This information is intended for use by pharmaceutical organisations and packaging suppliers.
How can we help?
We offer many different services which will help you to both comply with your legislative obligations under EU Council Directive 2004/27/EC - Article 56(a), and meet the needs of your blind and partially sighted customers.
We have tried to answer the most frequently asked questions below, but if you can't find the answer you need then call us on 01733 37 53 70 or email businesslink@rnib.org.uk and we'll do our best to help.
We can help with braille on the pack
Subscription to pharmaceutical braille packaging website
Offering subscription based access to the soon to be launched EBU Braille for Pharmaceutical Packaging website, where you will find advice on producing braille for packaging that is distributed into different EU countries.
Here you will be able to access information including:
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Details of the code that has been agreed between many European blind organisations
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Details of those countries who have agreed to the use of this code and those who have not
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Each country's national code is also displayed where the information has been made available.
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Advice on how the braille code should be implemented, for example: spacing, abbreviations, capitalisation and location on the pack
For more information please visit our EBU pharmaceutical information page
Black dot artwork
This is the artwork that labels or tooling may be generated from. It shows the pattern of the braille dots.
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Producing black dot artwork - we can provide you with the artwork
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Checking your black dot artwork - send us your artwork and we'll check what it says
Pharmaceutical braille training
We will come to you to train your staff on how to proofread braille for pharmaceutical packaging. A very interactive and participative course with an RNIB braille expert.
We can help with Patient Information Leaflets
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Providing an automated, cost effective solution for providing accessible formats of your Patient Information Leaflets (vist our X-PIL page for more details)
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Advising on different ways of producing accessible information through more manual processes if required, and directly producing the information in a variety of formats
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Offering design advice and training to help you produce clearer print on packaging, to overcome readability issues faced by many people. Over 25 million people in the UK have presbyopia which makes reading small print very difficult.
Frequently asked questions
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 does 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 runs for 5 years. All marketing authorisations must therefore comply by 30 October 2010. Again for more detail please refer to Medicines and Healthcare products Regulatory Agency Information Centre (MHRA)
3. What text do I include on my 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:
Article 56(a)
"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:
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braille
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large print
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audio formats (audio cassette, audio-CD and DAISY)
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CD Roms and text files by email
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delivery over the phone (audio recordings of leaflets with an ordering facility)
We can help you to provide accessible formats of your Patient Information Leaflets. Please see or call 01733 37 5370 or email businesslink@rnib.org.uk for advice on XPIL and other accessible information services.
5. Are there any standards or guidance to refer to?
We would recommend that guidance is taken from the following sources
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MHRA
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British Standards Institute - The current British Standards Institute (BSI) Draft for Development refers to a dot height of 0.12 mm for embossed materials and 0.2 mm for other materials. It also provides advice on aspects such as dot height, spacing, measuring techniques and positioning, and can be purchased directly from the British Standards Institute.
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European Standard Developments - CEN - these are currently under review and are expected to be published in early 2010. Please contact your local standards body for current updates.
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RNIB - please also see information on the XPIL webpage and EBU Braille for Pharmaceutical Packaging (subscription based) webpage
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European Blind Union
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Local braille authorities for the countries you distribute in.
RNIB and the EBU in the spirit of compromise accept the current recommendations made by BSI although we would strongly recommend that a minimum target height of 0.2mm is aimed for as a much higher percentage of braille readers can identify braille at this height, and this is likely to be the target height set in the future. This view is supported by the braille dot height research that been carried out as part of the CEN (The European Committee for Standardization) standard development process.
Through the CEN process RNIB, EBU and key stakeholders in the pharmaceutical industry and related packaging industry have carried out very thorough and lengthy consultations and negotiations as part of the standard development process. This will result in the publication of a document defining target dot height and tolerances. We believe that CEN will strive to set a target height of 0.2mm, and that minimum parameters will be set to ensure that dot height does not fall below 0.12mm. This document is due to be published in 2010 and we recommend contacting BSI for an update on progress.
6. What about producing braille on packs across Europe?
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.
Please see question 7 next on this page for more detail.
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 are working with the European Blind Union (EBU) and other braille authorities across Europe to find a way to help ease some of the difficulties. We 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. Please read our information on EBU Braille for Pharmaceutical Packaging
RNIB are happy to provide you with 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.
Please also see question 6 on this page.
8. Can RNIB help with PILs (Patient Information Leaflets)?
RNIB have an efficient and cost effective solution to help you provide your patient information leaflets to your blind and partially sighted customers in the formats they require. The solution is called X-PIL and more information can be found on our X-PIL page.
9. Can I make the braille bigger or smaller to fit the pack?
No. There are guidelines for dimension and height please see
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).
10. What is the difference between contracted and uncontracted braille?
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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.
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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).
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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. Please see Medicines and Healthcare products Regulatory Agency Information Centre (MHRA)
Please also see our page on EBU Braille for Pharmaceutical Packaging
11. Where should the braille go on the pack?
RNIB leaves the final decision to the pharmaceutical organisations under the guidance of MHRA. However, you should ensure that the print underlying the braille text remains legible. This will require careful decisions about where to put the braille. RNIB is happy to assess sample packaging for print distortion as well as braille legibility. Please note that the new BSI Draft for Development and CEN standard refer to this.
12. What can you tell me about production methods?
We would advise you consult with carton manufacturers and label manufactures' with experience in braille production and knowledge of the current guidance. Current methods include screenprinting and embossing both on the carton or on labeling material. You can send us your packs for an assessment of the braille you've produced or we can train you on proofreading it. Call us on 01733 37 53 70 or email us at businesslink@rnib.org.uk
13. Where can I buy Marburg Medium?
Marburg Medium is a specification rather than a font. Many companies are choosing to use a standard font for artwork and then asking their manufacturers to meet the Marburg Medium specification. If you have further questions about how close your braille font is to Marburg Medium then we recommend that you contact your braille software supplier.
14. Does RNIB cover other countries?
Although RNIB has contacts across the world, we are a UK charity. We do have equivalent organisations across the world, please search on our International Database of Organizations for details
15. What does the MHRA say?
Apart from the EBU and X-PIL content on the RNIB website, we recommend that you read through the information provided by the Medicines and Healthcare products Regulatory Agency Information Centre (MHRA), particularly their October 2005 "Question and Answer" document.
They have a great deal of advice on their web site and can be contacted directly for more information.
16. Was RNIB involved in campaigning for this Directive?
RNIB's Public Policy Team was instrumental in campaigning for the inclusion of braille labeling in EU Council Directive 2004/27/EC - Article 56(a). RNIB have a strong pedigree in campaigning activity and have been fundamental in bringing about or amending legislation, regulations, standards and guidelines in a way has a huge impact on improving the lives of people with sight loss and helping to prevent sight loss.
Find out about our current Access to Information campaigns including "Losing patience - accessible health information".
17. How can I support RNIB?
You can support RNIB as an individual or an organisation. Have a look through our Get Involved section for inspiration and get in touch.
Contact us
RNIB help for pharmaceutical companies
RNIB Disability Access Services
Tel: 01733 37 53 70
Email: businesslink@rnib.org.uk
RNIB campaign activity:
RNIB Public Policy Team
Tel: 020 7391 2123
Email: campaign@rnib.org.uk
Regulations for the UK market
MHRA Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000
Email: info@mhra.gsi.gov.uk