CVMP opinions on veterinary medicinal productsThe 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:Nobivac Bb, together with other national products (worksharing procedure)Porcilis AR-T DF – Porcilis ColiClos – Porcilis Porcoli Diluvac Forte (worksharing procedure)Maximum residue limitsThe 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) 2019/6Following two requests, the CVMP classified:A product (ATCvet classification: immunologicals for chickens (broilers) as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.A product (ATCvet classification: sensory organs) for dogs as not intended for a limited market and not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.Reflection papers, guidelinesAntimicrobialsThe 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.EfficacyThe 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”.
Brief
"On 17/01/2025, the European Medicines Agency (EMA) issued an update regarding Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP). The CVMP adopted positive opinions for several veterinary medicinal products, including vaccines against bluetongue virus and avian reovirus. Additionally, the committee concluded that certain chemical-unlike biological substances do not pose a risk to public health."
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Purpose:
The Committee for Medicinal Products for Veterinary Use (CVMP) adopted opinions on various veterinary medicinal products, including vaccines and antimicrobial substances. The primary purpose of these opinions is to ensure the safe and effective use of these products in food-producing animals.
Effects on Industry:
The adoption of positive opinions for marketing authorizations in exceptional circumstances for Bluevac-3, Syvazul BTV3, and Nobilis Multriva REOm will have a significant impact on the veterinary industry. These vaccines are intended to reduce viraemia, mortality, clinical signs, and lesions caused by bluetongue virus serotype 3 in sheep and cattle, and avian reovirus (ARV) genotypes 1 and 4 in chickens. The approval of these products will enable veterinarians to provide effective immunization against these diseases, ultimately benefiting the animal health sector.
The classification of chemical-unlike biological substances as not posing a risk to public health will also have implications for the industry. This decision will allow manufacturers to include these substances in veterinary medicinal products without requiring maximum residue limits (MRLs), which may streamline the development and marketing process.
Relevant Stakeholders:
- Veterinarians and animal health professionals
- Veterinary pharmaceutical companies, such as CZ Vaccines S.A.U., Laboratorios Syva, S.A., and Intervet International B.V.
- Regulatory authorities responsible for ensuring the safe and effective use of veterinary medicinal products
- Animal owners and breeders who rely on these products to maintain animal health
Next Steps:
The CVMP opinions will be used as a basis for further action by regulatory authorities. The approved marketing authorizations in exceptional circumstances will enable manufacturers to proceed with product development and marketing.
The classification of chemical-unlike biological substances as not posing a risk to public health may lead to changes in regulations and guidelines governing the use of these substances in veterinary medicinal products.
Any Other Relevant Information:
- The CVMP opinions and related documents are available on the EMA website for public access.
- Regulatory authorities will continue to monitor the safe and effective use of veterinary medicinal products, including those approved through exceptional circumstances marketing authorizations.
