Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 May 2024
News
Veterinary
Medicines
CVMP opinions on veterinary medicinal products
The Committee adopted by consensus a positive opinion for a marketing authorisation for Nobilis Multriva RT+IBm+ND+EDS, from Intervet International B.V., a new vaccine intended for the active immunisation of chickens for reduction of egg drop caused by avian metapneumovirus, reduction of respiratory signs and egg drop caused by infectious bronchitis virus strains, reduction of mortality and clinical signs caused by Newcastle disease virus and reduction of egg drop and eggshell defects caused by egg drop syndrome ’76 virus.
The Committee adopted by consensus a positive opinion for a marketing authorisation for Nobilis Multriva RT+IBm+ND+Gm+REOm, from Intervet International B.V., a new vaccine intended for the active immunisation of chickens for reduction of egg drop caused by avian metapneumovirus, reduction of respiratory signs and egg drop caused by infectious bronchitis virus strains, reduction of mortality and clinical signs caused by Newcastle disease virus and for the passive immunisation of the progeny of the vaccinated chickens to reduce mortality and clinical signs of disease caused by strains of infectious bursal disease virus, and to reduce viraemia and clinical signs of disease caused by avian reovirus.
The Committee adopted by consensus a positive opinion for a grouped variation requiring assessment for Bluevac BTV (Bluetongue virus vaccine (inactivated)) concerning a change to the multistrain dossier to allow up to two different inactivated bluetongue virus serotypes in the final product (bivalent vaccine) and a quality related change.
The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:
- Contacera
- Felpreva
- Locatim
- MS-H Vaccine
- Nobivac LoVo L4
- Rabitec
- Tulissin (grouped)
The Committee adopted by consensus positive opinions for variations requiring assessment to align the product information with version 9.0 of the QRD template for:
- Circovac
- Forceris
- Isemid
- Nobivac LoVo L4
- Porcilis AR-T DF
- Vectra Felis
- Vectra 3D
- Virbagen Omega
Scientific advice
The Committee adopted two scientific advice reports further to requests for initial advice of which one concerned immunological products for dogs and the other one a herbal substance for salmon.
Organisational matters
The Committee adopted the draft consolidated 3-year work plan for the veterinary domain (2025-2027) for stakeholders’ consultation.
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”.
The Committee held a meeting with its Interested Parties on 22 May 2024, attended by representatives of Access VetMed, AnimalhealthEurope, Association of Veterinary Consultants (AVC), COPA-COGECA, Federation of Veterinarians of Europe (FVE), Groupement Pharmaceutique de l’Union Européenne (PGEU) and International Council on Animal Protection in Pharmaceutical Programs (ICAPPP).
The topics discussed concerned:
- Benefit-risk guideline
- Guidance to Applicants
- ERA and companion animal parasiticides
- Innovation in use of data to support medicines registration
- 3R’s
- Biosimilars
- Development of scientific advice relating to the list of substances which are essential for the treatment of equine species (article 115(5) of Reg 2019/6/EC) and the list of substances which may be used in food-producing aquatic species (article 114(3)
- New guideline on consumer safety for immunological veterinary medicinal products for endogenous targets
- Discussion on LD50 test
- Update on activities by the Antimicrobials Working Party and the Antimicrobial Advice Ad Hoc Expert Group (AMEG) and AMR Training Workshops
- Update on CVMP activities in respect to setting MRLs for essential oils.