Pharmaceuticals; inspection of published assessment reports.

On the portal for drug information of the federal government and the states, you can view public assessment reports with information on the approval decision of drugs, as a supplement to the expert information and directions for use.

Description

In the so-called public assessment reports (PAR), the Federal Institute for Drugs and Medical Devices (BfArM) informs users, for example

  • Physicians,
  • pharmacists and
  • other health care professionals.

The PARs contain information on medicinal products and medical devices concerning

  • quality,
  • efficacy,
  • safety or
  • risks, such as areas of application and possible side effects.

The PARs are intended to contain all essential information for the approval decision and are a supplement to the already publicly available expert information and information for use.

The assessment reports published by the BfArM relate to medicinal products for use in humans. They are published on the portal for drug information of the federal and state governments (online platform PharmNet.Bund).

You can view these assessment reports there at any time.

Prerequisites

There are no prerequisites.

Procedure

  • Open the PharmNet.Bund online platform.
  • Click on "Drug information system" and then on "Search".
  • After you have accepted the declaration of consent, you can search for drugs and also read the assessment reports.

Deadlines

You do not have to meet any deadlines.

Processing time

The BfArM publishes the PAR promptly after approval of the corresponding drugs. In the event of major changes to the marketing authorization, for example indication extensions, the BfArM publishes updates in a timely manner. The time period for preparation depends, among other things, on the complexity of the approved drug.

Required documents

  • Required Documents

    Sie müssen keine Unterlagen einreichen.

Fees

  • There are no costs for you.

Remedy

The publication of public assessment reports is not an appealable decision.

Status: 23.06.2022

Responsible for editing: Bundesministerium für Gesundheit

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  • Prefillable Form, Bavaria-wide
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  • Fees, Bavaria-wide
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Information

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