German Medicinal Products Act

What does the German Medicinal Products Act regulate?

The Arzneimittelgesetz, or AMG for short, is divided into eighteen sections. § 2 defines what a medicinal product is, § 21 makes placing a product on the market subject to authorisation, § 43 regulates the pharmacy-only requirement, and § 48 the prescription requirement. § 55 defines the pharmacopoeia, §§ 62 et seq. govern pharmacovigilance, and §§ 84 et seq. contain the strict liability for medicinal product harm. The rules on clinical trials are closely intertwined with European law. Further provisions cover manufacturing licences, wholesale, labelling, and package leaflets. For pharmacists, the Act is therefore everyday law, not merely examination material.

What has changed recently?

The Pharmacy Supply Development Act (Apothekenversorgung-Weiterentwicklungsgesetz) was promulgated on 1 July 2026 and entered into force on 2 July 2026. In addition to the Social Code Book V, the Pharmacy Act, and the Pharmacy Operating Ordinance, it also amends the AMG and, through the new § 48a, introduces a narrowly confined possibility to supply chronically ill patients with a continuation of an ongoing therapy without a new prescription. The AMG is continuously adapted to EU law, meaning textbook versions quickly become outdated. For examinations, the version in force on the examination date is the one that counts, and the official online text is the most reliable source.

What does this mean for graduates from EU countries abroad?

Medicinal products law is only partially harmonised in the EU. Authorisation procedures and pharmacovigilance follow European requirements, while dispensing rules and pharmacy law remain national. Those who completed their degree in Bulgaria, Romania, Hungary, or the Baltic states know the European level, but must work through the German AMG afresh. In the knowledge examination (Kenntnisprüfung) and in the Third Section of the Pharmaceutical Examination, it forms, together with the Pharmacy Act and narcotics law, the core of the subject Special Legal Areas. The effort required is frequently underestimated, particularly since the specialist language has its own pitfalls.

Common misconceptions

The AMG does not regulate reimbursement by statutory health insurers; that is governed by Social Code Book V. Nor does it apply to medical devices, which are subject to their own European regulations. Narcotics law is also contained in a separate statute.