether in the list of substances considered outside the scope of Regulation (EC) No 470/2009 to include intradermal and intramuscular administration and adopted the revised list (EMA/CVMP/519714/2009‑Rev.63).

Scientific advice and limited markets

Three scientific advice reports were adopted for an immunological product for salmon, a pharmaceutical for dogs and a biological for cats, and a clarification response for an immunological product for dogs was endorsed. The CVMP classified one nervous‑system product for horses as limited market and not eligible under Article 23, and one immunological product for Atlantic salmon as limited market and eligible under Article 23.

Concept papers, guidelines and working parties

The Committee adopted a concept paper to revise the antimicrobial SPC guideline and a revised VGVP Module: Signal Management guideline for 3‑month public consultations, plus a Q&A on post‑approval change management protocols and revised user‑safety guidelines for pharmaceutical and topical VMPs for 3‑month consultation. Sonia Gil Morales was elected chair of the Efficacy Working Party (EWP‑V) for a three‑year mandate.