Accessible patient information leaflet

1a. How to submit accessible product information texts?

When submitting accessible product information documents in a procedure, please submit adequately formated accessible WORD documents using a document name ending with "_barrierefrei.docx", "_accessible.docx" or "_UA.docx". Thus, it is clear to the BASG that a closure of procedure with accessible documents is desired. Based on the final package leaflet an accessible PDF document has to be created and the file name has to be extended with the ending "_barrierefrei.pdf" or "_accessible.pdf" or "_UA.pdf".

Please confirm that the PDF/UA version is identical in content to the approved WORD version in the Comments when uploading to eService! In exceptional cases, this confirmation can also be sent by uploading the form "Approval including accessible national product information" with the Working Documents or informally by e-mail.

1b. How to submit accessible product information texts in case of type IA/IB variations?

In case of type IA/IB variations accessible PDF/UA documents can be submitted together with the respective WORD documents with submission or during the ongoing procedure. If the text in the WORD documents is amended, an updated version of the PDF/UA documents is required. Submission after finalisation of the text discussion is possible, too.

Please confirm that the PDF/UA version is identical in content to the approved WORD version in the Comments when uploading to eService! In exceptional cases, this confirmation can also be sent by uploading the form "Approval including accessible national product information" with the Working Documents or informally by e-mail.

2. How to submit accessible product information texts, if they can’t be submitted in the course of an ongoing regulatory procedure?

In principle, conversion to accessible product information texts should ideally be carried out within the framework of text-relevant variations or renewals (see also FAQs 1a and 1b). Only if no variations/renewals are currently ongoing or planned, the following way should be used! 

If texts (also for several products) are to be submitted without any ongoing regulatory procedures, a list of the reference numbers (“Grundzahlen”)/products concerned can be sent to cespbasg.gvat with the subject "Request for procedure initiation/accessible PLs" („Bitte um Verfahrensanlage/barrierefreie GIs“). Please separate the products according to AT RMS/ AT CMS/ National products and indicate where products with different strengths have common texts. Please do not apply for procedure initiation until the corresponding PDF/UA documents are available for upload in due time!

Please also note that the "Date of (last) revision" does NOT change due to conversion to accessible PLs, only. Further information can also be found in FAQ No. 14 on SmPC and PIL.

After the individual procedures have been created by the BASG, the accessible product information texts can be uploaded exclusively as PDF/UA in the eService to the respective medicinal products. The applicants see the procedures in the eService portal and should enter an e-mail address to be actively informed about the completion of the procedure. Otherwise, the respective procedures can be found in "Completed Applications" („Abgeschlossene Anbringen“) after completion by the BASG.

Please confirm in the Comments that the PDF/UA version is identical in content to the approved product information texts published in the Austrian medicinal product index when uploading to eService!

If you do not have eService access, you can apply for it at kundenregistrierung.basg.gv.at/kundenregistrierung or please contact cespbasg.gvat.

3. Does the BASG check the accessible package leaflet?

An additional check on the accessibility of the package leaflet will not be performed, this is the responsibility of the Marketing authorisation/Registration Holders.

4. Do I have to include a reference regarding the accessible package leaflet in the cover letter?

This is not necessary in case of MRP/DCP, where this should be indicated not earlier than in the context of the text discussion in the national phase.

In case of purely national procedures, inclusion of a respective reference in the cover letter is recommended.

5. Are there recommendations from BASG regarding the alternative text required for the symbols „Black Triangle“ and „Warning triangle”?

BASG recommends for the “Black Triangle” the alternative text “Symbol: Wichtig” (= “symbol: important”) and for the “Warning triangle” the alternative text “Symbol: Achtung” (= “symbol: attention”) as providing the meaning of the respective symbol is more relevant and useful for blind/visually impaired people than providing an actual description of the symbols. In the revised BASG Templates for human medicinal products (Version 2020), the respective alternative text for the Black Triangle is already added.

It is noted that the Marketing authorisation/Registration Holder is responsible for accessibility of package leaflet (this includes appropriate alternate texts).

6. Is left alignment of the text mandatory?

Left alignment of the text is in line with the conventional QRD requirements, most appropriate for accessible documents and for these reasons, recommended. Justifying text for instance, is consequently discouraged.

7. Is it allowed to deviate from the BASG Templates and adapt the line spacing?

In the revised BASG Templates for human medicinal products (Version 2020), the spacing between headings and text has been amended accordingly. In existing accessible documents, the spacing between headings 1 to 6 and the text can be changed to 12 pt without compromising the formatting. However, there is no obligation to adjust the line spacing.

Amended German QRD-Template documents providing for accessibility were prepared by the BASG and can be found here on the website of the BASG.

8. Is it allowed to deviate from the BASG Templates and use a different font?

You are free to choose an appropriate font; good readability has to be ensured.

