Pharmaceuticals; notification of a supply shortage

If you, as a pharmaceutical company, experience supply shortages of certain human pharmaceuticals, you are required to report them.

Description

Prerequisites

Supply shortage notifications must be made for all drugs that meet the following criteria:

  • The active ingredient is on the "List of active ingredients to which the voluntary obligation to report supply shortages applies" of the Federal Institute for Drugs and Medical Devices. This list includes drugs that
    • Have been classified as supply-relevant,
    • are subject to the statutory obligation to report to hospitals,
    • have a market share of more than 25 percent
    • have a history of supply shortages, or
    • Are on the substitution exclusion list.

Procedure

To report supply shortages of supply-relevant human drugs, please proceed as follows:

  • Call up the "PharmNet.Bund" online portal for federal and state drug information.
  • Click on the "For companies" tab in the left-hand column and then on "Supply shortages".
  • First, apply for access data if you are not already registered.
  • Click on the "Delivery bottleneck reports" field and make all the necessary entries directly online.
  • Confirm the terms of use and submit the online notification.

The Federal Institute for Drugs and Medical Devices (BfArM) publishes the notification contents, which do not contain any service or business secrets, on the Internet.

Deadlines

Please report the bottleneck at least 6 months before it occurs.

Processing time

Your congestion report is usually available on the Institute's website the next business day after you submit the form.

Required documents

  • Required document/s

    • Delivery bottleneck message

Online procedures

Fees

  • There are no costs involved.

Remedy

These are voluntary notifications. There is no right of appeal.

Status:23.06.2022

Responsible for editing:Bundesministerium für Gesundheit

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