Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 19-21 May 2026

CVMP opinions on veterinary medicinal products

The Committee adopted a positive opinion for a marketing authorisation for Nobivac NXT HC, for the active immunisation of cats against feline herpesvirus type 1 and feline calicivirus.

The Committee adopted a positive opinion for a marketing authorisation for Nobivax NXT HCP, for the active immunisation of cats against feline herpesvirus type 1, feline calicivirus and feline panleucopenia virus.

The Committee adopted a positive opinion for a marketing authorisation Nobivac NXT HCPCh for the active immunisation of cats against feline herpesvirus type 1, feline calicivirus, feline panleucopenia virus and Chlamydia felis.

The Committee adopted a positive opinion for a marketing authorisation Poulvac Procerta HVT-ND, for the active immunisation of one-day-old chickens and 18- to 19-day-old embryonated chicken eggs against Marek’s disease and Newcastle disease.

The Committee adopted a positive opinion for a variation for BTVPUR (Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) to include a new vaccination practice against BTV8 in sheep.

The Committee adopted a positive opinion for a variation for Librela(bedinvetmab) to implement the outcome of the MAH’s signal management process to update the product information by adding “Joint swelling, Joint pain, Bone and Joint disorder and Arthritis” as very rare adverse events. Other, related changes were made within the product information, including advice to consider performing additional diagnostics and discontinue treatment on a case-by-case basis where a dog presents with new or increased joint swelling and/or joint pain following Librela treatment.

The Committee adopted a positive opinion for a variation for Vectormune HVT-AIV (avian influenza vaccine (live recombinant)) fulfilling the specific obligation to provide results of duration of immunity studies.

The Committee adopted a positive opinion for a variation for Neptra (florfenicol / terbinafine hydrochloride / mometasone furoate) to implement the outcome of the MAH's signal management process to update the product information by adding “Hypersensitivity reactions (e.g. facial oedema, urticaria and anaphylaxis)” as very rare adverse events.

The Committee adopted a positive opinion for a variation for Respivac aMPV (turkey rhinotracheitis virus, live) to add turkeys as a new target species and to establish a higher minimum composition per dose in chickens than the one currently authorised.

The Committee adopted a positive opinion for a worksharing procedure for Enteroporc Coli AC (neonatal piglet colibacillosis (recombinant, inactivated) and Clostridium perfringens vaccine (inactivated)) for mixed, associated use of the vaccine and other nationally authorised products.

The Committee adopted a positive opinion for a variation for Hepizovac (epizootic haemorrhagic disease vaccine (inactivated)) fulfilling the specific obligation regarding the stability of the antigen at 18 months of storage.

Scientific advice

The Committee adopted four scientific advice reports following initial requests concerning two immunological products and two pharmaceutical products. The target species were cattle (two), horses (one) and turkeys (one).

The Committee endorsed a clarification of a scientific advice report concerning a pharmaceutical product for dogs.

Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6

Following two requests, the CVMP classified:

A product (ATCvet classification: sensory organs) for dogs as intended for a limited market and not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
A product (ATCvet classification: alimentary tract and metabolism) for dogs and cats as not intended for a limited market according to Article 4(29) of Regulation (EU) 2019/6.

Pharmacovigilance

The Committee adopted the outcomes of the signal management process for the current month. The signals submitted by marketing authorisation holders are listed, in chronological order, in the IRIS public portal: List of signals from Veterinary Signal Management. In order to access the list, the following filter should be applied in the ‘Submission type’ category: ‘Signal management submission’.

Concept papers, guidelines

Safety

The Committee adopted a revised guideline on determination of the need for an MRL evaluation for chemical-unlike biological substances (EMA/CVMP/SWP/591282/2026). The revision will come into effect on 29 May 2026.

International harmonisation

The Committee adopted VICH GL61 on Pharmaceutical Development for implementation by April 2027.

Organisational matters

The Committee held a meeting with the interested parties on 20 May 2026 attended by representatives of Access VetMed, AnimalhealthEurope, Association of Veterinary Consultants, Federation of Veterinarians of Europe and International Council on Animal Protection in Pharmaceutical Programs.

The topics discussed concerned:

3Rs activities at the CVMP: quality control testing, environmental risk assessment, toxicity testing including LD₅₀ tests, virtual control groups methodology;
European Veterinary Medicines gaps and needs compass for sheep and goats;
CVMP current priorities.

More information about the above-mentioned medicines (including their full indications), guidelines, reflection papers, questions and answers and other documents, such as overviews on comments received during consultation, can be found below in “Related content”.