What EMA’s Veterinary Committee Decided at Its October Meeting
What EMA’s Veterinary Committee Decided at Its October Meeting
The European Medicines Agency's Committee for Veterinary Medicinal Products (CVMP) adopted a series of decisions covering veterinary vaccines, animal medicines, marketing authorisations, product variations and regulatory procedures during its October meeting.
The committee met from 6 to 8 October 2026 and issued positive opinions on two veterinary medicinal products, including a live vaccine against lumpy skin disease in cattle and a stem-cell-based treatment for chronic inflammatory enteropathy in dogs.
Positive Opinion for Lumpy Skin Disease Vaccine
One of the key decisions was a positive opinion for Bovilis Lumpyvax, a live vaccine developed for the active immunisation of cattle against lumpy skin disease.
The vaccine contains a live attenuated Neethling strain of lumpy skin disease virus. EMA's CVMP recommended authorisation under exceptional circumstances for reducing clinical signs and viraemia associated with lumpy skin disease virus infection.
The recommendation follows growing attention to lumpy skin disease control in Europe. The disease can cause significant illness in cattle and is primarily transmitted by biting insects.
The CVMP's positive opinion is a regulatory recommendation rather than the final EU-wide marketing authorisation. The European Commission is responsible for issuing the legally binding authorisation decision.
Stem-Cell Treatment for Dogs Receives Positive Opinion
The committee also adopted a positive opinion for Stemyca, a veterinary medicinal product containing equine umbilical cord mesenchymal stem cells.
The treatment is intended to reduce clinical signs associated with non-food-responsive chronic inflammatory enteropathy (CIE) in dogs.
The positive opinion represents another development in veterinary regenerative medicine, where cell-based approaches are being investigated and developed for the treatment of diseases in companion animals.
The product's regulatory assessment was among the new marketing-authorisation applications considered during the October CVMP meeting.
Mirataz Product Information Updated
The committee also adopted a positive opinion concerning a variation to the marketing authorisation for Mirataz, which contains mirtazapine.
The variation updates the product information based on new target-animal safety data. The summary of product characteristics and package leaflet were updated to reflect that administration of Mirataz at overdose was associated with some known adverse events, including erythema and alopecia at the application site.
The decision illustrates the continuing role of pharmacovigilance and post-authorisation safety monitoring in veterinary medicines.
One-Year Extension Recommended for Avian Influenza Vaccine
The CVMP also issued a positive opinion following the re-examination of Vaxxitek HVT+IBD+H5, an avian influenza vaccine.
The committee recommended extending the validity of the product's marketing authorisation for one additional year under exceptional circumstances.
The product is an example of how veterinary medicines can remain subject to additional regulatory review when authorisations are granted or maintained under exceptional circumstances.
CVMP Reviews Vetmedin Indication
Another important decision concerned Vetmedin 1.5 mg/ml oral solution for dogs, which contains pimobendan.
The procedure followed a lack of consensus between EU Member States during a review under the Veterinary Coordination Group for Mutual Recognition and Decentralised Procedures. The European Commission subsequently requested clarification from the CVMP under Article 54(8) of Regulation (EU) 2019/6 concerning a proposed variation to add an indication.
After reviewing the Commission's request and available data, the CVMP concluded by majority that the benefit-risk balance for the proposed indication was positive.
The committee's clarification will now be sent to the European Commission for consideration.
Scientific Advice Covers Atlantic Salmon Products
Beyond marketing authorisations, the October meeting included scientific advice procedures.
The CVMP adopted two scientific advice reports concerning veterinary products for Atlantic salmon. EMA did not disclose further product details in the meeting highlights.
Scientific advice enables developers to obtain regulatory guidance during the development of veterinary medicinal products, including issues related to study design, quality, safety and efficacy.
Limited-Market Classification for a Canine Product
The committee also considered an application under the EU's limited-market provisions.
Following one request, the CVMP classified a product in the antiparasitic, insecticide and repellent category for dogs as intended for a limited market. However, it was determined that the product was not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
Limited-market provisions are designed to address situations where a veterinary medicinal product may serve a restricted population or market and where conventional commercial development may otherwise be challenging.
Pharmacovigilance Signals Reviewed
The committee also adopted the outcomes of its monthly signal-management process.
Pharmacovigilance activities involve monitoring safety information that may emerge after veterinary medicines enter the market. Marketing authorisation holders submit potential safety signals, which are assessed through the EU veterinary pharmacovigilance system.
EMA said the signals submitted during the month are available through the IRIS public portal, using the relevant signal-management submission filter.
October Meeting Shows Broad Veterinary Regulatory Activity
The October CVMP meeting covered a broad range of veterinary medicines and regulatory procedures, from new vaccines and cell-based treatments to safety updates, product variations and scientific advice.
The positive opinion for Bovilis Lumpyvax was particularly significant for cattle health, while the recommendation for Stemyca highlighted continuing development of advanced veterinary therapies for companion animals.
Other decisions demonstrated the continuing regulatory work required after veterinary products reach the market, including safety monitoring, product-information updates and reassessment of authorisations.
The CVMP's decisions will feed into the relevant EU regulatory processes, with the European Commission responsible for certain final marketing-authorisation decisions following EMA opinions.
Sources:
Bitumen
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