The Committee adopted by consensus a positive opinion for a marketing authorisation application for Carprofen Orion (carprofen), from Orion Corporation, a new generic product for dogs for alleviation of inflammation and pain in musculoskeletal and joint disorders and after surgical procedures, for perioperative alleviation of pain and inflammation especially in orthopaedic and soft tissue (including ocular) procedures; for cats for perioperative alleviation of pain.
The Committee adopted by consensus a positive opinion for two variations requiring assessment for MS-H Vaccine (Mycoplasma synoviae): to update the pharmaceutical dose form and route of administration from ocular use to oculonasal use to align with the update of the definition of the EDQM standard term, and to amend section 3.5. of the summary of product characteristics to strengthen the warnings and clarifications on how to diagnose M. synoviae-free birds and on the special precaution to avoid spreading of the vaccine strain.
The Committee adopted by consensus a positive opinion for a variation requiring assessment for Simparica Trio (sarolaner /moxidectin /pyrantel embonate) to add a new therapeutic indication for the treatment of the lungworm Angiostrongylus vasorum.
The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:
The Committee adopted by consensus a positive opinion for variations requiring assessment to align the product information with version 9.0 of the QRD template for:
The Committee has issued its first certificate for a vaccine platform technology master file (vPTMF). The certified Innovax vPTMF (Intervet International B.V.) is based on a turkey herpesvirus platform which is already used in several approved vaccines for chickens. The vPTMF scheme is aimed at speeding up the development and approval of new veterinary vaccines in the EU.
For more information, see:
Further to a request from the European Commission to assess the appropriateness of the “No MRL required” status of ketoprofen in bovine, porcine and Equidae, the Committee adopted by consensus a positive opinion recommending the establishment of numerical maximum residue limits for ketoprofen in all ruminants, porcine and Equidae.
The Committee adopted five scientific advice reports, further to four requests for an initial advice and one request for a follow-up advice, for three pharmaceutical, one immunological and one biological product. The target species were dogs (three products) and cats (two products).
Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
Following one request, the CVMP classified:
Quality
The Committee adopted a guideline on stability testing for variations for veterinary medicinal products (EMA/CVMP/QWP/515653/2023) and the overview of comments (EMA/CVMP/QWP/416589/2024) following the close of the public consultation. This document provides guidance on the stability data which have to be generated in order to support a variation to a marketing authorisation for veterinary medicinal products. The guideline applies to both variations not requiring assessment (VNRA) and variations requiring assessment (VRA).
The Committee adopted a revision of the guideline on the evaluation of the benefit-risk balance of veterinary medicinal products (EMA/CVMP/248499/2007 – Rev.1) and the overview of comments following the close of the public consultation (EMA/CVMP/307496/2024). This revised guideline will replace the 'Recommendation on the evaluation of the benefit-risk balance of veterinary medicinal products' and has been updated primarily to align with the regulatory and scientific framework provided by Regulation (EU) 2019/6, as well as to take account of experience gained over the years in the pre- and post-authorisation assessment of veterinary medicinal products.
The Committee adopted the updated English QRD template v.9.1. The main purpose of updating the QRD template to version 9.1 is to align with the requirements of the Commission Delegated Regulation for products for oral administration (Regulation (EU) 2024/1159), Commission Implementing Regulation adopting a list of abbreviations and pictograms (Regulation (EU) 2024/875) and Commission Implementing Regulation adopting uniform rules on the size of small immediate packaging (Regulation (EU) 2024/878). The template will be implemented once the translations in all EU languages are available.
The Committee also adopted the implementation plan following the release of an updated QRD template version 9.1 which will be published by the end of the year on the EMA and CMDv websites.
The Committee adopted the CVMP work plan for 2025 (EMA/CVMP/456565/2024).
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”.