In the European Union, an effective and rigorous examination and registration system exists for placing any veterinary medicine or animal health product on the market. Dating back to 1965, the European Community Medicines Directive laid down three basic criteria on which decisions regarding marketing authorisation are based. Over the past 50 years, requirements in terms of these criteria have been updated continually in line with advances in scientific knowledge and risk management. Roxane Feller at AnimalhealthEurope discusses how Europe is at the crossroads for further updates to the rules governing the authorisation of animal medicines and medicated feed.