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

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

    Im PharmNet.Bund-Arzneimittel-Informationssystem sind neben administrativen Daten rund um die Zulassung von Arzneimitteln auch weiterführende Informationen wie Fach- und Gebrauchsinformationen kostenfrei recherchierbar.

Fees

  • There are no costs involved.

Remedy

The publication of the RMPs is not an appealable decision.

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

If you select a location under "Localization" the contact details of the responsible authority and, if applicable, locally valid information will be displayed.