Amended German QRD-Template documents providing for accessibility were prepared by the BASG and can be found here on the website of the BASG.

9. Will both package leaflets be published together?

Both package leaflets have to be identical in content! The Austrian medicinal product index has been reprogrammed. If an accessible package leaflet has already been provided, only this document is published. In case no accessible package leaflet has been provided, the conventional documents will continue to be published.

Consequently, both package leaflets will not be published together.

10. When checking accessibility in Word the link to the website www.basg.gv.at is always an issue. How can this issue be solved?

This accessibility error in Word can be ignored because after conversion to PDF/UA with a suitable tool this error does not occur when performing the accessibility check with PAC.

11. What has to be considered in order to achieve accessible tables?

It is advised to use a meaningful table heading to ensure that patients know whether a particular table is relevant to them.

In addition, clear column headings and/or heading lines should be chosen and adequately formatted (i.e. as a heading). In the accessible templates provided by BASG the respective formatting is “TabÜberschrift”. Further explanations can be found in the document Erstellung von U/A - konformen Dokumenten” (available only in German).

In the german-speaking area, tables are read from top left to bottom right. Consequently, no further information regarding the reading direction is necessary. The number of columns and lines is not important, but there should be an identical number of columns per line.

Omission of tables (or other content) in the accessible package leaflet, subsequent amendments or conversion into lists/numerations are not acceptable.

12. If a package leaflet has been created as an accessible Word document according to the respective template, isn’t it sufficient to simply save it as a PDF document?

Exporting Word documents (save as) does not create an accessible PDF/UA.

13. Are there sometimes problems reading aloud with Screenreader programs?

Sometimes terms like „5 x daily“, „1 2 tablets“ or abbreviations like „verw. bis.“ are read incorrectly.

14. May further heading levels be used or created for which there is no corresponding formatting in the BASG templates?

The number of heading levels actually required depends on the specific content of the document, e.g. the subheading "Children and adolescents" does not necessarily apply equally to every medicinal product or to all sections of the text. In addition, depending on the particular product/text content, additional sub-headings may be necessary for which there is no fixed specification in the QRD Templates or the respective guidance documents regarding wording, formatting and positioning in the heading hierarchy. To maintain this flexibility, a fixed formatting in the BASG templates is not considered appropriate. If necessary, however, further levels of headings can be created under your own responsibility, taking into account the hierarchy of headings.

15. Is the creation of links (bookmarks/cross-references) within the document for the accessible package leaflet accepted by the BASG?

Additional links within the accessible package leaflet as an additional function are accepted but not required by the BASG. These can be created for the accessible package leaflet on your own responsibility.

16. How to format the separator line above the “information intended for healthcare professionals” in the package leaflet so that it is not recognized as text or poses any accessibility issues?

If the separator line is necessary, instead of the specified separator line a continuous horizontal separator line can be created for the accessible package leaflet, e.g. in MS Word by entering the hyphen three times and then pressing the Enter key or by inserting a frame line.

17. Can the formatting "list paragraph" available in the BASG templates be used to create new lists?

The formatting "list paragraph" was adapted in the revised BASG templates for human medicinal products (Version 2020) according to the actual list formatting used. However, since the "list paragraph" formatting in MS Word does not differentiate between differently formatted lists within a document, it is not or only partially suitable for creating new lists. In addition, it should be considered that lists with multiple levels are not "preformatted" in the BASG templates, since the QRD templates only contain list elements of level 1. For this reason, it is recommended to format new lists using the paragraph settings in the "Start" tab.

18. What needs to be considered when creating alternative texts to images and are they approved by BASG?

The existence of alternative text for images is a basic requirement of the PDF/UA standard and is tested when a document is checked with PAC 3. However, neither the content of the alternative text nor the correct reading order within the document is checked by PAC 3. The choice of a suitable alternative text depends on several factors, including the information content of the image, the information content of the existing text, the positioning of the image in the continuous text, etc.

The responsibility for the choice of a suitable alternative text to the respective illustration lies with the marketing authorisation holder/registration holder. Minor deviations from the approved text are possible, provided they are necessary for accessibility. There is no official approval of alternative texts by the BASG.

19. May other minor text changes not related to accessibility be submitted concurrently (e.g. standard statements)?

No, but you can submit a corresponding variation and provide the package leaflet in an accessible format in the course of this variation.

20. Is inclusion of the front page as available in the BASG templates for the German package leaflet human mandatory for the accessible package leaflet?

No, the front page does not have to be included in the accessible package leaflet.

Contact

For specific questions regarding ongoing procedures please contact

for RMS applications rmsbasg.gvat

for CMS applications basg-cmsbasg.gvat

for purely national applications natbasg.gvat

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