Creating Accessible Documents

messages in brief | 29/09/2020

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 authorisation/Registration/Parallel import license to provide their Package Leaflets (PL) in an accessible format corresponding to the standard PDF/UA until 31.12.2020.

Please note that all package leaflets have to be published in an accessible format on Arzneispezialitätenregister at latest at 31.12.2020. Detailed guidance how to submit PLs in accessible format can be found under FAQ 1a, 1b and 2 as linked below.

So far, only a part of all package leaflets were declared accessible, and only about half met the requirements for accessibility in accordance with PAC3.

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

And please keep in mind „once accessible = forever accessible“

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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