According to § 4 para. 1 of the Ordinance on Stockpiling of Medicinal Products for Human Use, marketing authorisation holders are required to submit two notifications:

1. Annual stockpiling demand notification:
   By 31 March of each calendar year, the four-month demand must be reported via the BASG eServices portal. For 2025, the stockpiling demand notification must be submitted from April 21, within a period of 14 days.
2. Notification of the temporary reduction of stock:
   Any planned reduction of stock pursuant to § 3 para. 1 no. 1, 2, or 6 Ordinance on Stockpiling of Medicinal Products for Human Use, including the extent and expected duration, must be reported immediately via the eServices portal.
    

To submit notifications regarding stockpiling, authorisations in the eServices portal "Authorisation and Lifecycle ASP" are required, which are typically granted during the marketing authorisation or lifecycle process.
The following organisations are authorised to submit notifications:

• "Holder" of the affected medicinal product (marketing authorisation holder)
• "Authorised representative according to the marketing authorisation procedure" of the affected medicinal product (according to the authorisation).
   

Stockpiling demand notifications and notifications of temporary reduction of stock must be submitted exclusively via the eServices portal “Authorisation and Lifecycle ASP.” The BASG will notify the concerned marketing authorisation holders directly once it is possible to submit notifications via the portal. Notifications that deviate from this procedure cannot be accepted due to the mandatory electronic submission requirements under the Electronic Ordinance on Submissions 2011 (EEVO 2011).

The fee is based on the current regulation of fees and is charged per PIP code. The one-time fee per PIP code per calendar year covers both the stockpiling demand notification and the notification of the temporary reduction of stock for the respective calendar year and is collected after the completed stockpiling demand procedure. Administrative costs incurred due to the notification are considered additional costs pursuant to § 94k of the Austrian Medicines Act, as amended. Information on submitting a request will be provided in due course.

Marketing authorisation holders affected by the Ordinance on Stockpiling of Medicinal Products for Human Use will be notified via e-mail. The e-mail addresses registered in the eServices portal for the marketing authorisation holder and, if applicable, the authorised representative under the Lifecycle Management (LCM) subject area will be contacted, informing them that a stockpiling demand notification must be submitted for the medicinal products listed in the annex. This must be done by the marketing authorisation holder or the authorised representative by 31 March of each calendar year at the latest. For 2025, the stockpiling demand notification has to be submitted from April 21, within a period of 14 days. Please note that in the event of a revision of the annex, the BASG will not notify marketing authorisation holders if a medicinal product is no longer required to be stockpiled.
 

The stockpiling demand notification can be submitted for the first time starting in 2025, following notification from the BASG and must be submitted annually by March 31 at the latest. Submissions must be made exclusively through the eServices portal using the application "Authorisation and Lifecycle of Medicinal Products". For 2025, the stockpiling demand notification must be submitted from April 21, within a period of 14 days.
 

The stockpiling demand notification procedure will be initiated by the BASG for each medicinal product affected by the Ordinance on Stockpiling of Medicinal Products for Human Use. The marketing authorisation holder or the authorised representative according to the marketing authorisation procedure will be automatically notified by e-mail. The responsible marketing authorisation holders and authorised organisations shall then report the four-month demand, calculated from the total number of packs dispensed in the previous calendar year, per affected PIP code. After successfully submitting the stockpiling demand notification, a confirmation form will be sent to the email address registered in the eServices portal. The notification can be submitted exclusively via the eServices portal. Guidance notes for the reporting are available in both German and English.

The total sales of a pack size in the last calendar year in Austria must be divided by twelve and the result multiplied by four. Example: If 120,000 packs were sold in 2024, 40,000 packs of the relevant pack size must be stockpiled from April 21, 2025 (120,000/12)*4 = 40,000.

The procedure is not visible in the eServices portal until the BASG's review is complete. If the plausibility test is positive, marketing authorisation holders will be informed via the eServices portal and the e-mail addresses registered in the “lifecycle MP” topic area. In this case, the notification will appear under “Completed Applications”. If the plausibility test is negative, a notification will also be sent via the eServices portal and to the e-mail addresses registered in the portal. The procedure will reappear under “Current Applications” for further processing.

 

If the plausibility test is negative, a notification will be sent to both, the eServices portal and the e-mail address(es) registered in the eServices portal. The marketing authorisation holders are requested to explain their calculated four-months demand, upload any documents for re-examination and, if necessary, correct the demand. The procedure can still be found and edited under “Current Applications”. The document “Subsequent request after negative plausibility test” is available in the documents section of the eServices Portal.

The stockpiling demand notification is valid for the current calendar year.

 

Force majeure refers to an external, unavoidable, and unforeseeable event. This includes incidents such as fires in warehouses or at the manufacturer’s site and natural disasters like floods or earthquakes.
 

A rolling warehouse for medicinal products follows the FEFO principle ("First Expire, First Out"). This means that products with shorter expiry dates are sold first, while those with longer expiry dates are stored. This ensures that patients receive medicinal products with sufficient shelf life, while also maintaining an economical inventory to minimize the number of products that exceed their expiry dates.

