Before a batch of medicine made in Germany may be sold, one named person must sign it off. The Medicines Act calls her die sachkundige Person, the qualified person. Die sachkundige Person nach § 14 ist dafür verantwortlich, dass jede Charge des Arzneimittels entsprechend den Vorschriften über den Verkehr mit Arzneimitteln hergestellt und geprüft wurde. She is responsible for making sure that each batch was made and tested according to the law on medicines. She must certify this for each batch in a running register before it goes on the market. Sometimes a batch is made in several stages or at other sites. The regulation on drug manufacturing then lets her use confirmations from other qualified persons. But sie ist für die Freigabe zum Inverkehrbringen der Charge insgesamt persönlich verantwortlich. She remains personally responsible for releasing the batch as a whole. Medicines may be placed on the market only after this release.