Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-18 June 2026
Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting
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The Committee adopted a negative opinion for a marketing authorisation for Scovella (velagliflozin), a product classified as intended for a limited market, for the treatment of hyperinsulinaemia and associated clinical signs (e.g., laminitis) in insulin-dysregulated horses and ponies not responsive to changes in husbandry and exercise regimen.
The Committee adopted a revised positive opinion for a marketing authorisation for Nobivac NXT HCPChFeLV, for active immunisation of cats to reduce mortality, clinical signs and virus excretion caused by infection with feline herpesvirus type 1 (FHV); to reduce the clinical signs and virus excretion caused by infection with feline calicivirus (FCV); to prevent mortality, clinical signs, leucopenia and virus excretion caused by infection with feline panleucopenia virus (FPL); to reduce the clinical signs and bacterial excretion caused by infection with Chlamydia felis; and to reduce persistent viraemia and clinical signs caused by feline leukaemia virus (FeLV).
The Committee adopted a positive opinion for a marketing authorisation for Nobivac NXT FeLV, for active immunisation of cats to reduce persistent viraemia and clinical signs caused by feline leukemia virus (FeLV).
The Committee adopted a positive opinion for a marketing authorisation for Nobivac NXT HCPFeLV for active immunisation of cats against feline calicivirus, feline herpesvirus type 1, feline panleukopenia virus and feline leukemia virus.
The Committee adopted a positive opinion on the re-examination of Innovax ND-H5, an avian influenza vaccine. The Committee recommended the extension for one year of the validity of the marketing authorisation in exceptional circumstances.
The Committee adopted three scientific advice reports for two pharmaceutical products (one for honey bees and the other one for cats), and one immunological product for dogs.
Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
Following a request, the CVMP classified a product (ATCvet classification: antiparasitic products, insecticides and repellents) for dogs as intended for a limited market but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
Immunologicals
The Committee adopted a concept paper for the revision of the Guideline on data requirements for authorisation of immunological veterinary medicinal products in exceptional circumstances (EMA/CVMP/IWP/251947/2021) for release for a 3-month period of public consultation. This concept paper has been developed following the experience gained with the first marketing authorisation applications submitted under Art. 25, to provide greater clarity and to ensure consistent interpretation and application of the requirements.
The Committee adopted a concept paper for the revision of the Guideline on data requirements for the replacement of established master seeds (MS) already used in authorised immunological veterinary medicinal products (IVMPs) by new MS of the same origin (EMEA/CVMP/IWP/105504/2007) and integration with the Reflection paper on the replacement of cell lines used for the production of immunological veterinary medicinal products (EMA/CVMP/IWP/37620/2014) for release for a 3-month period of public consultation. The revision aims to update and streamline the guidance by aligning it with current legislation and providing clearer data requirements for master seed replacement.
Pharmacovigilance
The Committee adopted the following standard list and associated documents for electronic reporting of suspected adverse reactions following the yearly review and update:
The implementation of the standard VeDDRA list in EudraVigilance Veterinary is provisionally scheduled for 1 October 2026.
Antimicrobial resistance
The Committee adopted a document providing an overview of ‘CVMP activities related to antimicrobials’. This overview builds on the previous ‘CVMP Strategy on Antimicrobials’, which concluded its cycle in 2025. The first part of this document presents a status report on antimicrobial-related activities undertaken by the CVMP between 2021 and 2025. The second part outlines ongoing and planned activities in this strategic area, in line with EMANS 2028, Theme 4, and the overarching ‘One Health’ approach.
The Committee elected Rosario Bullido as chair of the Immunologicals Working Party (IWP) for a 3-year mandate.
The Committee elected Anita Bottger as chair of the Pharmacovigilance Working Party (PhVWP-V) for a 3-year mandate.
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”.