Information regarding the Ordinance on Stockpiling of Medicinal Products for Human Use

With the Ordinance on the Stockpiling of Human Medicinal Products (Federal Law Gazette II No. 161/2024), marketing authorisation holders have been required, since April 21, 2025, to maintain sufficient stock levels of selected human medicinal products. The specific pack sizes subject to stockpiling obligations are listed in the Annex to the Ordninance.
The stock to be maintained corresponds to the nationwide demand in Austria for a period of four months. This demand is calculated on the basis of the number of packs dispensed nationwide during the preceding calendar year, per PIP code. At present, the Ordinance covers approximately 400 high turnover pack sizes of human medicinal products that are of particular importance for ensuring the medical care of patients. These include, among others, analgesics, antibiotics, medicines for the treatment of cold symptoms, as well as products for cardiovascular and respiratory diseases. In the event of a shortage, a temporary reduction of stock level may therefore help to cover patient needs in Austria for a limited period.

If marketing authorisation holders are unable to fulfil the stockpiling obligation themselves due to a lack of, or insufficient, storage capacity within Austria, they must contractually engage an authorised company to store the required quantities in Austria. Authorised companies are only those having a Wholesale Dealer Authorisation (WDA) according to Section 63 (1) of the Austrian Medicines Act.

All marketing authorisation holders affected by the Ordinance are notified in writing by the Austrian Federal Office for Safety in Health Care (BASG) via the eServices Portal that a stockpiling demand notification must be submitted for the medicinal products listed in the Annex. This demand notification must be submitted annually, no later than 31 March of each calendar year, via the eServices "Authorisation and Lifecycle of Medicinal Products". 

A temporary reduction of stock level is permitted only for the reasons specified in the Ordinance. Where one of the following reasons applies, an immediate notification must be submitted to the BASG via the eServices Portal:

• an increase in demand of at least 25% compared with the calculated demand pursuant to Section 2(2) of the Ordinance;
• force majeure;
• other events that are unforeseeable or uncotrollable; or
• the fulfilment of the European solidarity mechanism.

The notification must specify both the extent of the reduction and its expected duration. In addition, all documentation necessary to enable the BASG to assess the stated reasons must be attached. Minor temporary reductions of stock resulting from the usual circumstances of a rolling inventory are not subject to notification. 
 

Appropriate reporting functions for both demand notifications and notifications of temporary reduction of stock are available via the eServices Portal. A corresponding guidance note is also available.
 

Link

Information of the Federal Ministry of Labour, Social Affairs, Health, Care and Consumer Protection on January 24, 2024: Erhöhte Arzneimittelbevorratung soll Medikamentenengpässe künftig verhindern