BfArM - Federal Institute for Drugs and Medical Devices

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The Federal Institute for Drugs and Medical Devices (BfArM) provides an overview of current  shortages for human medicinal products (excluding vaccines) in Germany. The notifications are submitted by the pharmaceutical companies and are based on the voluntary commitment to report shortages of supply-relevant medicinal products declared within the “Pharmaceutical Dialogue of the Federal Government”.

A shortage notification is considered particularly necessary if the number of marketing authorisation holders, manufacturers responsible for batch release or manufacturers of a specific active substance falls below a critical threshold. Additionally, the voluntary commitment to report supply shortages applies to all active substances for which a supply shortage already occurred in the past.

A supply shortage is an interruption of a delivery in the usual scope that is expected to last longer than 2 weeks or a significantly increased demand that cannot be met adequately.

The BfArM publishes the data immediatly after the receipt of the shortage notification. Companies are requested to report a foreseeable supply shortage at least 6 months in advance and to notify the BfArM of unforeseen shortages immediately via the supply shortage online portal on the PharmNet.Bund Homepage – For Companies.