Through PharmNet.Bund.de an integrated, centralised drug information system of the Bund and the Laender develops iteratively. It provides access to the officially collated data available throughout Germany relating to the marketing authorisation/registration and supervision of medicinal products in Germany.
PharmNet.Bund.de is a cooperative project of the German regulatory authorities – Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)), the Paul-Ehrlich-Institut (PEI) and the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)) – together with the Robert Koch Institute (RKI) and the German Institute of Medical Documentation and Information (Deutsches Institut für Medizinische Dokumentation und Information (DIMDI)). The project will be implemented in close cooperation with the competent authorities of the Laender coordinated by the Central Authority of the Laender for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG)).
The PharmNet.Bund.de portal provides the public with information from the drug information system of the competent authorities. The information system contains administrative data concerning the authorisation of medicinal products as well as Summary of Product Characteristics (SPCs) and Patient Information Leaflets (PILs), Summaries of Public Assessment Reports or result reports of Clinical Trials.
"Online Variation Submission" is a sub-project of "Electronic Submission". It currently comprises the online entry of all national variation notifications and variations from the mutual recognition procedure and the decentralised BfArM procedure. The data of the other authorities will be completed consecutively. Access is restricted to the competent authorities and pharmaceutical companies as applicants.
Use of the PharmNet name is made possible through the friendly approval of Cerner Deutschland GmbH that - as a provider for healthcare information technology solutions - offers software solutions for pharmaceutical management in hospital pharmacies under this trademark. DIMDI and Cerner Deutschland GmbH are not involved in a business relationship.
Last modified: 5/20/15