What is the German Medicinal Products Act?

The German Medicinal Products Act, or Arzneimittelgesetz (AMG), is a central law governing medicines in Germany. It addresses matters including manufacture, authorization, supply, labeling and medicine safety. Medical devices generally have a separate legal framework.

The AMG operates alongside directly applicable EU law and other German legislation. These include European authorization and clinical-trial rules and Germany's Drug Advertising Act. The current statutory text is therefore the starting point for identifying particular obligations.

How do authorization and regulatory responsibilities fit together?

Medicines requiring marketing authorization need evidence of quality, efficacy and an acceptable benefit-risk balance. Authorization does not guarantee that a medicine works for every person or has no adverse effects.

Germany's BfArM and Paul-Ehrlich-Institut have different product responsibilities. For the centralized EU procedure, EMA performs the scientific assessment and the European Commission grants the authorization. National, decentralized and mutual-recognition procedures also exist. Not every medicine is authorized exclusively by BfArM.

Which documents matter for communication?

The summary of product characteristics, package leaflet and labeling describe the approved properties and conditions of use. Marketing teams need the current version applicable to the relevant country. A new study or foreign authorization does not automatically extend an indication approved in Germany.

Clinical studies and continuing safety monitoring can generate new findings. Changes enter product information through the appropriate regulatory processes. A company's own patient brochure does not replace the authorized package leaflet.

What does this mean for marketing and field teams?

The AMG includes requirements concerning pharmaceutical representatives' knowledge and duties. Advertising must additionally satisfy the HWG and competition law. A marketing authorization therefore does not approve every promotional claim or communication channel.

In practice, companies should align product information, promotional materials and training. Reports of suspected adverse reactions must reach the responsible pharmacovigilance function. Disease education and promotional product communication each require an appropriate audience and content assessment.

Conclusion: Connect product status and communication

The AMG is an important part of the medicines framework. For marketing teams, the current authorization, reliable product information and established safety processes are particularly relevant. Coordination with Regulatory Affairs, Medical and pharmacovigilance helps keep statements consistent and traceable.