CHAPTER 5: Veterinary Medicinal Products

In the European Union, veterinary medicinal products are assessed for their safety prior to being issued with a marketing authorisation, and in this context, safety includes toxicological safety. The results of toxicity testing are used to assess the safety of a product for the animal patient, for the consumer of food derived from treated animals and for the users of animal medicines or to those indirectly exposed, including people stroking pets given topical treatments. The requirements for testing, and advice on the methods and approaches to testing, are set out in European Union guidance and other documents. This chapter discusses the major requirements and approaches for safety testing, paying particular regard to consumer and user safety.