EMA CVMP Meets 8–10 September: Veterinary Medicine Decisions in Focus

Amsterdam, September 8, 2026 — The European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) is meeting from 8–10 September 2026, with a substantial agenda spanning new veterinary medicines, vaccines, parasiticides, antimicrobial policy, pharmacovigilance, safety and post-authorisation regulatory requirements.

The three-day meeting is taking place at EMA headquarters in Amsterdam, with the formal session scheduled from 09:00 on September 8 to 13:00 on September 10. EMA published the draft agenda on September 7.

For the animal-health industry, the meeting is notable because several applications and regulatory procedures are moving toward CVMP opinions or decisions, potentially affecting product development, market access and lifecycle strategies across Europe.

Three new veterinary medicines on the opinion agenda

Among the most important items are three marketing-authorisation applications listed for adoption of CVMP opinions:

• Porcine circovirus type 2d (PCV2d) ORF2 capsid protein for pigs, aimed at reducing viraemia, virus load in lungs and lymphoid tissues, and virus shedding associated with PCV2 infection.

• Live Salmonella Typhimurium vaccine for chickens, intended to reduce organ colonisation and faecal excretion.

• Equine umbilical cord-derived mesenchymal stem cells for dogs, targeting reduction of clinical signs associated with non-food-responsive chronic inflammatory enteropathies.

The portfolio is strategically significant because it spans swine health, poultry vaccination and advanced companion-animal therapies, illustrating the breadth of the EU veterinary medicines pipeline.

Further pipeline decisions under review

The CVMP is also considering outstanding issues involving a canine distemper/adenovirus/parainfluenza/parvovirus/leptospirosis vaccine, a recombinant Streptococcus suis vaccine for pigs, and fuzapladib sodium for dogs with acute pancreatitis. The agenda includes decisions on whether further oral explanations are required and adoption of scientific assessments.

An equine interleukin-5 vaccine is also scheduled for an oral explanation on September 8. The product is designed to induce antibodies against equine interleukin-5 in horses affected by a hyper-eosinophilic condition.

Avian influenza and livestock disease vaccines in focus

The meeting has particular relevance for infectious-disease prevention. CVMP is scheduled to consider a variation for Vectormune HVT-AIV, an avian-influenza vaccine, to add turkeys as a new target species and introduce a new strength.

Another avian-influenza product, Innovax ND-H5, is undergoing review of stability data supporting its proposed 36-month shelf life.

The agenda also includes questions relating to two epizootic haemorrhagic disease (EHD) vaccines for cattle — Hepizovac and Orbyk EHD — as well as Syvazul BTV 3, a bluetongue virus serotype 3 vaccine for sheep. The outstanding issues relate principally to stability, potency testing and duration-of-immunity data.

These items are commercially relevant as Europe continues to manage expanding vector-borne disease risks affecting cattle and sheep.

Companion-animal market sees multiple lifecycle decisions

The September agenda also contains a sizeable companion-animal component. CVMP is considering variations involving Credelio/AdTab (lotilaner), Felpreva, Firocoxib CP-Pharma, Easotic, Vectra 3D, and Galliprant.

The proposed changes include new indications, target-species extensions and implementation of pharmacovigilance signal-management outcomes. For example, Felpreva is being assessed for an expanded tick indication covering Ixodes hexagonus, Rhipicephalus sanguineus and Haemaphysalis longicornis, while Vectra 3D is being assessed for an indication relating to reduction of Leishmania infantum transmission through Phlebotomus species.

Antimicrobial and pharmacovigilance policy also on agenda

Beyond individual products, the meeting contains several policy developments with potentially broader industry implications.

The Antimicrobials Working Party is scheduled to consider adoption of a concept paper for revision of the CVMP guideline covering the summary of product characteristics for veterinary medicinal products containing antimicrobial substances.

The Pharmacovigilance Working Party is considering adoption of a guideline on signal management under veterinary good pharmacovigilance practices.

CVMP will also consider updated guidance on user safety for pharmaceutical veterinary medicinal products, including a specific guideline for topically administered veterinary medicines.

For manufacturers, these developments matter because regulatory expectations around antimicrobial stewardship, post-market safety monitoring and product information increasingly influence the full lifecycle of veterinary medicines.

Potential commercial significance

The September CVMP meeting therefore extends well beyond a routine regulatory calendar event. The agenda covers new product approvals, vaccines, advanced therapies, lifecycle extensions, pharmacovigilance, antimicrobial regulation and safety guidance across pigs, poultry, cattle, sheep, horses, dogs and cats.

For animal-health companies operating in Europe, the immediate focus will be on the final CVMP opinions and meeting highlights released following the meeting. EMA notes that some information in the draft agenda remains commercially confidential and that details may change during the review process.