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
As a pharmaceutical company, you are required to report supply shortages of certain human pharmaceuticals to the Federal Institute for Drugs and Medical Devices (BfArM). The notifications are published in a list of medicinal products currently in short supply on the Institute's website. Pharmaceutical manufacturers have committed themselves to this reporting as part of the "Pharmadialoge," a series of dialogs between the German government and the pharmaceutical industry.
The obligation to report supply bottlenecks does not apply to all human medicines in Germany, but in particular to those on the BfArM list - "List of active substances to which the voluntary obligation to report supply bottlenecks applies" - or which have a high market share. Particularly relevant are reports on drugs that are classified as supply-relevant and for which there are only a few marketing authorization holders, final-release manufacturers or active ingredient manufacturers. Supply shortages of vaccines must be reported to the Paul Ehrlich Institute.
A supply bottleneck occurs when a drug cannot be supplied for more than 2 weeks or not to the usual extent. Supply bottlenecks can occur, for example, due to production problems or due to the fact that demand on the market exceeds supply at short notice.
Please report supply bottlenecks of human medicinal products to the BfArM via the online portal "PharmNet.Bund".
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.
Remedy
These are voluntary notifications. There is no right of appeal.
Links to more information
Status: 23.06.2022
Responsible for editing: Bundesministerium für Gesundheit
- Online transactions, Bavaria-wide
- Online transactions, locally limited
- Prefillable Form, Bavaria-wide
- Legal bases, Bavaria-wide
- Legal bases, locally limited
- Fees, Bavaria-wide
- Fees, locally limited
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