Veterinary medicinal product authorisation
This seminar takes you step by step through the development and regulatory authorisation of a veterinary medicinal product, from candidate substance to approved product. Through practical examples, you will learn about regulatory requirements, the key components of an application dossier and the authorities involved.
Seminar content
- Clinical trial fundamentals: veterinary and human medicine
- Regulation (EU) 2019/6 and the current German Veterinary Medicinal Products Act (TAMG)
- The regulatory framework for veterinary medicinal products since 2022
- Authorisation requirements and exemptions
- Medicinal product quality
- User safety
- Target animal safety
- Ecotoxicology
- NOAEL, ADI and MRL; residue assessment
- Relevant institutions and authorities in Germany and at EU level
- VICH and ICH guidelines
- National and European authorisation procedures; structure and content of the application dossier
- Variations and line extensions
Current examples also show why applications may fail, how risks and new findings are communicated, and which factors affect marketing and pricing after authorisation. You will also see how veterinary and human medicinal products differ.
Current regulatory framework
Since 28 January 2022, Regulation (EU) 2019/6 reorganised the European legal framework for veterinary medicinal products. The aims include improving availability, encouraging innovation, reducing unnecessary administrative burdens and strengthening action against antimicrobial resistance. In Germany, the EU regulation is supplemented in particular by the Veterinary Medicinal Products Act (TAMG). The seminar explains how these rules work together and what they mean in practice for the development, authorisation and lifecycle of a veterinary medicinal product.
Current challenges
- Availability of veterinary medicinal products, particularly in smaller markets and for less common animal species
- Antimicrobial resistance and the responsible use of antibiotics
- Developing alternatives to antibiotics and new prevention strategies
- New vaccines, diagnostics and innovative therapies
- The growing role of environmental safety and sustainability
- Emerging disease risks and changing pathogen profiles
- Closer collaboration between researchers, authorities and the pharmaceutical industry
This seminar gives you a structured overview of the full regulatory pathway for a veterinary medicinal product and shows how development, clinical trials, authorisation and monitoring fit together. You will also explore different career paths and assess which area of regulatory affairs best matches your interests.