Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 February 2026
Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting
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CVMP opinions on veterinary medicinal products
The Committee adopted a positive opinion for a marketing authorisation for Emepax (maropitant), indicated for the prevention of nausea induced by chemotherapy, for vomiting induced by motion sickness, prevention and for treatment of vomiting in dogs. The product is to be used in conjunction with maropitant solution for injection and in combination with other supportive measures.
The Committee adopted a positive opinion for a variation for Bluevac BTV (Bluetongue virus vaccine (inactivated)) to allow up to three different inactivated bluetongue virus serotypes to be included in the final vaccine.
The Committee adopted a positive opinion for a variation for Suvaxyn PRRS MLV (porcine respiratory and reproductive syndrome virus vaccine (live)) to introduce the possibility of using a needle-free device to administer the product (0.5 ml dose) via the intramuscular route in pigs for fattening.
The Committee adopted a positive opinion for a variation for Bravecto (fluralaner) to implement the outcome of the MAH’s signal management process to update to the product information by adding “Pruritus”, “Allergic oedema” and “Hypersensitivity reaction” as very rare adverse events. “Diarrhoea” and “Emesis” were also added as rare adverse events. The following sentence was also added: “If accidental skin exposure occurs, wash the skin immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with clean water.”
The Committee adopted a positive opinion for a variation for Coxevac (Coxiella burnetii vaccine (inactivated)) to implement the outcome of the MAH’s signal management process to update the product information by adding “milk production decrease” as a rare adverse event in cattle and sheep, and as a common adverse event in goats.
The Committee adopted a positive opinion for a variation for Yurvac RHD (rabbit haemorrhagic disease and RHDV2 vaccine (recombinant)) to implement the outcome of the MAH's signal management process to update the product information by adding “injection site lump, injection site mass, injection site nodule” as rare adverse events.
The Committee adopted positive opinions for two variation procedures for Versican Plus DHPPi/L4 (canine distemper, canine adenovirus, canine parvovirus and canine parainfluenza virus vaccine (live) and canine leptospirosis vaccine (inactivated)) and Versican Plus DHPPi/L4R (canine distemper, canine adenovirus, canine parvovirus and canine parainfluenza virus vaccine (live) and canine leptospirosis and rabies vaccine (inactivated)), respectively, to implement the outcome of the MAH's signal management process to update the product information by adding “injection site lump, injection site mass, injection site nodule” as rare adverse events.
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’.
Scientific advice
The Committee adopted three scientific advice reports, two reports for biological (non-immunological) products for cats and one immunological product for pigs.
Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
Following a request, the CVMP classified a product (ATCvet classification: immunologicals) for Atlantic salmon as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
Certification of vaccine platform technology master file (vPTMF)
The Committee issued a certificate for a vaccine platform technology master file (vPTMF). The certified vPTMF is based on the live herpesvirus of turkeys (rHVT), genetically modified to express one or more genes of interest.
Concept papers, guidelines
Efficacy
The Committee adopted a revised question and answer document on the information in section 4.2 of the SPC on pharmacodynamic properties for pharmaceutical products.
Immunologicals
The Committee adopted a draft guideline on the quality aspects of mRNA vaccines for veterinary use (EMA/CVMP/IWP/128476/2025) for a 6-month period of public consultation. The guideline mainly addresses the quality requirements for development, manufacture and control, which are specific to mRNA vaccines for veterinary use.
Quality
The Committee adopted a new guideline on risk management requirements for elemental impurities in veterinary medicinal products (EMA/CVMP/426245/2023) following the close of the public consultation. The comments received during the consultation procedure have been considered for the preparation of the guideline, which will come into effect in September 2026. The Committee adopted a guidance document on the implementation of the submission of risk assessments to control elemental impurities required by the European Pharmacopoeia in immunological veterinary medicinal products.
The Committee adopted a revised question and answer document on complex manufacturing processes for veterinary medicinal products.
Pharmacovigilance
The Committee adopted a concept paper for the revision of the Guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal management (EMA/522332/2021) for a one-month period of public consultation. The concept paper outlines the proposed revisions to the guideline, considering the experience gained in recent years and current scientific knowledge.
International harmonisation
The Committee adopted VICH GL34(R1) on Testing for the detection of Mycoplasma contamination for implementation. The guideline has been revised to make reference to the revised European Pharmacopoeia chapter on Mycoplasmas and to provide transparency on the way the guideline is implemented in the EU.
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 under 'Related content'.