The New GMP Implementing Regulations for Veterinary Medicinal Products and Related APIs - Live Online Training
An Overview on the New EU Regulations 2025/2154 and 2025/2091
Wednesday, 6 May 2026 9 .00 - 12.30 h
Course No. 22705
Speakers
Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Dr Peter Stilkenböhmer
Bela-Pharm
In around three and a half hours, two experienced speakers will present key content, interpretations and practical aspects of the new EU Regulations 2025/2154 and 2025/2091. Participants will have the opportunity to ask their own questions and discuss them with the experts.
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 Live Online Training, 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
Question and Answer Session A live Q&A Session will give you the possibility to interact with the speakers and get answers to your Questions.
Further Information
Technical Requirements We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate plus VAT) ECA Members € 590 APIC Members € 690 Non-ECA Members € 690 EU GMP Inspectorates € 490 The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Contacts Questions regarding content: Ms Sarah Schmidt (Operations Director), +49(0)62 21 84 44 16, s.schmidt@concept-heidelberg.de Questions regarding organisation: Ms Sonja Nemec (Organisation Manager), +49(0)62 21 84 44 24, nemec@concept-heidelberg.de.
Date & Time
Wed, 06 May 2026, 9:00 – 12:30 h All times mentioned are CEST
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