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 prescription-only medicinal product for human use listed in the annex to the ordinance on the market. The four-month 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 700 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 chronic 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 procuts 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". After positive feedback from BASG, the required quantity must be stockpiled immediately, but no later than 21 April 2025.

A temporary reduction of stock must be reported to BASG immediately via the eServices portal for 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 has to be notified. Temporary reduction of stock resulting from the usual circumstances of a rolling warehouse system are not subject to reporting.

The BASG is currently setting up the IT system in order to be able to provide the corresponding reporting options via the eServices portal. Guidance notes for the notification of the stockpiling demand and intended temporary reduction of stock will be made available at the end of 2024. It will be possible to submit both stockpiling demand notifications and reports of temporary reduction of stock using the eServices portal.

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 by March 31, 2025.

Link

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