Training and Consultancy

EU Directive relating to pharmaceutical labelling

Summary: Information for use by pharmaceutical organisations and their packaging suppliers

• What does the EU Directive say?
• What about Patient Information Leaflets?
• Are there any standards or guidance that can be referred to?
• Was RNIB involved in campaigning for this Directive?
• How are RNIB helping companies now?
• How can RNIB help with PILs (Patient Information Leaflets)?
• Answering your questions
• Contact information
• Other ways we can help

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This information is intended for use by pharmaceutical organisations and packaging suppliers. It has been produced by the Business Development Team.

Pharmaceutical organisations and packaging suppliers are also recommended to read through the information provided by the Medicines and Healthcare products Regulatory Agency Information Centre (MHRA), particularly their October 2005 "Question and Answer" document.

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"

If you are unsure about which text to include on your pack, please refer to the guidance contained in the MHRA "Question and Answer" document.

This came into force on 30 October 2005. To summarise:

• UK requirements will affect all products granted marketing authorisation from 30 October 2005.
• For medicines that already have marketing authorisation, the transistional period in the UK runs for 5 years. All marketing authorisations must therefore comply by 30 October 2010.

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:

• braille
• large print
• audio formats (audio cassette, CD-Audio and DAISY
• CD Roms and text files by email
• delivery over the phone (audio recordings of leaflets with an ordering facility

RNIB can help you to provide accessible formats of your Patient Information leaflets.

Are there any standards or guidance that can be referred to?

DD 264:2007 Packaging. Braille and other formats for medicinal products

This Draft for Development (DD) details the requirements and provides guidance for the application of Braille to the labelling of medicinal products. It also discusses issues relating to how patient information leaflets should be supplied in formats suitable for Blind and partially sighted people.

Details of how this document can be purchased can be found on the BSI website.

RNIB have been involved in the consultation process for this Draft for Development and support the recommendation and guidance given. However, please note that in relation to Braille Dot Height research is ongoing to establish an acceptable Braille Dot Height. RNIB considers the dot height referred to in the BSI standard a temporary position subject to change following the completion of the research and negotiation with European stakeholders including Blind organisations, pharmaceutical organisations, carton manufacturers, label producers and relevant association bodies. Please see further information about progress.

Progress with CEN Standards

A further CEN meeting was held on the 3rd and 4th March 2008. The final draft for submission is being circulated.

The Braille Dot height research commissioned by RNIB and conducted by the University of Birmingham was reviewed by the CEN Working Group. The agreed braille dot height was added to the final draft.

Please contact the RNIB Business Development Team for any further details.

European Blind Union Guidance - Alphabets, numbers and symbols

The European Blind Union (EBU) have circulated a Guidance Document for use by the pharmaceutical industry and supporting organisations which includes the use of alphabets, numbers and symbols. Please read further information on this EBU Guidance.

Was RNIB involved in campaigning for this Directive?

RNIB's Public Policy Team was instrumental in in campaigning for the inclusion of braille labelling in this EU Directive. You can find out more at the Campaigns page for this Directive.

How are RNIB helping companies now?

RNIB are helping pharmaceutical organisations and packaging suppliers in various ways

RNIB services for the pharmaceutical sector include:

• a training course: proofreading braille on pharmaceutical packs
• producing black dot artwork for braille
• proofreading black dot artwork for braille
• assessing the physical braille on sample packs
• providing a range of braille training
• giving advice on provision of PILs in alternative formats
• producing PILs in alternative formats
• working with the trade bodies to communicate solutions to wider audiences

For information about these services, please contact our RNIB Business Development Team.

How can RNIB help with PILs (Patient Information Leaflets)?

RNIB are able to provide an efficient and cost effective solution that provides your blind and partially sighted people with rapid access to the essential patient information leaflet.

Please contact our RNIB Business Development Team for further details of this solution.

Answering your questions

1. Can I make the braille bigger or smaller to fit the pack?

No. The Commission Guidance relating to the EU Directive for pharmaceutical labelling is for Marburg Medium Braille. The specification for Marburg Medium can be found on our RNIB Scientific Research Unit website

Marburg Medium specification does not contain a measurement for the height. RNIB recommends a minimum height of 0.46mm in standard production processes. The European Blind Union (EBU) suggests a minimum height of 0.5mm +/- 0.05mm.

However, in the instance of Braille on Pharmaceutical packaging RNIB have accepted the reference to a lower Braille dot height DD 264:2007.

If you are short of space on a pack, remember braille can be hyphenated. If it is absolutely necessary then 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).

Please also refer to information about standards and guidance.

2. What is the difference between uncontracted and contracted 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.

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).

We have also developed an A-Z braille sheet with those symbols likely to be used on pharmaceutical packs. If you would like a copy sent to you, please contact our RNIB Business Development Team.

3. Where should the braille go on the pack?

RNIB leaves the final decision to the pharmaceutical organisations. However, they 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 Draft for Development and CEN standard refer to this.

4. What can you tell me about production methods?

RNIB does not provide consultancy on the full range of production methods. However, we can often signpost innovative production methods when they are brought to our attention. Current methods include screenprinting and building embossing into the cut and crease process. Be aware that technology is moving on quickly and so it is worth reviewing your options regularly, particularly during the first few years of implementation.

RNIB does have extensive expertise on assessing the end product. That is, if you find a method that works for you, we will provide you with a service for assessing the physical braille on your packs.

We strongly recommend that you incorporate quality checking throughout the production process. Pharmaceutical companies should also ensure they work closely with the packaging suppliers to agree processes.

You are recommended to look at our Technology page, "How do I produce braille" to read about translation software and download the relevant factsheet

5. 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 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

6. 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.

7. Where can I find the names of RNIB equivalent organisations overseas

Please search our online database or the EBU webpage for details of other organisations.

Contact information

How to implement the EU Directive or to discuss RNIB services for organisations:

RNIB Business Development Team
RNIB Innovation and Disability Access Services
PO Box 173
Peterborough
PE2 6WS
Tel: 01733 37 53 45
Fax: 01733 37 53 79
Email: busdev@rnib.org.uk

If your question is related to RNIB's campaigning activity:

RNIB Public Policy Team
105 Judd Street
London
WC1H 9NE
Tel: 020 7391 2123
Fax: 020 7388 2706
Email: eurocampaigns@rnib.org.uk

If your question is related to the pharmaceutical industry guidance:

MHRA Medicines and Healthcare products Regulatory Agency

Information Centre
10-2 Market Towers
1 Nine Elms Lane
London
SW8 5NQ
Tel: 020 7084 2000
Email: info@mhra.gsi.gov.uk

You can also read the paper about the Commission guidance (PDF), online.

Other ways we can help

For companies who want to go beyond the legislation and to better meet the needs of their blind and partially sighted customers, we offer a range of services including

• Disability Awareness Training
• Visual Awareness Training
• Accessible Packaging Workshops (covering visual as well as tactile design)
• Support for employers and employees
• Website accessibility consultancy, audits and training

Content author: busdev@rnib.org.uk

Last updated: 22/07/2008 16:07