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

According to the Ordinance on Stockpiling of Medicinal Products for Human Use (Federal Law Gazette II No. 161/2024), all marketing authorisation holders must stockpile sufficient quantities by April 21, 2025 in Austria if they place a medicinal product for human use listed in the annex to the ordinance on the market. The four-months demand throughout Austria must be transferred to stock and is calculated from the total number of packs dispensed per PIP code in the entire previous calendar year. About 600 high-turnover pack sizes of medicinal products for human use are affected that are important for ensuring medical care for patients and include painkillers, antibiotics, medicines for cold symptoms, but also preparations for cardiovascular or pulmonary diseases. In the event of a shortage, the patients’ needs in Austria can thus be covered for a time by falling below the reserve. 

If marketing authorisation holders are unable to stockpile due to a lack of or insufficient storage capacity in Austria, they must contract an authorised company to stockpile domestically. 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 will be notified in writing via the eServices portal by the Austrian Federal Office for Safety in Health Care (BASG) that a stockpiling demand notification must be submitted for the medicinal products listed in the annex. This must be done annually, by 31 March of each calendar year at the latest, using the application eServices "Authorisation and Lifecycle of Medicinal Products". For 2025, in which the Ordinance on Stockpiling of Medicinal Products for Human Use comes into force, marketing authorisation holders must submit their stockpiling demand notification within 14 days from 21 April 2025. As of April 21, 2025, the required quantity must be stockpiled by the marketing authorisation holder.

A temporary reduction of stock is only permitted due to the exceptions mentioned in the ordinance and must be reported to the BASG via the eServices portal immediately for the following reasons:

• an increased demand of at least 25% compared to the calculated demand pursuant to Section 2 (2) of the Ordinance,
• force majeure or other unforeseeable events or
• to fulfill the European solidarity mechanism

The amount of the temporary reduction of stock, the expected duration and all documents to enable BASG to assess the issue must be notified. Minor temporary reductions of stock resulting from the usual circumstances of a rolling warehouse system are not subject to reporting.

Reporting is provided via the eServices portal. It is possible to submit both stockpiling demand notifications and reports of temporary reduction of stock using the eServices portal. Guidance notes are available since December 10, 2024. 

As the ordinance was published on June 20, 2024 with a transitional period of ten months and will therefore enter into force on April 21, 2025, the stockpiling demand notification must be submitted for 2025 from April 21, 2025 within 14 days.

Link

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