Approval and licensing of antimicrobials for use in animals, particularly food-producing animals, is a complex process that strives to ensure that products are effective and safe. To foster responsible use of antimicrobials and facilitate their safe use regulatory authorities may give specific guidance or apply specific restrictions of use. Pharmacovigilance is also applied in many countries and many jurisdictions also monitor antimicrobial sales and use and trends in antimicrobial resistance. This chapter describes the areas that are most commonly considered in pre-market assessment of a veterinary medicinal product in general and an antimicrobial product in particular. Besides risk management measures applied within the framework of marketing authorization for specific veterinary medicinal products, many authorities provide general guidance on how to use antimicrobials to minimize risks related to antimicrobial resistance. In order to track the current levels of antimicrobial use and antimicrobial resistance, monitoring programs are applied in many jurisdictions.