News from Austria: Accessible patient information leaflet

News from Austria: Accessible patient information leaflet

Initial situation

In an arbitration process, the Federal Office for Safety in Health Care (BASG) was obliged according to § 14 of the Federal Disability Equality Act (BGStG) to request Holders of a Marketing authorization/Registration/Parallel import license to provide their Package Leaflets (PL) in an accessible format corresponding to the standard PDF-UA until 31.12.2020.

The arbitration process was triggered due to the fact that many of the Package Leaflets currently published in the Austrian medicinal product index according to § 27 of the Austrian Medicinal Products Act (Arzneimittelgesetz, AMG) are not available in an accessible format.

To support the potentially necessary revision of the Package Leaflets by Marketing authorization/Registration/Parallel import license Holders the Federal Office for Safety in Health Care (BASG) has prepared four amended German QRD-Template documents providing for accessibility:

These documents offered by BASG are intended to serve as support and can be used on a voluntary basis. Provision of the Package Leaflet in an accessible format is the responsibility of the Marketing Authorisation/Registration/Parallel import license Holder and is independent from use of the template documents offered by BASG.

It is recommended to also provide the Summary of Product characteristics (SmPC) in an accessible format in the context of changes to the product information.

This information and further details are originally published on the homepage of AGES under the following link.