Veterinary Medicines Highlights – Issue 22

14th October 2025

Veterinary Medicines Highlights – Issue 22

Summary:

• Editorial Overview: Kristina Paterson, Head of Veterinary Regulatory Affairs and Referrals Service, reflects on the progress made in implementing Regulation (EU) 2019/6, noting a shift from intense guideline development to a more manageable pace. This transition allows the Committee for Medicinal Products for Veterinary Use (CVMP) to focus on new initiatives, including the Dosage Review and Adjustment of Selected Veterinary Antibiotics (ADRA) project. The first procedure, targeting amoxicillin dosage regimens for treating respiratory infections in pigs, is scheduled to commence at the October 2025 CVMP meeting.

• Regulatory Updates:

  • Updated QRD guidance has been published regarding the use of abbreviations and pictograms on veterinary medicinal product packaging.

  • New procedural advice has been issued on the publication of information concerning the withdrawal of marketing authorisations and variation applications for veterinary medicinal products, superseding the previous CVMP Reflection Paper (EMEA/CVMP/425558/2006).

  • Progress continues on the submission of G.I.18 variations for centrally authorised products (CAPs), with 191 products receiving a positive opinion to date, representing 77% of all CAPs concerned. Companies are reminded to submit their variations promptly ahead of the 29 January 2027 deadline.

• Pharmacovigilance Updates:

  • The Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) has been updated, including revised clinical terms, deprecated codes, and data-friendly files to support consistent pharmacovigilance reporting across the EU.

• Other News:

  • EMA invites veterinary companies with extensive medicinal product portfolios to apply for Portfolio and Technology Meetings (PTMs), with the submission deadline set for 14 November 2025.

  • A webinar on Application Programming Interfaces (APIs) for national competent authorities is scheduled for 6 November 2025, aiming to provide an overview of available APIs to the network.

  • The 5th Veterinary Big Data Stakeholder Forum is scheduled for 10 November 2025, focusing on real-world applications of big data and artificial intelligence (AI) in the veterinary medicinal regulatory domain.

  • Phase 2 of the Union Product Database (UPD) Data Quality Framework (DQF) is now live and accessible to national competent authorities.

  • A survey has been launched as part of the "Big Data in Veterinary Medicines Regulation" research project, led by Stichting Wageningen Research, targeting veterinary stakeholders.

• CVMP Statistics 2025: Detailed information can be found in the CVMP meeting highlights.

• Upcoming Events:

  • EMA roundtable with Small and Medium-sized Enterprise (SME) stakeholders on 17 October 2025.

  • UPD webinar for national competent authorities on APIs on 6 November 2025.

  • 5th Veterinary Big Data Stakeholder Forum on 10 November 2025.

  • EMA Veterinary Medicines Info Day 2026 on 12–13 March 2026; registration will open in December 2025.

• Ongoing Public Consultations:

  • Concept paper for the development of a reflection paper on the assessment of public health risks related to antimicrobial resistance acquired via the environment, resulting from the use of a veterinary medicinal product, open until 31 October 2025.

  • Concept paper on the need for revision of the note for guidance on quality aspects of pharmaceutical veterinary medicines for administration via drinking water, open until 31 October 2025.

Link: Veterinary Medicines Highlights – Issue 22

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