Nov 15, 2019
Austria plans marketing authorization holders registration and drugs export ban
In order to be able to respond promptly to delivery bottlenecks in prescription medicines, Austria is planning a central registration requirement for marketing authorization holders. In addition, there should be an export ban for respective drugs.

The growing global problem of supply bottlenecks in prescription drugs makes it more and more difficult for physicians and pharmacists to supply patients adequately with the desired medicines or to provide a replacement at short notice. The Austrian government now wants to take countermeasures and obligate pharmaceutical companies by regulation to become more transparent about impending bottlenecks and shortages.

In order to enable physicians and pharmacists in Austria to react in good time to restrictions on the marketing of prescription drugs in the future, the draft regulation provides the introduction of a registration obligation for the marketing authorization holder. All respective medicines should be publicly available in a register on the homepage of the Federal Office for Safety in Health Care (BASG).

According to the regulation, a prescription drug is considered to have limited marketability if it is not expected to be available at all for more than two weeks or if it is not sufficiently available for four weeks to meet the needs of the population. Once the ability to deliver is guaranteed again, the pharmaceutical company must inform the Federal Office, and the register will be updated accordingly.

At the same time, an export ban is also planned for non-deliverable or supply-restricted drugs: for reasons of public health protection, the export of prescription medicines published in the list of the Federal Office for Safety in Health Care to another contracting party of the European Economic Area will be prohibited.

The draft regulation of the Austrian Ministry of Health on ensuring the supply of medicines is now available to the EU Commission for notification. At the end of the three-month standstill period, during which the Member States can comment on the project, the regulation could enter into force at the end of January 2020.

The full details in German can be found here. The regulation draft in German is available here.

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