The Committee adopted by consensus a positive opinion for a marketing authorisation application for Icthiovac ERM from Laboratorios Hipra, S.A., a new vaccine for the active immunisation of Atlantic salmon fry to reduce mortality caused by serotype O1 (biotypes 1 and 2) and serotype O2 (biotype 1) of Yersinia ruckeri in freshwater.
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Poulvac Procerta HVT-IBD-ND from Zoetis Belgium, a new vaccine for the active immunisation of one day-old chickens and 18-19 day old embryonated chicken eggs to reduce mortality, clinical signs and lesions caused by Marek’s disease (MD) virus; reduce mortality, clinical signs and lesions caused by infectious bursal disease (IBD) virus; and reduce mortality and clinical signs caused by Newcastle disease (ND) virus.
The applicant submitted a Vaccine Platform Technology Master File (vPTMF) dossier simultaneously to the submission of the above-mentioned dossier for Poulvac Procerta HVT-IBD-ND, which was also certified by the Committee (see separate section below).
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Tolfenamic acid VMD (tolfenamic acid), from VMD N.V., a new product for the treatment of pneumonia and acute mastitis (cattle), adjunct in the treatment of metritis mastitis agalactia syndrome (pigs), symptomatic treatment of inflammatory and painful conditions of the osteoarticular and musculoskeletal systems and reduction of post-surgical pain (dogs) and treatment of febrile syndromes (cats).
The Committee adopted by consensus a positive opinion for a variation requiring assessment for Librela (bedinvetmab) to implement the outcome of the MAH’s signal management process. As a consequence of this variation, new information was added on adverse events in section 3.6 of the SPC and the corresponding section of the package leaflet was updated accordingly.
The Committee adopted by consensus positive opinions for:
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:
The Committee was informed of the formal notification from Ceva Santé Animale of their decision to withdraw the application for a grouped variation requiring assessment for Vectra 3D to add a new therapeutic indication and to update the pharmacodynamics section of the SPC. More information about this procedure at the current 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.
The Committee has issued a certificate for a vaccine platform technology master file (vPTMF). The certified HVT backbone vector vPTMF (Zoetis Belgium) is based on a turkey herpesvirus platform which is a new vaccine platform technology which has not yet been authorised in the EU. The vPTMF has been reviewed along with the full application for the above-mentioned new vaccine Poulvac Procerta HVT-IBD-ND. The vPTMF scheme is aimed at speeding up the development and approval of new veterinary vaccines in the EU.
The Committee adopted a scientific advice report for a request for initial advice on a pharmaceutical product for dogs.
Environmental Risk Assessment
The Committee adopted the revised guideline on assessing the environmental and human health risks of veterinary medicinal products in groundwater (EMA/CVMP/ERA/103555/2015). The amendments made are editorial in nature, to align the content of the documents with newly published/updated guidance (e.g. relevant OECD Test Guidelines) and to increase the clarity of text. No changes to the scientific content of the document have been made.
Immunologicals
The Committee adopted a concept paper for the revision of the guideline on the requirements for combined vaccines and associations of IVMPs (EMA/CVMP/IWP/188413/2024), to be released for a 3-month period of public consultation.
The Committee adopted a concept paper for the development of a guideline on quality aspects of mRNA vaccines for veterinary use (EMA/CVMP/IWP/189026/2024), to be released for a 3-month period of public consultation.
The Committee adopted a revised guideline on live recombinant vector vaccines for veterinary use (EMA/CVMP/IWP/390313/2023) following the close of the public consultation. This guideline has been developed to advise on the data to be presented in applications for a marketing authorisation of live recombinant vector vaccines, taking into account their particular properties. The revision will come into effect on 5 June 2025.
Antimicrobial resistance
The Committee adopted the scientific report on the impact on the use of azole fungicides, other than as human medicines, on the development of azole-resistant Aspergillus spp.
The Committee adopted the work plans for 2025 for:
The Committee adopted the 2025-2027 work plan for Quality Working Party (EMA/188820/2024).
The work plans will be published on the Agency’s website.
The Committee adopted VICH GL8(R) on Stability testing for medicated premixes for release for 5 months of public consultation.
The Committee adopted the consolidated 3-year work plan for the veterinary domain for 2025-2027 (EMA/CVMP/SPG/223141/2024), which highlights the priority areas for the Domain for the coming years.
The Committee appointed Dr K. Baptiste and Dr R. Carapeto García as co-opted members to complement its expertise in antimicrobial/antimicrobial resistance and in environmental risk assessment, respectively, for a 3-year mandate.
EMA will publish version 9.1 of the veterinary QRD product information on 10 December 2024. The new template will be available in all EU languages, with translations expected to be completed by the end of January 2025.
Among other changes, v.9.1 contains:
From 10 March 2025, applicants must use template version v.9.1 for new marketing authorisation applications. This version will not be implemented retroactively, and no re-assessment will be required for finalised applications of centrally authorised products already aligned with QRD template version 9.0. Any necessary corrections and updates can be made as part of an ongoing or future procedure that affects the product information, in consultation with the Agency.
To further assist applicants or marketing authorisation holders, EMA will publish an implementation plan for QRD template v.9.1, which will include transitional deadlines for products affected or unaffected by the new legal acts.
More information and documents will be publicly available on the Veterinary product information (QRD) templates landing page.
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”.