Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 July 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 Bexatil for the reduction of hyperglycaemia in cats with diabetes mellitus not previously treated with insulin.
The Committee adopted a positive opinion for a variation for Mometamax Ultra to implement the outcome of the MAH's signal management process to include ‘deafness’, ‘impaired hearing’, ‘application site inflammation’ and ‘application site pruritus’ as ‘very rare’ adverse events.
The Committee adopted a positive opinion for a variation for Cimalgex to implement the outcome of the MAH's signal management process to change the frequency of the adverse events ‘elevated renal parameters’ and ‘renal failure’ from ‘very rare’ to ‘rare’.
Union referrals and related procedures
The Committee started a procedure for Vetmedin 1.5 mg/ml oral solution for dogs (pimobendan) from Boehringer Ingelheim Vetmedica GmbH, Germany. The matter was referred to the Committee by the European Commission under Article 54(8) of Regulation (EU) 2019/6 due to lack of consensus between Member States in the CMDv’s review procedure on a variation requiring assessment to add a new indication, on the grounds of efficacy.
Scientific advice
The Committee adopted three scientific advice reports for one immunological and two biological (non-immunological) products for Atlantic salmon, horses, and dogs (one product each).
The Committee endorsed a clarification of a scientific advice report concerning a biological (non-immunological) product for cats.
Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
The Committee 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’.
Concept papers, guidelines
Efficacy
The Committee adopted a concept paper (EMA/CVMP/EWP/54206/2026) on the revision of the guideline on pharmaceutical fixed combination products (EMA/CVMP/83804/2005) for a 3-month period of public consultation.
Immunologicals
The Committee adopted a revised guideline on data requirements for changes to the strain composition of authorised influenza vaccines in line with WOAH recommendations (EMA/CVMP/IWP/97961/2013). The current revision consists of administrative changes made in order to align the guideline to the definitions and terminology provided by Article 4 of Regulation (EU) 2019/6. The references to the applicable legislation and other scientific guidelines have also been updated. As no changes were made to the scientific content, no concept paper and no public consultation were deemed necessary. The revision will come into effect on 16 January 2027.
The Committee adopted a revised guideline on data requirements to support in-use stability claims for veterinary vaccines (EMA/CVMP/IWP/250147/2008 – Rev.1). The current revision consists of administrative changes made in order to align the guideline with Regulation (EU) 2019/6. As no changes were made to the scientific content, no concept paper and no public consultation were deemed necessary. The revision will come into effect on 16 January 2027.
Novel therapies
The Committee adopted a concept paper on the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies as veterinary medicinal products (EMA/156862/2026) for a 3-month period of public consultation.
Pharmacovigilance
The Committee adopted a draft revised VGVP Module on Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files (EMA/INS/PhV/68655/2026) for a 2-month period of public consultation.
Organisational matters
The Committee elected, unanimously, Kathrin Schirmann as vice-chair of the Pharmacovigilance Working Party - Veterinary, for a 3-year mandate.
The Committee elected, unanimously, Marie-Hélène Sabinotto as veterinary vice-chair of the Quality Working Party, for a further 3-year 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”.