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View summaries of risk management plans (RMPs) for approved 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 RMP Summary is a part of the RMP and describes the safety profile of a drug and lists the measures envisaged to further investigate and monitor the risks and to prevent or minimise 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

  • Patientin und Patient
  • Caregiver
  • Doctor,
  • pharmacist or pharmacist
  • Representatives of the health sector.

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. On its website, the BfArM publishes a monthly updated list of preparations for which an RMP summary has already been published in the PharmNet.Bund.

The RMP summaries supplement the summaries of the public assessment reports (PAR) on medicinal products as well as the package information and prescribing 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 informed consent.
  • After entering the active ingredient or trade name you are looking for, you will be taken to the documents of the RMP summary (German and English) under "Additional documents".
     

Requirements

There are no prerequisites.

Which documents are required?

You don't need 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 the approval of the corresponding medicinal products. Here, the priority of publication is on new approvals of originator products. Thereafter, RMP summaries of generic drugs (copycat drugs) will also be considered for publication.

Applications / forms

Forms available: No

Written form required: No

Informal application possible: No

Personal appearance required: No

Online services available: Yes

Appeal

The publication of the RMPs is not an appealable decision.

What else should I know?

There are no hints or specifics.

Technically approved by

Federal Ministry of Health (BMG)

Professionally released on

06.05.2022

Author

The text was automatically translated based on the German content.

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