Accessible patient information leaflet

1. When do I have to submit an accessible package leaflet?

Please note that by 31.12.2020 at the latest, all package leaflets published in the Austrian medicinal product index must be available in an accessible format. This should primarily be done during the next upcoming variation or in the context of a renewal. If no regulatory procedure occurs within this timeframe, an Art. 61(3) notification (or C.II.6.b for veterinary products) has to be submitted via CESP. An application can be submitted either as an eCTD sequence or outside the eCTD lifecycle, by submitting the form via CESP. In exceptional cases, the form may also be sent by e-mail to cespbasg.gvat. Once the procedure has been initiated, the accessible documents must be uploaded to the eService. Please confirm in the eService with a comment that the PDF UA version is identical in content to the barrier-free WORD version published in the ASp register! Please confirm in the Comments when uploading to eService that the PDF UA version is identical in content to the currently approved version published in the Austrian medicinal product index! 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.

2a. 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.

2b. 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.

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.

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?

The Spacing between headings 1-6 and the text can be changed to 12 pt without compromising the formatting.

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 and subsequent amendments are not acceptable.

12. If a PL 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.

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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