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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 part of the RMP and describes the safety profile of a drug and lists the measures that are planned 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

  • Patientin und Patient
  • Caregiver
  • Doctor,
  • pharmacist or as a
  • Representatives of the health care system.

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

The RMP summaries complement the summaries of the Public Assessment Reports (PAR) on medicinal products, which are also publicly available on PharmNet.Bund, as well as the instructions for use and prescribing information.
 

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 do not 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 shortly after the approval of the corresponding medicinal products. The priority of the publication is on new approvals of original preparations. After that, RMP summaries of generics (generic 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 clues or special features.

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.

competent Bodies


Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Address: Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, Stadt
Remark: Head office Bonn
Timetable
Address: Waisenhausgasse 36-38a, 50676 Köln, Stadt
Remark: Head office Cologne
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Telephone: +49 228 99307-0
Fax: +49 228 99307-5207
www: Contact

Data protection information


Landkreis Emsland
Address: Ordeniederung 1 , 49716 Meppen
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Postal address: Post Office Box 15 62 , 49705 Meppen
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Telephone: 05931 44-0
Fax: 05931 44-3621
Transport Connection:
Station Haltestelle Kreishaus
Bus: 993

Building Access
elevator available, wheelchair-accessible
bank account:
recipients: Landkreis Emsland
bank: Emsländische Volksbank
BIC: GENODEF1LIG
IBAN: DE26266600600120050000
recipients: Landkreis Emsland
bank: Sparkasse Emsland
BIC: NOLADE21EMS
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recipients: Landkreis Emsland
bank: Postbank Hannover
BIC: PBNKDEFF250
IBAN: DE36250100300012132306

Ansprechpartner

Marc-André Burgdorf
responsible for:
Bernd Otten (Datenschutzbeauftragter)
Telephone: 05931 44-1605
Fax: 05931 44-391605
Room:
605
responsible for:

Landesbeauftragte für den Datenschutz Niedersachsen
Address: Prinzenstraße 5, 30159 Hannover
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Telephone: +49 511 12045-00
Fax: +49 511 12045-99

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