Notification of supply bottlenecks for medicinal products for humans by the industry to the BfArM and publication of the supply bottleneck reports

Service Description

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 arise, 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".

Source: Zuständigkeitsfinder Thüringen (Linie6PLus)

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