The Committee adopted by consensus a positive opinion for a variation requiring assessment for Solensia (frunevetmab) to implement the outcome of the MAH’s signal management process, to include “skin disorders” as a rare adverse event. In addition, the MAH included some editorial changes in the Summary or Product Characteristics (SPC) section 10 – Classification of Veterinary Medicinal Products and package leaflet sections 7 - Adverse events and 15 Date on which the package leaflet was last revised, linked to the QRD template version 9.0.
The Committee adopted by consensus a positive opinion for a grouped variation requiring assessment for Frontpro (afoxolaner) to add a new therapeutic indication for the treatment of tick infestations with Ixodes hexagonus and align the wording of the indications for use with applicable CVMP guidelines, as well as to allow the use of the product in breeding, pregnant and lactating female dogs, and to align the product information with version 9.0 of the QRD template.
The Committee adopted by consensus positive opinions for variation requiring assessment applications concerning quality-related changes for:
The Committee concluded the procedure for Procactive 300 mg/ml suspension for injection for cattle, sheep and pigs (procaine benzylpenicillin) from Laboratorios Syva, S.A.U. The European Commission requested clarifications from the Committee under Article 54(8) of Regulation (EU) 2019/6 on a variation requiring assessment, due to lack of consensus between Member States in the CMDv review procedure on grounds of environmental safety. The CVMP, having considered the request by the European Commission and all available data, concluded, by majority, that the restriction of the use of Procactive 300 mg/ml suspension for injection to pigs weighing 25kg or less could be removed.
The Committee adopted two scientific advice reports further to requests for one initial and one follow-up advice for pharmaceutical products for dogs.
Antimicrobial resistance
The Committee adopted a questionnaire to stakeholders in the context of the CVMP reflection paper on dose review and adjustment of established veterinary antibiotics (EMA/CVMP/849775/2017) and the action included in the CVMP Work Plan. The objective of the questionnaire is to follow up the recommendations made in the reflection paper in order to establish a list of priority candidate products for review and potential adjustment of dosage regimens.
Efficacy
The Committee adopted a revised guideline on the conduct of pharmacokinetic studies in target animal species (EMA/CVMP/EWP/133/1999-Rev.1) following the close of the public consultation. The guideline has been revised to address scientific developments in the field in recent years and considerations regarding 3Rs principles and animal welfare. The comments received during the consultation procedure were taken into account for the revision of the guideline.
Pharmacovigilance
The Committee adopted a revised guideline on the calculation of dose factor to be submitted to the Union Product Database (UPD) (EMA/CVMP/PhVWP/399363/2023) following the close of the public consultation. This guideline has been developed to provide specific guidance on the considerations and calculations related to the dose factor which, alongside the submission of the yearly sales data, will allow the calculation and publication of the yearly reported incidences of adverse reactions for each veterinary medicinal product. The comments received during the consultation procedure were taken into account for the revision of the guideline.
The Committee adopted a revised questions and answers (Q&A) document on describing adverse events in the product information SPC and package leaflet). Questions 5 and 11 were updated, respectively, to include clarification of data sources to refer to when updating older product information where the established adverse event frequency categories were not used and further guidance is included on the tabular format for adverse events particularly for multiple target species.
Benefit-risk
The Committee adopted a revision to the guideline on the evaluation of the benefit-risk balance of veterinary medicinal products for release for a 6-month period of public consultation (EMA/CVMP/248499/2007 – Rev.1). 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 in the pre- and post-authorisation assessment of veterinary medicinal products.
The Committee adopted the Scientific advice to the European Commission on the implementing measures under Article 93(2) of Regulation (EU) 2019/6 as regards the GMP for veterinary medicinal products and active substances used as starting materials.
The Committee re-elected Boris Kolar as vice-chair of the ERAWP for a further 3-year mandate.
The Committee elected Manuela Leitner and Paul McNeill as new members of the SAWP-V.
The Committee adopted the CVMP work plan for 2024 (EMA/CVMP/475891/2023).
The Committee endorsed a revised guidance document on Quick Response (QR) codes in the product information of veterinary medicinal products. The guidance is applicable to the labelling and/or package leaflet of veterinary medicinal products authorised via centralised, decentralised and national procedures.
Quick Response (QR) codes in the labelling and/or package leaflet of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised procedures (DCP) and national procedures
The updated guidance reflects alignment with Regulation (EU) 2019/6, and flow-charts have been included to improve visual clarity of the process for requesting a QR code. Furthermore, sections of the guidance have been updated based on recent practical experience.
It is important to emphasise that this update has no impact on already submitted QR codes requests, or already approved QR codes.
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”.