New Austrian Regulation on the stockpiling of human medicines

On April 21, 2025, a new regulation of the Austrian Federal Minister of Health on the stockpiling of human medicines came into effect. It aims to prevent drug shortages and ensure the uninterrupted supply of medicines to the Austrian population. The regulation will remain in force for three years.

Obligations for Marketing Authorization Holders (MAHs)

The regulation on the stockpiling of human medicines (“Verordnung betreffend die Bevorratung von Humanarzneispezialitäten”, BGBl II 161/2024) mandates that MAHs who distribute human medicinal products listed in the annex to the regulation must maintain adequate stock in Austria to meet patient demand for the duration specified in the annex.

Stockpile Requirements:

• The stockpile must be sufficient to cover four months of patient demand, calculated based on the quantities distributed by the MAH in the preceding calendar year.
• The measures will affect around 700 high-turnover pack sizes of human medicinal products that are important for ensuring the medical care of patients. These include painkillers, antibiotics, medicines for cold symptoms, but also preparations for chronic cardiovascular or lung diseases.

Third-Party Storage:

• If MAHs are unable to fulfill the stockpile requirements, they must arrange for an authorized third-party company to maintain the necessary stock. Only those companies that have a license to store medicinal products in accordance with the Austrian Medicines Act (AMG) are considered as authorized companies.
• A written agreement with the third party must be concluded and presented to the Austrian Federal Office for Safety in Health Care (BASG) upon request.
• Despite delegation, the MAH retains ultimate responsibility for the quantity to be stored on his behalf.

Review and Updates:

• The list of stockpile-obligated medicinal products will be reviewed and updated at least every two years.

Exceptions

The regulation provides for specific exceptions from stockpile obligations, including:

• A demand increased by at least 25 % compared to the calculated demand.
• Situations of force majeure or unforeseeable and uncontrollable events.
• Fulfillment of obligations under the European solidarity mechanism.
• Medicinal products subject to export bans imposed by the BASG.
• Minor and temporary stock shortages caused by normal inventory fluctuations.

Reporting Obligations via the eService portal of the BASG

MAHs are required to comply with specific reporting obligations via the eService portal of the BASG, including:

• Annual demand reports: to be filed by 31 March of each calendar year (by May 5 for the year 2025).
• Immediate notifications regarding the use of exemptions.

Are there any sanctions?

Non-compliance with the regulation may result in administrative fines of up to EUR 25,000, rising to EUR 50,000 for repeat violations.

What is recommended for MAHs?

To ensure compliance with the regulation, MAHs are advised to assess and maintain adequate stock levels as well as to engage authorized third-party companies if unable to meet the requirements.

The life sciences experts at CMS are happy to assist you with the implementation of the new obligations under the regulation and related issues.