1. What is Braille?
Including the product name in Braille in the labelling of human medicinal proprietary products and preparing patient leaflets in a format appropriate for blind and partially sighted individuals.
Braille is an internationally used system enabling blind and partially sighted individuals to read and write. The system was developed in 1825 by the French Louis Braille, who himself was blind. The basic Braille symbol is referred to as the Braille cell, which consists of 6 dots. Each letter, number, or punctuation mark is represented by a specific pattern of dots.
Braille is a writing system read by using the fingers’ tactile sense. Therefore, to enable reading, certain standards have to be adhered to. The recommended standard is ‘Marburg Medium’ with its specific dot spacing, dot height, and point shape.
For transcription, literary Braille should be used to make the text legible for everyone reading Braille. Basic or computer Braille (character-to-character transcription) should not be used. Likewise, Braille shorthand should not be used because not everyone reading Braille is familiar with it.
2. According to the provisions of Art 17 para 5 AMG, the name and the strength on the outer packaging of a proprietary medicinal product must also be expressed in Braille format. What is the effective date of these provisions and to which products do they
The provisions of Art 17 para 5 AMG apply to all human proprietary medicinal products approved after entry into force of the amendment to the Austrian Medicinal Products Act (Arzneimittelgesetz, AMG) on 2006-01-02. Proprietary medicinal products approved before the entry into force of the amendment should be made compliant with these requirements as soon as possible, but by 2011-01-01 at the latest.
Medicinal products in accordance with Art 7a AMG (desensitisers) and registered homoeopathic medicinal products are not covered by these provisions.
For proprietary medicinal products administered exclusively by healthcare professionals (e.g., vaccines, solutions for infusion, etc.), adding the product name in Braille is not required.
For small-volume packaging (e.g., up to 10 mL) that do not provide sufficient space, abbreviations or specials arrangements can be applied for.
In the case of multilingual packaging with different product names, each of the product names must be added in Braille.
3. Where on the packaging should the product name in Braille format be positioned?
The trade name (invented name, generic name) and the strength must be included in the labelling of the outer packaging of a proprietary medicinal product. In justified exceptional cases, when only one strength of a given proprietary medicinal product is approved, it is sufficient to emboss only the trade name in Braille format. The essential goal is to allow a blind or partially sighted reader to unequivocally identify the medicinal product in question. Marketing authorisation holders are free to emboss additional information (e.g., pharmaceutical form, shelf life, etc.) on large packaging.
The name in Braille format has to be included only on the outer packaging, which in most cases will be a folding carton. The primary packaging has to be embossed only for products without outer packaging.
To guarantee the legibility of any information added in Braille, embossing must not damage the surface material of the packaging. Also, the legibility of any underlying text must not be compromised. If necessary, a line break on one side of the folding carton is admissible. Adding self-adhesive labels with the product name in Braille at pharmacies or drug stores is clearly discouraged.
4. Which documents and data related to the Braille provisions must be submitted to the Federal Office for Safety in Health Care (BASG)?
At the time of submission of the application dossier, the applicant has to specify, in Section 1.3.6 of Module 1 and in normal script, how the provisions of Art 17 para 5 AMG will be implemented (trade name and strength). If possible, dots on the mock-up should clearly indicate where on the packaging the name and the strength will appear.
At the time of application, the submitted specimen does not have to include the embossed Braille. After the product has been brought to market, the MAH has to submit, at the request of the BASG, a specimen of the outer packaging. The responsibility for checking the legibility of the texts presented in Braille rests with the MAH.
Applicants who wish to invoke a derogation have to specify this in Section 1.3.6, together with an appropriate justification.
For already approved medicinal products, the MAH is merely required to notify the authorities of the inclusion of the Braille in the labelling, preferably together with other changes. This specific notification is free of charge. The notification does not have to be submitted before inclusion of the Braille on the packaging. A specimen of the outer packaging does not have to be submitted until requested by the authorities.
5. What format should be used to make the information in the package leaflet available to blind and partially sighted individuals?
There are several options for making the information in the package leaflet available to blind and partially sighted individuals at their request. Thus, the package leaflet can be printed using larger font sizes (16–20 point, good contrast, etc.).
Alternatively, the package leaflet can be made available as an audio file or mailed as a digital text document, or the information can be communicated via hotline. It is the responsibility of the marketing authorisation holder to make the current version of the patient leaflet available in a format appropriate for blind and partially sighted individuals.
Created: 15.04.2009 | Page last modified: 06.05.2015