The New GMP Implementing Regulations for Veterinary Medicinal Products and Related APIs - Online Training Recording
An Overview on the New EU Regulations 2025/2154 and 2025/2091
Course No. 23020
Speakers
Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Dr Peter Stilkenböhmer
Bela-Pharm
Two experienced speakers will present key content, interpretations and practical aspects of the new EU Regulations 2025/2154 and 2025/2091.
Target Group
The Training is addressed to:
Qualified Persons (QPs) and Responsible Persons for Veterinary Medicinal Products
QA/QC and Regulatory Affairs Professionals in the Veterinary and API Sector
Manufacturing and Production Managers, including Sterile Products
API Manufacturers, Suppliers, and Contract Manufacturers
Auditors in the field of Veterinary Medicinal Products
Companies and Individuals preparing for implementation of the New EU Veterinary GMP Regulations
Objectives
In this Recording, participants will:
Understand the EU's completed legal framework for veterinary medicinal products and related APIs
Identify what has changed and what remains the same under the new veterinary GMP regulations
Clarify the applicability of Q&As, MRAs, PIC/S and ICH in the new regulatory context
Understand the specific requirements for QP certification, sterile manufacturing and the Site Master File
Recognise potential national differences despite the existence of directly applicable EU regulations
Learn practical approaches for managing the transition and implementing the new requirements
Gain insight into typical challenges and best practices from examples of industry implementation
Background On 17 October 2025, the European Commission published two new GMP Implementing Regulations: (EU) 2025/2091 for veterinary medicinal products, and (EU) 2025/2154 for active substances used as starting materials in veterinary medicinal products. These regulations implement the requirements of Regulation (EU) 2019/6. These legally binding Regulations will take effect on 16 July 2026, replacing the former veterinary GMP provisions in EudraLex Volume 4 and establishing an independent regulatory framework for veterinary GMP.
Programme
New EU Regulations for Veterinary Medicinal Products & Related APIs
The veterinary medicinal legal framework is now complete – overview
Applicability of Q&As, MRAs, PIC/S, ICH
What is New, What Stayed Unchanged
The language – does it matter?
QP certification
Production of sterile veterinary medicinal products
Site Master File
National differences despite EU regulations?
Managing the Change - Practical Experience/Implementation – Examples
How to implement the new EU veterinary GMP requirements in practice
Key changes, challenges and solutions
Lessons learned from real-life implementation
Further Information
Technical Details To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your Needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
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