Pharmaceuticals; inspection of risk management plan summaries
On the federal and state drug information portal, you can view summaries of risk management plans, as a supplement to technical and directions for use.
There are no prerequisites.
- Open the PharmNet.Bund online platform.
- Click on "Drug information system" and then on "Search".
- Accept the declaration of consent.
- After entering the active ingredient or trade name you are looking for, you will be taken to the RMP summary documents (German and English) under "Additional documents".
There are no clues or specifics.
There is no deadline.
The BfArM publishes the RMP summaries promptly after approval of the corresponding drugs. Priority for publication is given to new approvals of originator products. Subsequently, RMP summaries for generic drugs (imitation drugs) are also considered for publication.
PharmNet.Bund - Arzneimittel-Informationssystem
In the PharmNet.Bund drug information system, in addition to administrative data relating to the approval of drugs, further information such as technical information and directions for use can also be searched free of charge.
The publication of the RMPs is not an appealable decision.
Links to more information
Responsible for editing:Bundesministerium für Gesundheit
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