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

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 document/s

    You do not need to submit any documents.

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 for you.

Remedy

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

Status:25.02.2023

Responsible for editing:Bundesministerium für Gesundheit

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