Antiparasitic veterinary drugs: From the bench to the market crossing (carefully) the environment

Workshop aims

1.     Veterinary Medicines Regulation in Europe: current framework and regulatory agencies involved; types and classification and example of a dossier for authorisation

The aim of this session is to provide an overview of the current rules on the authorisation and use of veterinary medicines in the European Union and the marketing authorisation routes. The role of the European Medicines Agency (EMA) and the Spanish Agency of Medicines and Medical Devices (AEMPS) will be discussed.

The different types and classification of Veterinary Medicinal products (VMPs) according to Regulation (EU) 2019/6 will be described, including novel therapies. And also a summary of the structure and studies to be performed to build a dossier for marketing authorisation, with an example of one biological product

2.     We have a promising Veterinary medicines candidates under research, what’s next?

This session will be focused on the different mechanisms available at AEMPS and EMA levels to support the development of new VMPs, such as the Scientific Advice or the Innovation Task Force. Eligibility and requirements of VMPs intended for limited market and support to SMEs.

At Spanish (AEMPS) level: Informal/formal meetings, national and bi-national Scientific advice. Authorisation of investigational veterinary medicines and clinical trials will also be covered.

Medicines in the environment: European approach to medicines in the environment. Environmental Risk Assessment of veterinary medicines, current situation and prospects. Risks to the environment of veterinary medicines.