No. If a medicinal product is subject to medicine shortages but no export ban has been imposed by the BASG, this indicates that sufficient alternative medicinal products are available to ensure supply. In this case, there is no legal basis for a temporary reduction of stock pursuant to § 3 para. 1 no. 3 of the Ordinance on Stockpiling of Medicinal Products for Human Use, which only applies to cases with an export ban. A temporary reduction of the medicinal product stock due to a medicine shortage in another country is not permitted either.
 

Yes. Once the reasons for the temporary reduction of stock pursuant to § 3 para. 1 of the Ordinance on Stockpiling of Medicinal Products for Human Use are no longer applicable, the required stock must be restored as soon as possible and the date of restoration of stock must be reported in the eServices portal. If another temporary reduction occurs within the same calendar year, this must be reported to the BASG via the eServices portal pursuant to § 4 para. 1 no. 2 of the Ordinance on Stockpiling of Medicinal Products for Human Use under the same procedure number. Guidance notes for the reporting are available in both German and English.
 

These functions can be found in the eServices portal under the "Lifecycle Management" (LCM) section. Guidance notes are available in both German and English.
 

Failure to comply with the stockpiling obligation constitutes an administrative offense. A complex and cost-intensive production does not exempt from the stockpiling requirement and does not qualify as an "unforeseeable or uncontrollable event" pursuant to § 3 para. 1 no. 2 of the Ordinance on Stockpiling of Medicinal Products for Human Use.

 

If the BASG becomes aware that the marketing authorisation holder is not or not fully complying with its obligations under the Ordinance on Stockpiling of Medicinal Products for Human Use, the BASG must initiate an investigation procedure by the authorities. Pursuant to § 84 para. 1 no. 23 of the Austrian Medicines Act, a violation of the Ordinance on Stockpiling of Medicinal Products for Human Use constitutes an administrative offence and is punishable by a fine of up to 25,000 Euro, or up to 50,000 Euro in the event of recurrence.
 

Authorised companies are those holding a permit for the storage of medicinal products according to § 63 para. 1 of the Austrian Medicines Act, particularly pharmaceutical wholesalers with an active authorisation and valid GMP/GDP certificate. To ensure proper enforcement, agreements between marketing authorisation holders and authorised companies regarding storage must be submitted to the BASG upon request. For information regarding authorisation and certification, refer to the information "Good Manufacturing / Distribution Practice (GMP/GDP)".

 

According to § 2 para. 1 of the Ordinance on Stockpiling of Medicinal Products for Human Use, medicinal products must be stored within Austria. If marketing authorisation holders are unable to stockpile due to insufficient storage capacity within Austria, an authorised company based in Austria must be contractually appointed to store the required quantity. Only operators with the appropriate authorisation for the storage of medicinal products in accordance with § 63 para. 1 of the Austrian Medicines Act are eligible.
 

No. Medicinal products that are no longer placed on the market, for example because their marketing authorisation has been withdrawn or their marketing has been revoked, no longer need to be stockpiled. In such cases, the BASG will not send a notification to submit a stockpiling demand notification.

The stockpiling obligation always applies to the current marketing authorisation holder. If the rights to a medicinal product are transferred to another authorised party through a legal transaction, the new holder inherits all rights and obligations related to the marketing authorisation of the medicinal product (see § 25 of the Austrian Medicines Act as amended).
 

According to § 94k of the Austrian Medicines Act, compensation for additional costs incurred in the previous calendar year can be requested from the BASG. This includes expenses for official fees as well as storage costs, up to a maximum of 5% of the manufacturer's sale price per medicinal product. Additionally, costs based on the 3-month Euribor rate plus 0.25 percentage points, calculated on the manufacturer's sale price per medicinal product, are eligible for reimbursement. Details on how to apply will be provided in due course.

 

The general principles of § 2 para. 1 of the Ordinance on Stockpiling of Medicinal Products for Human Use apply. Marketing authorisation holders are required to keep the medicinal products in sufficient quantities in Austria to meet the patient demand for the duration specified in the annex. In such cases, the stockpiling demand is determined based on the calculated demand rather than the sales volume of the previous calendar year.
 

Since the stockpiling demand notification always considers the entire previous calendar year, seasonal fluctuations are also accounted for. Furthermore, according to § 3 para. 2 of the Ordinance on Stockpiling of Medicinal Products for Human Use, minor temporary reductions of the medicinal product stock due to the usual circumstances of a rolling warehouse are permissible.
 

New registrations to receive access data can be requested on the BASG website in the section “Registration online services”. 
Access data will be sent to the applicant after successfully completing the registration process. 
After receiving the access data, the stockpiling demand notification can be performed in the eServices portal “Authorisation and Lifecycle of Medicinal Products”.
Further details for the registration are published on the BASG website in the section “Guidance notes” or in the guidance notes ”For the registration of companies/organisations”.

 

The Federal Office for Safety in Health Care (BASG), Traisengasse 5, 1200 Vienna, is responsible for enforcing the provisions of the Ordinance on Stockpiling of Medicinal Products for Human Use. For inquiries, please contact the BASG via e-mail at bevorratung@basg.gv.at.