Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-15 May 2025
Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting
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The Committee re-elected Johan Schefferlie from the Netherlands as its Chair for a further 3-year mandate.
CVMP opinions on veterinary medicinal products
The Committee adopted by consensus a positive opinion for a marketing authorisation from Intervet International B.V. for Innovax-ND-IBD-ILT, for the active immunisation of one-day-old chicks or 18-19 day-old embryonated chicken eggs to reduce mortality and clinical signs caused by Newcastle disease (ND) virus and to reduce mortality, clinical signs and lesions caused by avian infectious laryngotracheitis (ILT) virus, Marek’s disease (MD) virus and infectious bursal disease (IBD) virus.
The Committee adopted by consensus a positive opinion for a marketing authorisation from Intervet International B.V. for Fluralaner Intervet (fluralaner) for the treatment of flea and tick infestations in dogs for one month. It can also be used as part of a treatment strategy for the control of flea allergy dermatitis. In addition, it reduces the risk of infection with Babesia canis canis and Dipylidium caninum via transmission from ticks and fleas.
The Committee adopted by consensus a positive opinion for a marketing authorisation from Intervet International B.V. for Nobilis Multriva IBm+ND+Gm+REOm+EDS, for the active immunisation of chickens for reduction of respiratory signs and egg drop caused by infectious bronchitis virus (IBV) strains Massachusetts (GI-1 genotype) and 4/91-793B (GI-13 genotype); reduction of mortality and clinical signs caused by Newcastle disease virus (NDV); passive immunisation of the progeny of the vaccinated chickens to reduce mortality and clinical signs of disease caused by very virulent (CS89) and classical (STC) strains of infectious bursal disease virus (IBDV); reduction of viraemia and clinical signs of disease caused by avian reovirus (ARV) genotypes 1 and 4.; reduction of egg drop and eggshell defects caused by eggdrop syndrome-1976 virus (EDSV).
The Committee adopted by consensus a positive opinion for grouped variations requiring assessment for NexGard Combo (esafoxolaner/ eprinomectin/ praziquantel) concerning addition of a new therapeutic indication or modification of an approved one: treatment of infections with eye worms (Thelazia callipaeda) and immediate tick killing activity against Ixodes hexagonus.
The Committee adopted by consensus a positive opinion for a variation requiring assessment for Stronghold Plus (selamectin/ sarolaner) concerning addition of a new therapeutic indication or modification of an approved one: reduction of the risk of infection with Dipylidium caninum via transmission by Ctenocephalides felis for one month after treatment.
The Committee adopted by consensus a positive opinion for a variation requiring assessment for Bluevac BTV (Bluetongue virus vaccine (inactivated)) to change the posology for sheep, to vaccinate with one single dose of the bivalent vaccine BTV-1+4.
The Committee adopted by consensus a positive opinion for a variation requiring assessment for Divence Penta (bovine viral diarrhoea (subunit), bovine parainfluenza 3 virus (inactivated), bovine respiratory syncytial virus and bovine herpesvirus type 1 (live) vaccine) to implement the outcome of the MAH's signal management process to add new uncommon adverse events to the product information (milk production decrease, reduced food intake and decreased activity). Information on allowing the vaccine to reach room temperature before use was also added to the product information.
The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:
- Mirataz
- Pexion (grouped)
- Profender, Procox, Felpreva (worksharing procedure)
The Committee adopted by consensus positive opinions for variations requiring assessment to align the product information with version 9/9.1 of the QRD template for:
- Coxatab
- DogStem
- HorStem
- Melovem
- Oncept IL-2
- Profender
Withdrawal of applications
The Committee was informed of the formal notification from AVI Medical B.V. of their decision to withdraw the application for an initial marketing authorisation for Cunitraxx. More information about this application and the 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.
Maximum residue limits
The Committee adopted by consensus an opinion recommending the establishment of provisional maximum residue limits for lidocaine for injection into scrotum, testicles and spermatic cord in piglets up to 7 days of age and not intended for slaughter within 50 days. Lidocaine is currently included in Table 1 (Allowed substances) of the Annex to Commission Regulation (EU) No 37/2010 with MRLs established for Equidae, porcine and bovine species but with restrictions to its use. The CVMP opinion recommends that, following their incorporation into Commission Regulation (EU) No 37/2010, the provisional MRLs will expire on 31 December 2027.
Scientific advice
The Committee adopted one scientific advice report for a pharmaceutical product for cats.
Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
Following two requests for classification, the CVMP classified:
A product (ATCvet classification: immunologicals) for dogs as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
A product (ATCvet classification: alimentary tract and metabolism) for horses as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
Concept papers, guidelines
Safety
The Committee adopted a concept paper on the development of a guideline on consumer safety of active substances of immunological veterinary medicinal products acting against endogenous targets (EMA/CVMP/SWP/564861/2023) for release for a 3-month period of public consultation.
Legislation
The Committee adopted a reflection paper on the application of Article 40(5) of Regulation (EU) 2019/6 for certain categories of variations (EMA/CVMP/55240/2025).
The Committee adopted the scientific advice under Article 114(3) of Regulation (EU) 2019/6 for the establishment of a list of substances which may be used in food-producing aquatic species in accordance with Article 114(1).
Working parties
The Committee elected Mark Montforts as chair of the ERAWP for a 3-year mandate.
The Committee elected Paul McNeill as chair of the SAWP-V for a 3-year mandate.
The Committee elected Anja Pfalzgraff as vice-chair of the NTWP for a 3-year mandate.
Organisational matters
The CVMP meeting was followed by the Interested Parties meeting on 14 May 2025 where the following topics were discussed:
- Update on FVE cascade brochure;
- Update on scientific advice to the European Commission on the list of substances which may be used in food-producing aquatic species in accordance with Article 114(1) of Regulation (EU) 2019/6;
- Transparency on the periods of protection of technical documentation as presented in the Commission’s Guidance to Applicants;
- Experience with implementation of the guideline on the SPC for VMPs containing antimicrobial substances;
- Follow-up on guidelines and/or legislation perceived to be obstacles to innovation;
- Limited Markets and the validity period of their classification;
- CVMP activities on 3Rs.
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”.