Pharmaceuticals; notification of a supply shortage

If you, as a pharmaceutical company, identify supply shortages of certain medicinal products for human use, you are obliged to report them.

PharmNet.Bund
Drug data from the Federal Institute for Drugs and Medical Devices is made available to the public in a transparent manner via the "PharmNet.Bund" portal. Authorities and pharmaceutical companies can find applications for the transmission, authorization and registration of medicinal product data.

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As a pharmaceutical company, you are obliged to report supply shortages of certain medicinal products for human use to the Federal Institute for Drugs and Medical Devices (BfArM). The reports are published in a list of medicines currently in short supply on the Institute's website. Drug manufacturers have committed themselves to this notification as part of the "Pharmadialoge", a series of dialogs between the federal government and the pharmaceutical industry.

The obligation to report supply shortages does not apply to all medicinal products for human use in Germany, but in particular to those on the BfArM list - "List of active substances for which the voluntary obligation to report supply shortages applies" - or those with a high market share. Particularly relevant are reports on medicinal products 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 bottlenecks for vaccines must be reported to the Paul Ehrlich Institute.

A supply shortage occurs if a medicine cannot be supplied for more than 2 weeks or cannot be supplied in the usual quantities. Supply shortages can occur, for example, due to production problems or because demand on the market exceeds supply in the short term.

Please report supply shortages of human medicinal products to the BfArM via the online portal "PharmNet.Bund".

Notifications of supply shortages must be made for all medicines that meet the following criteria:

The active substance is on the Federal Institute for Drugs and Medical Devices' "List of active substances to which the voluntary obligation to report supply shortages applies". This list contains medicines that
- have been classified as relevant for supply,
- are subject to the statutory obligation to notify hospitals,
- have a market share of over 25 percent,
- have already had a supply shortage in the past, or
- are on the substitution exclusion list.

Required Documents
- Lieferengpassmeldung

Please proceed as follows to report supply shortages of supply-relevant human medicinal products:

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

The Federal Institute for Drugs and Medical Devices (BfArM) publishes the contents of the notification, which do not contain any official or business secrets, on the Internet (https://anwendungen.pharmnet-bund.de/lieferengpassmeldungen/faces/public/meldungen.xhtml).