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.

Description

The Risk Management Plan (RMP) is a mandatory part of the marketing authorization documents of a medicinal product and is updated throughout the life cycle of a medicinal product.

The published summary of the RMP (RMP Summa-ry ) is a part of the RMP and describes the safety profile of a drug and lists the measures intended to further investigate and monitor the risks and to prevent or minimize them.

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

  • patient
  • nurse
  • Physician and doctor,
  • pharmacist or as a representative of the
  • Representative of the health care system.

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

The RMP summaries supplement the summaries of the public assessment reports (PAR) on medicinal products, which are also publicly available on PharmNet.Bund, as well as the directions for use and expert information.

Prerequisites

There are no prerequisites.

Procedure

  • 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".

Special notes

There are no clues or specifics.

Deadlines

There is no deadline.

Processing time

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.

Required documents

  • Required Documents

    Sie müssen keine Unterlagen einreichen.

Online procedures

  • 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.

Fees

  • There are no costs involved.

Legal bases

Remedy

The publication of the RMPs is not an appealable decision.

Links to more information

Status:20.08.2023

Responsible for editing:Bundesministerium für Gesundheit

  • Online transactions, Bavaria-wide
  • Online transactions, locally limited
  • Form, Bavaria-wide
  • Form, locally limited
  • Prefillable Form, Bavaria-wide
  • Legal bases, Bavaria-wide
  • Legal bases, locally limited
  • Fees, Bavaria-wide
  • Fees, locally limited
Information

Responsible for you

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