Data provision medicine shortages
Since February 1, 2018, marketing authorisation holders and their authorised representatives have to submit medicine shortages electronically by using the application eService "Marketing Authorisation & Lifecycle Management of Medicines".
Medicine shortages are published on the „Shortages catalouge“ on the actual date of beginning of the shortage.
Marketing authorisation holders and their authorised representatives have to submit medicine shortages because of the regulation on ensuring the provision of medicinal products, that enters into force as from April 1, 2020, and because of the "Arzneimittelbetriebsordnung 2009". They are now obliged to report any restriction in supply of prescription-only human medicinal products using the eService.
The notification of a shortage affecting veterinary medicinal products and over-the-counter medicinal products is voluntary, if it is not subject to notification in accordance with the "Arzneimittelbetriebsordnung 2009".
Since December 10, 2020, the BASG has also been offering the contents of the "Shortages catalogue", including information on parallelexport bans, in machine-readable form (XML).
In principle, the data export contains all shortages notifications that are also displayed in the „Shortages catalouge“. Not included are those notifications for which a resupply date has already been entered by the distributor for all affected packages and this resupply date has already been reached.
This means that pack sizes of a reported proprietary medicinal product that are reported as "not available", "restricted availability", "available acc. to § 4 (1)" or "available" will be made available in the XML as long as the report has not been completed by reavailability of all packs concerned. Please pay attention to the respective status of the packages when processing the data.
To simplify the processing of the reports, the provision is grouped according to PIP codes.
A provision of REST-based API retrieval options is already being planned and is expected to be completed from Q2/2022.
The data file is created daily (between 0:00 and 4:00 am) and made available on the BASG website under "Data provision medicine shortages".
XML schema: Contents and description of the export data
Designation of the data contents
Day and timestamp of the creation of the export file
|MD5sum||MD5 sum of the packs. Used to identify changes|
|Pack size information|
Unit of pack size
Container of pack size
Description of pack size
|Status of the affected pack size. The following values are transmitted: not available, limited available, available according to §4 (1)*, available|
|Beginn_Vertriebseinschraenkung||Beginning of the shortage of the pack size|
|Datum_voraussichtliche_Wiederbelieferung||Expected supply of the pack size (if provided by the notifier)|
Notification information -
Name of the notifying company
Date of report
Last modification date
Information letter to healthcare professionals (yes/no)
Legal basis of the notification
Important BASG-information (optional)
|Information of the medicinal product per pack size|
Marketing authorisation number
Name of the medicinal product
Parallelexport ban (yes/no)
Marketing authorisation holder
Telephone number of marketing authorisation holder
Reason of the shortage