Mandatory notification of supply shortages of prescription medicines

As of April 1st, 2020, marketing authorization holders must notify to the Austrian Federal Office for Safety in Health Care (BASG) if prescription medicines are not available or only available in limited quantities. Since the new regulation came into force, over 30 medicines have already been included in the BASG's register of distribution restrictions - most of them on the basis of a notification by the marketing authorization holder, but some also on the initiative of the BASG. These medicines are subject to a temporary export ban. Failure to comply with this ban may result in sanctions.

Who has to notify?

The marketing authorization holder is obliged to notify. If the marketing authorization holder fails to comply with his obligation to notify, the BASG may also ex officio include a medicinal product in the register of distribution restrictions.

When is a notification required in case of supply shortages?

Notifications must be made immediately if one of the following conditions is met:

• Non-availability of a prescription medicine in Austria for more than two weeks;

• Insufficient availability of a prescription medicine to meet the demands of patients in Austria for more than four weeks

• Elimination of these restrictions

What and how to notify?

The notification to the BASG has to be made via the electronic service "Admission and Lifecycle ASP" (“Zulassung und Lifecycle ASP”). The application form is to be filled in with detailed information, most of which is not published, but is used by the BASG to assess the notification. In particular, the following information must be provided:

• Name of the medicinal product and package size

• Reason for the restriction of distribution

• Current stock level of the distribution authorization holder

• Start of unavailability or limited availability and expected date of re-delivery

• Number of patients affected, market coverage, sales figures and calculated demand (per medicinal product)

• Essential medicinal product for the Austrian market: yes/no

• Extent of distribution restriction: national - EU/EEA - global

• Information on alternative products

• Customer information on the restriction of distribution

• Measures and investigation reports in case of quality deficiencies

• Contact telephone number

Review of the notification

The inclusion of the affected medicinal product in the register of distribution restrictions is not automatic, but only after the notification has been reviewed by the BASG. The following criteria are to be used in particular as a basis for the review:

• Number of patients affected

• Market coverage

• Average sales figures

• Demand and stock levels

• Available alternative medicines

Export ban and sanctions in case of supply shortages of prescription medicines

If the BASG concludes - either on the basis of a notification or ex officio - that a distribution restriction exists, the affected package size will be included in the register of distribution restrictions on the BASG website.

Medicinal products included in the register are - automatically - temporarily banned from export for the duration of their inclusion. At the request of the marketing authorization holder, the BASG must issue a decision on this export ban, against which an appeal may be filed. The export ban applies to all members of the distribution chain - marketing authorization holders, wholesalers and pharmacies. Violation of the export ban is subject to administrative penalties. In addition, claims for injunctive relief under civil law - based on unfair competition or trademark law – may be possible.

The information obligations and sanctions for medicines listed in the reimbursement code remain in place, i.e. if delivery difficulties persist or recur for more than two months, the drug may be removed from the reimbursement code.

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