AMIce 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 medicinal products information system AMIce was implemented at the DIMDI, now BfArM. The Competent Authorities of the Federal Government and the Laender work together with BfArM in order to improve and update this central information system.

AMIce - Public Part

The Database contains of four modules with different data about medicinal products. Basic data can be researched free of charge, detailed information about medicinal products can be accessed after purchasing a flat-fee.

Please note that at present the database is available only in German.

Module Medicinal Products

The module contains documents for German medicinal products 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.

Module Substances

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

Module 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.

Module Batch Release

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