The July meeting of the Committee for Veterinary Medicinal Products (CVMP) covered product opinions, a Union referral, scientific advice outcomes, and several guideline updates spanning fixed combinations, novel RNA-based therapies and pharmacovigilance.
The Committee adopted a positive opinion for Bexatil, which reduces hyperglycaemia in cats with diabetes mellitus not previously treated with insulin. It also adopted variations for Mometamax Ultra and Cimalgex, both updating safety information following routine signal management. Mometamax Ultra adds deafness, impaired hearing, application site inflammation and application site pruritus as very rare adverse events, while Cimalgex sees the frequency of elevated renal parameters and renal failure reclassified from very rare to rare.
A notable procedural item was the Union referral for Vetmedin 1.5 mg/ml oral solution for dogs (pimobendan). The European Commission referred the matter to the CVMP under Article 54(8) of Regulation (EU) 2019/6, after Member States failed to reach consensus in the CMDv’s review of a variation to add a new indication on efficacy grounds, a reminder that even well-established products can face diverging national views once new claims are proposed.
The Committee also adopted three scientific advice reports, covering one immunological and two biological (non-immunological) products for Atlantic salmon, horses and dogs, along with a clarification of an earlier scientific advice report for a biological product for cats.
Regarding guidelines, the Committee adopted a concept paper (EMA/CVMP/EWP/54206/2026) for the revision of the guideline on pharmaceutical fixed combination products, open for a three-month public consultation until 31 October. It also adopted a concept paper on the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies as veterinary medicinal products, also open for consultation until 31 October, an early signal of how the CVMP is preparing to regulate this emerging therapeutic class.
Separately, the Committee finalised administrative-only revisions to two existing guidelines, on strain composition changes for authorised influenza vaccines and on in-use stability claims for veterinary vaccines, aligning both with Regulation (EU) 2019/6 terminology. As no scientific content changed, neither required a concept paper or consultation, and both come into effect on 16 January 2027. The current versions remain the point of reference until then, as listed on the European Medicines Agency (EMA) immunologicals guidelines page.
A draft revision to the veterinary good pharmacovigilance practices (VGVP) module on pharmacovigilance systems and their quality management was also adopted for a two-month consultation (EMA/INS/PhV/68655/2026). This document has not yet been published individually; once available, it will be listed on the EMA’s Open Consultations page.
On classifications, one antineoplastic and immunomodulating product for dogs was designated for a limited market and made eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
Finally, the Committee elected Kathrin Schirmann as Vice-Chair of the Pharmacovigilance Working Party - Veterinary, and re-elected Marie-Hélène Sabinotto as Veterinary Vice-Chair of the Quality Working Party, both for three-year mandates.
A full account of the discussions is available in the EMA’s meeting highlights.
