Drug Information System AMIS

AMIS contains the approval data of the German drug regulatory authorities BfArM (Federal Institute for Drugs and Medical Devices), PEI ( Paul-Ehrlich-Institut - Federal Institute for Vaccines and Biomedicines) and BVL (Federal Agency for Consumer Protection and Food Safety).

According to § 67 a of the German Drug Act (Arzneimittelgesetz, AMG) the drug information system AMIS was implemented at the DIMDI. The Competent Authorities of the Federal Government and the Laender work together with the DIMDI in order to improve and update this central information system.

AMIS - Öffentlicher Teil (Public Part)

The Database contains of four modules with different data about drugs. Basic data can be researched free of charge, detailed information about drugs can be accessed after purchasing a flat-fee.
Please note that at present the database is available only in German.

Drugs

The module contains documents for German drugs with approved or expired marketing authorisation (since 30.04.1990) as well as the variation notifications referring to these documents. The information available is mainly administrative, for example trade name, marketing authorisation number or date of approval.

Substances

The module contains documents of active and other substances, for example adjuvants, impurities or not-marketable or controlled substances and includes further informations.

Terms of Substances

Terms of Substances verifiy the names of ingredients of medicinal products, that, according to the annex of the ordinance §10 in the database of the drug act (Arzneimittelgesetz, AMG), have to be used within the application for approval.

Batch Release

Extracts of tested batches, made by the the national competent authority, the Paul-Ehrlich-Institut are accessible in this database.