Veterinary Medicinal Antimicrobial Products
The development of veterinary medicinal antimicrobial products (VMAPs) has evolved to be one of the most complex tasks for product development for animals. This is mainly due to the fact that antimicrobial resistance is seen as one of the top relevant Problems of mankind globally and that the development of resistant Bacteria that are pathogenic for humans is linked to the use of antimicrobials as veterinary medicinal products in animals. This chapter in the well recognised 5th Edition of "Industrial Pharmaceutical Microbiology" provides an overview of the complex requirements to the development of VMAPs and tries to give guidance in this important area of Expertise, which is challenged by the political environment, the ever demanding requirements based on a benefit-risk approach and at the same time shrinking markets for use. In chapter 28 the author outlines the regulatory requirements in the European Union and gives comments on risks associated to the development of VMAPs.
DATE »
12.03.2019
AUTHORS »
Klaus Hellmann, KLIFOVET AG, Munich, Germany
PUBLISHED »
Chapter 28 in: Industrial Pharmaceutical Microbiology, Standards & Controls. Editor Tim Sandle, 5th Edition, 2019. Publ. Euromed Communications, Passfield, UK. ISBN 978-0-9956666-7-2