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View summaries of risk management plans (RMPs) for authorised medicines

The risk management plan (RMP) is a mandatory part of the marketing authorisation documents of a medicinal product and is updated throughout the entire life cycle of a medicinal product.

The published summary of the RMP (RMP Summa-ry) is part of the RMP and describes the safety profile of a drug and lists the measures that are planned for further investigation and monitoring of the risks as well as for their prevention or minimization.

By publishing the summaries of RMPs, the Federal Institute for Drugs and Medical Devices (BfArM) informs you as a user, for example as

  • Patientin und Patient
  • Nurse
  • Doctor,
  • Pharmacist or as a
  • Representative of the health care system.

The RMP summaries are published in German and English on the portal for drug information of the Federal Government and the Länder (online platform PharmNet.Bund). On its website, the BfArM publishes a monthly updated list of preparations for which an RMP summary has already been posted in PharmNet.Bund.

The RMP summaries supplement the summaries of public assessment reports (PAR) on medicinal products as well as the package leaflets and product information, which are also publicly available in PharmNet.Bund.

Process flow

  • Open the online platform PharmNet.Bund.
  • Click on "Drug Information System" and then on "Research".
  • Accept the declaration of consent.
  • After entering the active ingredient or trade name you are looking for, you get to the documents of the RMP summary (German and English) under "Additional documents".


There are no prerequisites.

Which documents are required?

You do not have to submit any documents.

What are the fees?

There are no costs.

What deadlines do I have to pay attention to?

There is no deadline.

Processing duration

The BfArM publishes the RMP summaries promptly after authorisation of the corresponding medicinal products. Here, the priority of publication is on new approvals of original preparations. Thereafter, RMP summaries on generics (copycat preparations) are also taken into account for publication.

Applications / forms

Forms available: No

Written form required: No

Informal application possible: No

Personal appearance required: No

Online services available: Yes


The publication of the RMPs is not an appealable decision.

What else should I know?

There are no clues or peculiarities.

Technically approved by

Federal Ministry of Health (BMG)


The text was automatically translated based on the German content.

Source: Serviceportal Niedersachsen (Portalverbund des Bundes und der Länder)