Inden et humanmedicinsk lægemiddel markedsføres i en eller flere medlemsstater, skal det normalt have været underkastet omfattende undersøgelser, herunder prækliniske og kliniske forsøg, for at garantere, at det er sikkert, af høj kvalitet og effektivt til brug i målgruppen.
Before a medicinal product for human use is placed on the market in one or more Member States, it generally has to have undergone extensive studies, including pre-clinical tests and clinical trials, to ensure that it is safe, of high quality and effective for use in the target population.