The Committee adopted by consensus a positive opinion for a marketing authorisation in exceptional circumstances for Bluevac-3 (Bluetongue virus, serotype 3, strain BTV-3/NET2023, inactivated) from CZ Vaccines S.A.U., a new vaccine for the active immunisation of sheep to reduce the viraemia, mortality and clinical signs caused by the serotype 3 of the bluetongue virus, and for active immunisation of cattle to reduce the viraemia against the serotype 3 of the bluetongue virus.
The Committee adopted by consensus a positive opinion for a marketing authorisation in exceptional circumstances for Syvazul BTV3 (Bluetongue virus, serotype 3, strain BTV-3/NET2023, inactivated) from Laboratorios Syva, S.A., a new vaccine for the active immunisation of sheep to reduce viraemia, mortality, clinical signs and lesions caused by bluetongue virus serotype 3.
The Committee adopted by consensus a positive opinion for a marketing authorisation Nobilis Multriva REOm (avian reovirus, strain ARV-1, ARV-4, inactivated) from Intervet International B.V., a new vaccine for the active immunisation of chickens and to achieve passive immunisation of their progeny to reduce viraemia and clinical signs of disease caused by avian reovirus (ARV) genotypes 1 and 4.
The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:
The Committee concluded that the following chemical-unlike biological substances: bovine casein hydrolysate (bCNH), probiotic components including bacteria and yeasts, recombinant bovine IL-8 (His-tag), stem cells, and varroa destructor calmodulin gene-specific double-stranded interfering RNA EP15 (naked unmodified dsRNA) do not pose a risk to public health and that, consequently, they can be included in Table 1 of the Annex to Regulation (EU) No. 37/2010 with a ‘No MRL required’ classification.
Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
Following two requests, the CVMP classified:
Antimicrobials
The Committee adopted a guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animals (EMA/CVMP/AWP/706442/2013) following the close of the second public consultation. The revision will come into effect on 1 August 2025.
Efficacy
The Committee adopted a revised guideline on data requirements for veterinary medicinal products for zootechnical purposes (EMA/CVMP/EWP/37280/2023) following the close of the public consultation. The revision will come into effect on 1 August 2025.
Replacement, Reduction, Refinement of animal testing (3Rs)
The Committee adopted a draft revised reflection paper on the current regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs (EMA/CHMP/CVMP/3Rs/1094/2025), to be released for 4-months of public consultation. This revision of the reflection paper is to align with Regulation (EU) 2019/6 but also proposes relevant updates to scientific guidelines and regulatory provisions, which have 3Rs implications.
More information about the above-mentioned medicines (including their full indications), guidelines, reflection paper, and other documents, such as overviews on comments received during consultations, can be found below in “Related content”.