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On the portal for medicinal product information of the federal and state governments, you can view public assessment reports with information on the approval decision for medicinal products as a supplement to the information for healthcare professionals and package leaflets.
This form can be submitted electronically without signature (e.g. via a secure contact form or by e-mail) or in paper form to the responsible authority.
In the so-called public assessment reports (PAR), the Federal Institute for Drugs and Medical Devices (BfArM) informs users, for example
The PARs contain information on medicinal products and medical devices regarding
The PARs are intended to contain all essential information for the authorization decision and are a supplement to the already publicly available information for healthcare professionals and package leaflets.
The assessment reports published by the BfArM refer to medicinal products for human use. They are published on the portal for medicinal product information of the federal and state governments (online platform PharmNet.Bund).
You can view these assessment reports there at any time.
There are no prerequisites.
Sie müssen keine Unterlagen einreichen.
There are no costs for you.
You do not have to meet any deadlines.
The BfArM publishes the PAR promptly after authorization of the corresponding medicinal products. In the event of major changes to the authorization, for example indication extensions, the BfArM publishes updates promptly. The time required for preparation depends, among other things, on the complexity of the authorized medicinal product.
The publication of the public assessment reports does not constitute an appealable decision.