Creating Accessible Package Leaflets

messages in brief | 01/07/2020

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.

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 as well as a user-guide.

Besides these technical measures additional steps may have to be taken with regards to the content of the document to ensure accessibility. This should already be taken into consideration when documents are set up:

  • 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 generally be avoided, as readability by screen reader programs might not be ensured.
  • Furthermore, 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. Hereby, it can be ensured that in the course of reformatting after final approval of texts accessible documents can be produced.

Further information can be found in the document „Erstellung von U/A - konformen Dokumenten“ (available only in German) and in the guidance documents, information and FAQs related to accessibility of documents provided below (see link to BASG below).  

Please note that all package leaflets have to be published in an accessible format on Arzneispezialitätenregister at latest at 31.12.2020.

If you want to submit accessible texts already, please inform BASG for national procedures at the beginning of the procedure and for MRP/DCP procedures at the beginning of the national implementation phase by submitting WORD-files with corresponding names, e.g. “_barrierefrei.docx“, “_accessible.docx“ or “_UA.docx“. Final texts will be provided to you as Word document. Based on them accessible PDF has to be generated by the applicant, document name should end with “_barrierefrei“, “_accessible“ or “_UA” and should be submitted before end of this procedure. Within type IA and type IB variations PDF UAs can be submitted with application. For further details, please refer to FAQs.

If accessible package leaflets need to be submitted without any text-relevant variations, exceptionally, a national art. 61(3) notification should be submitted.

It is also possible to provide a list of products, in which accessible package leaflets should be provided, to cespbasg.gvat (please sort according to AT=RMS/AT=CMS/national and indicate products sharing combined texts). BASG starts respective procedures and marketing authorisation holders can upload via eService.

As of June 2020, only about 20% of all package leaflets were declared accessible, and only about 2/3 met the requirements for accessibility in accordance with PAC3.

Therefore, Marketing Authorisation Holders are strongly reminded to start with the corresponding conversions and to use suitable conversion programs for the creation of PDF UAs.

And please keep in mind „einmal barrierefrei = immer barriefrei“

References

Please find further information respectively FAQs at

https://www.basg.gv.at/en/companies/marketing-authorisation-life-cycle/marketing-authorisation-procedure/accessible-patient-information-leaflet

https://www.basg.gv.at/en/companies/marketing-authorisation-life-cycle/faq-marketing-authorisation-life-cycle/accessible-patient-information-leaflet

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