Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 March 2026

CVMP opinions on veterinary medicinal products

The Committee adopted a positive opinion for a marketing authorisation for AviGate S. Infantis, for active immunisation of healthy chickens to reduce faecal excretion and colonisation of internal organs with Salmonella infantis.

The Committee adopted a positive opinion for a marketing authorisation for VeroBlue-3, for active immunisation of sheep to reduce viraemia and pyrexia caused by serotype 3 of the bluetongue virus.

Re-examinations of marketing authorisations in exceptional circumstances

The Committee adopted an opinion on the re-examination of Syvazul BTV-3, a bluetongue virus vaccine (inactivated). The Committee recommended the extension for one year of the validity of the marketing authorisation in exceptional circumstances.

Withdrawal of applications

The Committee was informed of the formal notification from Intervet International B.V. of their decision to withdraw the application for a variation requiring assessment for Mometamax Ultra. More information about this application and the current state of the scientific assessment at the time of the withdrawal will be made available in a public assessment report. The document, together with the withdrawal letter from the applicant, will be published on the Agency’s website in due course.

Procedure under Article 141(1)(i) of Regulation (EU) 2019/6

The Committee concluded a procedure on quarter-based selective antibiotic dry cow therapy. The procedure responds to a request from Germany for the Committee to provide a scientific advice under Article 141(1)(i) of Regulation (EU) 2019/6.

Based on the assessment of the available scientific evidence, the CVMP considered that quarter-based selective antibiotic dry cow therapy is consistent with the latest scientific knowledge aimed at reducing antibiotic use, without compromising animal health. The CVMP deliberated on how this approach could be reflected in the product information (summary of product characteristics and package leaflet) of the relevant intramammary dry cow antibiotic veterinary medicines. Such information may assist veterinarians and farmers in determining whether cow based or quarter based selective antibiotic dry cow therapy is more appropriate under specific herd conditions.

The scientific advice and assessment report will be published on the Agency’s website.

Scientific advice

The Committee adopted five scientific advice reports for two immunological and three pharmaceutical products for dogs (four products) and horses (one product). The Committee also endorsed a clarification of a scientific advice report for an immunological product for dogs.

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

Following one request, the CVMP classified a product (ATCvet classification: antineoplastic and immunomodulating agents) for dogs as intended for a limited market and eligible for authorisation under Article 23 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’.

CVMP recommends updating Librela’s product information

The Committee recommended that the product information for Librela (bedinvetmab), a medicine for the alleviation of pain caused by osteoarthritis in dogs, be updated. This follows a review which concluded that very rare cases of musculoskeletal disorders may occur in dogs treated with Librela.

The recommendation is based on the evaluation of a review requested from the marketing authorisation holder, Zoetis, and of reports of suspected cases of musculoskeletal disorders in the Union Pharmacovigilance Database.

Sections 3.5 ‘Special precautions for use’ and 3.6 ‘Adverse events’ of the product information should be updated to include information on very rare cases of musculoskeletal adverse events that may occur in dogs treated with Librela.

In addition to this request to update the product information, the MAH was asked to continue to closely monitor cases of suspected musculoskeletal disorders and to keep EMA updated.

The MAH is now expected to submit a variation without undue delay to update the product information to include the new information about musculoskeletal side effects. Further information will be included in the CVMP highlights after finalisation of the variation.

Concept papers, guidelines

Environmental Risk Assessment

The Committee adopted the revised guideline on the plant testing strategy for veterinary medicinal products (EMA/CVMP/ERA/689041/2015). No changes to the scientific content of the document have been made. The amendments made are only of editorial nature, with the aim to align the content of the documents with newly published/updated guidance (e.g. relevant OECD Test Guidelines) or to increase the clarity of text.

Novel therapies

The Committee adopted a guidance template for a risk management plan for novel therapies (EMA/CVMP/NTWP/201952/2025), required to be submitted as part of the initial marketing authorisation application for novel veterinary medicinal products. The risk management plan will be assessed by the CVMP as part of the evaluation of the marketing authorisation application, and a summary will be published as part of the European public assessment report (EPAR).

The template will be made available to applicants on the EMA website

Quality

The Committee adopted Questions & Answers on the Implementation of 3DP (three-dimensional printing) technology (Additive Manufacturing Technology) for solid oral dosage forms. The aim of this document is to provide guidance on quality and good manufacturing practice (GMP) requirements to support the use of 3DP technology in pharmaceutical manufacturing of solid oral dosage forms.

Organisational matters

The CVMP meeting was followed by EMA Veterinary Medicines Info Day 2026 on 12-13 March 2026 providing stakeholders with the latest updates on regulatory policy, and scientific and legislative developments in the veterinary domain.

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”.