About
Veterinary Marketing Authorisation (MAA) and Variations (MAV) in the EU: Regulatory Requirements and Best Practices
The European regulatory framework for veterinary medicinal products requires strict compliance with pre- and post-market procedures to ensure product safety, quality, and efficacy.
The process of obtaining a Veterinary Marketing Authorisation (MAA) involves compiling a detailed dossier covering clinical and safety documentation. Additionally, any changes to authorised veterinary medicinal products must adhere to specific variation procedures under EU regulations.
This interactive training course provides a structured approach to understanding the MAA dossier requirements, focusing on clinical and safety documentation, and offers insights into key MAV processes, including Variations Not Requiring Assessment (VNRA) and Variations Requiring Assessment (VRA).
Participants will gain hands-on experience in preparing critical regulatory documents and best practices for managing variations efficiently.
This course is beneficial for regulatory professionals seeking a deeper understanding of EU veterinary medicinal product authorisation and variation management.
Programme
Veterinary Marketing Authorisation (MAA) in the EU
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- Structure of the MAA dossier for veterinary medicinal products
- Key documentation: Detailed and Critical Summaries (DACS) – Efficacy & Safety, User Risk Assessment (URA)
- Practical session: Gathering and preparing clinical and safety documentation with examples
Veterinary Marketing Authorisation Variations (MAV) in the EU
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- New EU legislation
- Variations Not Requiring Assessment (VNRA)
- Technical grouping
- Consequential VNRAs
- UPD submission of VNRA
- Variations Requiring Assessment (VRA)
- Grouping and Work-sharing
Regulatory specialists, Veterinary Medical Advisors and personnel working for organisations operating within the European Union with marketing authorisation for veterinary products.
Professionals working in human regulatory affairs, who want to understand how variations are managed in the veterinary sector.
Participant experience
No experience required.
Interactive training, discussion and practical approach.
Lecturers
Staša Taferner, PhD
Staša holds a PhD in Biomedical Sciences from University College London. She began her career as a Regulatory Affairs Manager at Krka, d.d., Novo mesto, specialising in initial marketing authorisations and lifecycle maintenance for both veterinary and human medicinal products in the EU and UK. After Krka, she moved to Universal Diagnostics, where she worked on Class C in vitro diagnostic devices (IVDs). She then joined Billev Pharma East, where she continues to work in regulatory affairs across medicinal products and medical devices. Her work spans a broad range of regulatory activities, with a strong focus on EU markets.
Online Training – 2 modules
Module 1 | 18 May 2026 from 2:30 pm to 5:30 pm CEST
Module 2 | 20 May 2026 from 2:30 pm to 5:30 pm CEST
Some days before the online training you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 690,00* until 27/04/2026
Ordinary: € 890,00*
Freelance – Individual – Academy – Public Administration: € 490,00*
* for Italian companies: +22% VAT
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Register
Roberta Alberti
Events & Training Manager
At the end of the training, you will be able to
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.