BfArM - Federal Institute for Drugs and Medical Devices

For public access

Administrative data concerning the authorisation of drugs as well as Summary of Product Characteristics (SPCs) and Patient Information Leaflets (PILs) can be found in the drug information system. Furthermore Information is available for a variety of subject areas.

Drug information system

The drug information system contains information on drugs from the national competent authorities in order to improve transparency and safety of drugs and to monitor the appropriate therapeutic use.

Clinical trials

The Database "Clinical Trials" contains information about authorised clinical trials with medicinal products conducted in Germany.

Pharmaceutical brokers

To ensure the reliability of the supply chain, the German Medical Products Act has been amended to extend medicine legislation to the entire supply chain. This now includes not only wholesale distributors, but also brokers who are involved in the sale or purchase of drugs.

Pharmaceutical wholesaler

Pharmaceutical wholesalers are legally bound by § 52a German Drug Law to purchase medicinal products from a manufacturer or a holder of a wholesale distribution authorisation only.

Non-interventional studies

When conducting non-interventional studies in Germany, notification obligations apply to the competent higher federal authority for „Anwendungsbeobachtungen“ and non-interventional post-authorisation safety studies.
Since the Third Act amending the regulations pertaining to medicinal products and other regulations came into force in August 2013, the higher federal authorities are obliged to publish notifications of „Anwendungsbeobachtungen“ throught an internet portal.