Accessible patient information leaflet
Accessibility is essential for 10 percent of the population, necessary for 40 percent of the population and comfortable for 100 percent of the population. Everybody benefits from an accessible environment.
(Source: Barrierefreie IKT - zum Nutzen aller, Broschüre, Dezember 2016, Digitales Österreich; available only in German)
Accessibility allows people – with and without disabilities – unrestricted use of services, facilities and items of everyday life. According to the Austrian Federal Disability Equality Act (Bundesbehindertengleichstellungsgesetz, BGStG) this is achieved if use is possible in a generally customary way, without any particular difficulty and, in principle, without outside help.
Products should generally be suitable for all users without additional adaptations. This is the idea of "Design For All".
Accessible communication allows all people full access to digital media, television content, websites and online services
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:
- Gebrauchsinformation human (German Package leaflet human)
- Gebrauchsinformation veterinaer (German Package leaflet veterinary)
- QRD-Template human (German QRD-Template human)
- QRD-Template veterinaer (German QRD-Template veterinary)
- QRD combined label-leaflet template veterinaer (German Template)
These documents can be found in the Downloads section.
The BASG Templates for Human Medicinal products were adapted to the current version of the EMA QRD Templates in July 2020 and slightly revised. Furthermore, in May 2022, the BASG templates for veterinary medicinal products were revised in accordance with the new QRD version 9 (implementation of text related requirements due to Veterinary Medicinal Product Regulation (EU) 2019/6) and the new QRD combined label-leaflet template was added.
Further information can be found in the FAQs. To ensure that changes can be tracked, the previous versions of the BASG templates are still available in the Downloads section.
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.
The amended templates offered by BASG differ from the EMA QRD-Templates with respect to the newly prepared electronic format. Therefore, they provide a respective heading structure and organization of content to enable screen reader users to efficiently navigate through the documents.
This electronic structure can be made visible by using the navigation pane (in Tab “View” - “Show” button group - “Navigation Pane” checkbox) in MS Word. The „visual format“ (font size, font, style – bold, underlined, etc.) remains identical to the specifications of the EMA QRD-Templates.
For creating an accessible Word-document the templates offered by BASG can be used by inserting text into the template while keeping format and structure unchanged.
Alternatively, an existing Word-document can be adapted with regards to accessibility by using the built-in Heading styles providing for an adequate heading structure and format.
Besides these technical measures additional steps may have to be taken with regards to the content of the document to ensure accessibility. Alternate text has to be added for pictures and symbols and a suitable format for lists and tables has to be considered. Complex tables should be avoided. Holders of a Marketing authorization/Registration/Parallel import license are recommended to run the Accessibility Checker before submission of the final texts in MS Word to verify accessibility of the respective document. Further information can be found in the document „Erstellung von U/A - konformen Dokumenten“ (available only in German) and in the guidance documents and information related to accessibility of documents provided below.
Once content-related text discussion with BASG is finalized with regards to the Word documents, Marketing Authorisation Holders/applicants are required to provide and submit an accessible PDF document. [It is recommended to use the product name for the document titel]
- Accessible Template: German Package leaflet for medicinal products for human use, version 202027/07/2020
- Accessible QRD template (MRP/DCP) for medicinal products for human use, version 202027/07/2020
- Accessible Template: German Package leaflet for medicinal products for veterinary use, Version 9.0 (202210/2021)24/05/2022
- Accessible Template: German combined label-leaflet template, Version 9.0 (04/2022)24/05/2022
- Accessible QRD template for medicinal products for veterinary use, Version 9.0 (202210/2021)24/05/2022
- Accessible Template: German Package leaflet for medicinal products for veterinary use, version 201831/08/2018
- Accessible German QRD template for medicinal products for veterinary use, version 201831/08/2018
- Accessible Template: German Package leaflet for medicinal products for human use, version 201831/08/2018
- Accessible QRD template (MRP/DCP) for medicinal products for human use, version 201831/08/2018
DIRECTIVE (EU) 2016/2102 on the accessibility of the websites and mobile applications of public sector bodies
RICHTLINIE (EU) 2016/2102 über den barrierefreien Zugang zu den Websites und mobilen Anwendungen öffentlicher Stellen