1. What does the EU Directive say?
The EU Directive says:
Council Directive 2004/27/EC – Article 56(a)
“The name of the product, as referred to in Article 54, point (a) must also be expressed in braille format on the packaging. The MA holder shall ensure that the packaging information leaflet is made available on request from patients’ organisations in formats appropriate for the blind and partially sighted”
The pharmaceutical directive applies to all medicinal products for human use intended to be place on the markets in the Member States. All EU legislation relating to pharmaceutical products is covered under the EEA Agreement and so the EEA areas (Iceland, Liechtenstein and Norway) will also be implementing this directive.
2. When did the legislation come in?
UK requirements have affected all products that were granted marketing authorisation from 30 October 2005 onwards. For medicines that had marketing authorisation prior to this date, the transitional period in the UK ran for 5 years. All marketing authorisations must therefore have complied by 30 October 2010. For more detail please refer to Medicines and Healthcare products Regulatory Agency Information Centre (MHRA).
3. What information must appear in Braille on the pack?
The product name must be put in braille. If there is more than one formulation and or more than one strength this will also need to be expressed in braille. For more specific information please refer to either
4. What about Patient Information Leaflets?
The EU Directive says:
“The MAH shall ensure that the package information leaflet is made available on request from patients’ organisations in formats appropriate for the blind and partially sighted”
The different formats that may be requested include:
- large print
- audio formats (audio cassette, audio-CD and DAISY)
- CD Roms and text files by email
- delivery over the phone (audio recordings of leaflets with an ordering facility)
In the UK the RNIB can help you to provide accessible formats of your Patient Information Leaflets. Call 01733 37 5370 or email firstname.lastname@example.org for advice on XPIL and other accessible information services.
5. Are there any standards or guidance to refer to?
It is recommended that guidance is taken from the following sources:
6. What about producing braille on packs for more than one country?
Each European country has its own braille code. There are some commonalities but there are some important differences. We appreciate that this can cause difficulties in producing braille on packs that are distributed to more than one market. Although the Latin names maybe the same across many markets this doesn’t guarantee that the same braille can be used. However, there are occasions when the braille translation can be used in more than one country.
7. Is Braille a universal language?
There will be differences between the countries (as there would be for written languages such as French, German and English) but because some pharmaceutical names are similar across the EU, discussions are taking place to see if a unified system of braille can be adopted for this purpose.
RNIB and the European Blind Union (EBU) are working together with other braille authorities across Europe to find a way to help ease some of the difficulties. They are trying to set a common braille code to be used on pharmaceutical packaging but not all European countries have accepted this proposed code and require the local braille code to be used. For example France will only accept their own braille code.
The EBU guidance is designed to cover alphabets, numbers and symbols.
RNIB can provide braille artwork, proof-reading and PILs transcription for packs to be used in the UK. However, if your pack or PIL is intended for use elsewhere in the EU then we recommend that you consult our equivalent organisation in the country where the braille will be used.
8. The pack is too small for Braille. Can I reduce the size of Braille?
The Braille must not be reduced in size to fit the pack. The Braille must follow the dimensions specified in the Marburg Medium Standard.
In the case of small volume packages with limited space, alternative means of providing Braille information may be considered, e.g. the addition of supplementary “tab” on the carton.
If you are short of space on a pack, remember braille can be hyphenated. If necessary you can also have braille on more than one side of your pack. Braille should be uncontracted although you are allowed to use contracted braille for small volumes (up to 10ml).
9. What is the difference between contracted and uncontracted braille?
- Grade 1 or uncontracted braille is used simply to produce a letter-by-letter copy of print. It is seldom used for long documents, as it takes up a lot of space and is comparatively slow to read. However, it is used for signage and labelling because it makes braille more accessible for less fluent braille readers and can even be read by someone who has a braille alphabet card to refer to.
- Grade 2 or contracted braille was developed to reduce the size of books and make reading quicker – because there are fewer braille symbols. This is why contracted braille has been allowed on pharmaceutical packaging for small volumes (up to 10ml).
- Braille Code sheets have been developed showing A-Z, numbers, some symbols and some abbreviations for the UK and the proposed code for across Europe.
10. Where on the labelling should the Braille text be located?
It is preferable for the Braille text to appear on the front of the pack but this is not required. Braille text, if placed over other statutory information must not impair readability of the statutory information for sighted patients. Use of a suitable “white space” on the packaging where available, is considered preferable for the application of Braille text. The exact position will require careful decisions about where to put the braille. In the UK RNIB is happy to assess sample packaging for print distortion as well as braille legibility. Please note that the new BSI and CEN standards publications refer to positioning of Braille.
11. Can I use contracted Braille?
Generally no. Contracted Braille is a form of abbreviation and the information which has to be placed on a medicines label is not easily abbreviated. The full text should be used when applying Braille to medicines labels and packs. However, contracted Braille is allowed for small volumes (up to 10ml).
12. Does Braille have to be applied to blister strips?
The application of Braille should be to the secondary packaging i.e. the carton. Blister strips therefore do not require Braille labelling. If there is no outer packaging, such as a carton, the Braille must be on the primary label.
13. Does Braille need to be applied to containers which are not subsequently enclosed in an outer carton—for example bottles?
Yes, if a bottle is presented with only a paper label applied to the container surface and no outer carton Braille is still required on the label.
14. Is Braille required on herbal medicines?
Yes. For Herbal Medicinal Products the Braille requirement will be restricted to the (invented) name of the medicine only. Where the name consists of the active substance(s), information could be limited to the plant name (including the plant part in those cases where several parts are available), plus the type of preparation and the strength, if several strengths exist.
15. Which Braille format should I use for my packaging?
The guidance for American Markets and the standards published by the European Commission recommend the use of Marburg Medium.
16. Which medicines must have Braille on the packs?
All medicines which will be handled directly by patients require Braille.