FAQ Notification medicine shortages

Is there a possibility for distributors or an external service partner to assume the reporting obligation?

Local representatives of the marketing authorisation holders or distributors, which are either listed and clearly assigned in the package leaflet, or person(s) or companies authorised by the marketing authorisation holder, may apply for the role "notifier medicine shortage" in order to use the eService "Authorisation & Lifecycle MP". For this purpose, please contact medicineshortagebasg.gvat

Does the limited availability apply to each individual pack size? Does the notification have to be made if a different pack size is available?

A notification must be made as soon as a prescription-only medicine is limited available and the demand of patients is not met anymore. The notification and the data to be entered are always based on the marketing authorisation of the medicinal product and cover all pack sizes of the authorised medicinal product. In the course of the notification, the status of the availability ("not available", "limited available", "available", "not marketed") must be indicated for each pack size of the medicinal product. If not all pack sizes are marketed in Austria (e.g. there is no PIP code), the status for these shall be set to "not marketed".

How is "limited availability" to be defined?

A limited availability is considered to be a non-sufficient availability of a prescription-only medicine that does not meet demand and lasts at least four weeks. The adequate and continuous supply of the proprietary medicinal product for distribution by pharmacies or other licence holders for distribution in accordance with § 59 Austrian Medicines Act is not ensured during this period.

 

What is the meaning of the status "not available", "limited available", "available", "not marketed"

For each marketing authorisation of a medicinal product various pack sizes are approved. Not all of them are actually marketed in Austria.

"not available" means: The pack size of the medicinal product can no longer be dispensed by pharmacies in Austria.

"limited availability" means: The pack size of the medicinal product can no longer be supplied continuously and in sufficient quantities by pharmacies in Austria.

"available" means: The pack size of the proprietary medicinal product can be dispensed continuously and sufficiently by pharmacies in Austria.

"not marketed" means: The pack size of the medicinal speciality is approved, but has never been marketed in Austria.

How do you deal with medicinal products that are authorised but not marketed?

Not marketed pack sizes of a medicinal product must be notified as "not marketed".

However, if a medicinal product with all its approved pack sizes has never been marketed in Austria or the marketing cessation is permanent, a shortage-notification is not necessary, but you have to announce the marketing status in the eSercive "Marketing authorisation & lifecycle MP".

Are veterinary medicinal products covered by the notification regulation?

No, the regulation on ensuring the supply of medicinal products is restricted to prescription-only human medicines.

Do centrally authorised medicinal products also have to be reported?

Yes, centrally authorised medicinal products that are prescription-only medicines must be reported.

How long does the BASG have time to publish a not available or limited available medicinal product?

The processing within the BASG business hours shall always be carried out immediately. The processing time may be extended due to a high volume of notifications and the individual review of each notification. The notifications are always published in the public catalogues after successful processing by the BASG on the day after.

How does the BASG check whether a parallel export ban is applicable?

The review is carried out using the decision tree (see chart), which takes into account the mandatory fields "size of population affected by the shortage ", "market share", "market sales volume", "calculated patient need", "stock available at MAH" and "available potential alternative medicinal products".

Does the new reporting system also require old notifications already submitted before April 1, 2020 to be submitted again?

The old notifications are transferred to the new system. If it is necessary for the BASG to contact the marketing authorisation holder or the notifier, or vice versa, in order to examine a possible parallel export ban, the new mandatory fields "size of population affected by the shortage ", "market share", "market sales volume", "calculated patient need", "stock available at MAH" and "available potential alternative medicinal products" must be submitted subsequently.

How do you deal with medicinal products that have not been available for months, do they have to be reported?

Yes, any restriction in supply of a prescription-only medicine must be reported immediately.

What should be done if a marketing authorisation holder is able to supply sufficient quantities, but pharmacies and patients still report that the medicinal product is not available?

In this case § 4 para. 1 of the regulation on ensuring the supply of medicinal products applies. Please contact medicineshortagebasg.gvat with a description of the facts of the case and do not make any prior notification via the eService portal or only in consultation with the BASG.

What is to be done if a marketing authorisation holder is no longer able to supply because the market leader has failed to supply?

In this case § 4 para. 1 of the regulation on ensuring the supply of medicinal products applies. Please contact medicineshortagebasg.gvat with a description of the facts of the case and do not make any prior notification via the eService portal or only in consultation with the BASG.

 

What is to be done if a marketing authorisation holder has to set a quota for the goods in stock in order to ensure supply and avoid stockpiling or parallel exports?

In this case § 4 para. 1 of the regulation on ensuring the supply of medicinal products applies. Please contact medicineshortagebasg.gvat with a description of the facts of the case and do not make any prior notification via the eService portal or only in consultation with the BASG.

What is the procedure to be followed in the case of a parallel export ban if there are common packaging materials for the medicinal product for several countries (multi-country presentations)?

Packages with a "multi-country presentation" may not be exported in parallel from Austria, as the authorisation holder intended them for Austria and placed them on the Austrian market.

What are the consequences of failing to report a medicine shortage?

If the BASG becomes aware that the marketing authorisation holder is not or not fully complying with its obligations under the regulation on ensuring the supply of medicinal products, the BASG must initiate an appropriate review by the authorities (see § 3 of the regulation on ensuring the supply of medicinal products). Pursuant to § 84 para. 1 no. 23 of the Austrian Medicines Act, a violation of the regulation on ensuring the supply of medicinal products 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.

Is the fee to be paid per notification, per medicinal product or per PIP code? New

The fee has to be paid per notification of the proprietary medicinal product and not per pack size. The amount of the fee can be found in the current regulation of fees. The fee must be paid since July 1, 2020.

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