German Medicines Act (AMG)
The German Medicines Act (AMG) came into force in 1976 and provides the legal basis for the production, approval, distribution and continuous monitoring of medicines in Germany. The AMG obliges pharmaceutical companies, physicians and pharmacies to strictly comply with the prescribed prescription obligations and to properly inform patients about the content, effect and side effects of the drugs. In addition to the legal foundations, approval procedures and requirements, as well as registration and definitions for medicinal products are prescribed and defined, rules on packaging and package inserts are laid down, and evidence is demanded from drug manufacturers that disclose information on production, quality and efficacy. Furthermore, the AMG regulates imports and exports, liability for damage to medicinal products, and lays down the rules on penalties and fines in the event of violations of the Medicines Act.