In depth
The main obligation stipulated by the ordinance applies to Marketing Authorization Holders (MAHs): MAHs who distribute a medicinal products for human use listed in the ordinance's annex that are actually placed on the market must, within the scope of their responsibility, keep a sufficient quantity of this product in stock in Austria to cover the needs of patients for a duration specified in the annex. The needs to be met are based on the quantity dispensed by the MAH in the previous calendar year.
There are currently approx. 700 medicinal products listed in the annex, and the duration to meet the needs of patients is currently set to four months for all listed medicinal products. Medicinal products requiring stockpiling, as per the annex, particularly include medicines containing the following active ingredients, among others:
- AMOXICILLIN
- AZITHROMYCIN
- BUDESONIDE
- CIPROFLOXACIN
- CLARITHROMYCIN
- DEXAMETHASONE
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- DOXYCYCLINE
- IBUPROFEN
- IMMUNOGLOBULIN
- PARACETAMOL
- SALBUTAMOL
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If MAHs are unable to fulfil their stockpiling obligation, they must ensure that the required quantity is kept in stock by an authorized undertaking. A written agreement on this must be made and presented to the Austrian Federal Office for Safety in Health Care (BASG) upon request.
At least every two years, the annex's list of medicinal products subject to mandatory stockpiling is reviewed to ensure that it is up to date.
Exceptions
There are some exceptions to the stockpiling obligation, e.g., if stockpiling is not possible due to force majeure or other unforeseeable or uncontrollable events. A further exception applies in relation to the fulfilment of the European solidarity mechanism and medicinal products for which an export ban has been imposed on by the BASG. In addition, minor shortfalls in the stock of medicinal products of short duration, which occur due to the usual circumstances of a rolling stock, are permissible.
Furthermore, regarding the stockpiling obligation, notification duties for MAHs apply vis-à-vis the BASG.
The ordinance will finally enter into force on 21 April 2025 and is then limited to a period of three years. Non-compliance with the ordinance can lead to administrative fines of up to EUR 25,000 (EUR 50,000 in the case of repetition).
Recommendation
- MAHs need to carefully plan the quantity of medicinal products they hold in stock in Austria accordingly.
- If MAHs are unable to maintain their stock of medicinal products for the period of four months, currently stipulated in the Annex, an authorised company must be sought to take over the stockholding obligation for the MAHs in accordance with a written agreement.
- MAHs need to ensure that they fulfil their reporting obligations to the BASG; this applies in particular to the demand report to be submitted, as well as reports on the use of certain exceptions.
- The costs incurred by the pharmaceutical industry as a result of the mandatory stockpiling of relevant human medicinal specialities in accordance with this new ordinance can be reimbursed by the BASG upon application under certain conditions. Kindly note that the application must be accompanied by proof of the additional costs incurred and confirmation from an independent auditor.
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