Regulatory requirements for VMPs in the EU with special focus on efficacy

The regulatory requirements for obtaining a marketing authorisation for Veterinary Medicinal Products (VMP) in the European Union (EU) are one of the strictest requirements globally. An introduction to the value chain of veterinary medicinal product development will be provided to understand the complexity of the data required and administrative burden to be handled in order to launch a new product on the EU market. The regulatory environment for VMPs and pathways for VMPs to the EU market will be given: national, mutual recognition procedures (MRP), decentralised procedures (DCP) and the centralised procedure (CP) will be explained as well as the role of different European authorities and committees at the European Medicines Agency (EMA) will be explained. A special focus will be given on efficacy testing and the generation of clinically relevant and statistically proven data required to support indications for VMPs. Finally, the legal requirements will be detailed to place a new and independent pharmaceutical business in the EU and how to enter this second largest market in the world.