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.
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 is provided on “Application for compensation for additional costs incurred due to stockpiling”.

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. 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 must be submitted annually by March 31 at the latest following notification from the BASG. Submissions must be made exclusively through the eServices portal using the application "Authorisation and Lifecycle of Medicinal Products". 
 

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 the successful submission of 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 for the sales figures from the previous year 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 holder is requested to substantiate the stated demand using pseudonymised, system-generated sales statistics or, if necessary, to 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.
 

According to § 4 (2) of the Ordinance on Stockpiling of Human Medicinal Products, if a reduction of stock is intended due to a mandatory reporting reason, a notification must be submitted immediately via the eServices portal.
The notification must include the reason, the extent and the expected duration of the reduction of stock. Additionally, all documents that enable the BASG to assess the reasons for the reduction of stock must be attached.

As soon as the marketing authorisation holder becomes aware that despite the reduction of stock a non-availability lasting more than two weeks or a limited availability lasting more than four weeks an additional medicine shortage notification must be submitted immediately in accordance with the regulation on ensuring the provision of medicinal products.
The publication of the notification will take place no earlier than on the day the shortage comes into effect. Should an export ban be imposed, it will likewise not take effect before that point in time.

The stock level to be specified in the medicine shortage notification refers to the total number of packs available to the Austrian population and therefore includes the remaining safety stock in accordance with the Ordinance on Stockpiling of Human Medicinal Products.
 

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 whose marketing authorisation has been withdrawn or whose marketing has been discontinued no longer need to be stockpiled. The marketing cessation must be reported to the BASG via the eServices portal four months in advance in accordance with § 21 (2) of the Austrian Medicines Act (AMG) as amended, and will be published in the Medicinal product index.

For the stockpiling demand procedure, this means: 

• If the date of the marketing cessation is prior to the start of the new stockpiling demand notification procedures at the beginning of the calendar year, no new procedure will be initiated and no notification will be issued by the BASG to the marketing authorisation holder. If, despite timely notification of the discontinuation of placing on the market, a request to submit a stockpiling demand notification is issued, please contact: bevorratung@basg.gv.at
• If the date of the marketing cessation is after the start of the new stockpiling demand notification procedures but before the end of the statutory reporting period, no stockpiling demand notification needs to be submitted.
• If the date of marketing cessation is after the end of the statutory reporting period, the medicinal product must be stockpiled until the actual date of marketing cessation. The annual stockpiling demand notification must be submitted to the BASG.

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).
 

Marketing authorisation holders who are obliged to stockpile medicinal products pursuant to Section 57a (2) of the Austrian Medicines Act (AMG) are entitled to receive compensation for the additional costs incurred as a result pursuant to Section 94k AMG upon application to the BASG. The additional costs are only those costs that exceed the costs incurred for normal stockpiling (to cover the needs of patients in Austria).

Of the additional costs, those for storage amounting to a maximum of 5% of the ex-factory price per medicinal product to be stockpiled (patient requirements for 4 months as stated in the notification of requirements to be submitted to the BASG) and costs amounting to the 3-month EURIBOR rate plus 0.25 percentage points, calculated on the ex-factory price per medicinal product to be stockpiled, will be reimbursed.

Information is provided on “Application for compensation for additional costs incurred due to stockpiling”.

 

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 “FAQ online Service” 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.