FAQ: Braille for pharmaceutical packaging

Q. Which medicines must have Braille on the packs?

A. All medicines which will be handled directly by patients require Braille.. Medicines such as injectable products which are administered by healthcare professionals need not have Braille applied. Other medicines encompassed by this exception will include radiopharmaceuticals, anaesthetics, and infusions. However, insulin products and peritoneal dialysis fluids which are handled by patient will have to comply.

Q. What information must appear in Braille on the pack?

A. The name of the medicine must appear in Braille on the package. Where only one strength of the product is authorised the strength may be omitted. In some circumstances where different pharmaceutical forms of the same medicine are available it is recommended that this information is also included. Inclusion of the generic name in addition to the invented name where relevant is encouraged, particularly for medicines which are available on prescription.

Q. 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. 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.

Q. Is Braille required on herbal medicines?

A. 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.

Q. Where on the labelling should the Braille text be located?

A. 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. Care will also be needed where non-statutory information is used for robotic picking systems to ensure that such information is not rendered useless by the placement of Braille. It is likely that once a particular means of applying Braille has been researched the affect it will have on readability of typed text will not change. Nevertheless, use of a suitable “white space” on the packaging where available, is considered preferable for the application of Braille text.

Q. Will Braille have to be applied to the immediate primary packaging of medicines?

A. The application of Braille should be to the secondary packaging. Blister strips for example will not be affected by these new provisions.

Q. Does Braille need to be applied to containers which are not subsequently enclosed in an outer carton—for example bottles?

A. 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.

Q. Which Braille format should I use for my packaging?

A. The guidance published by the European Commission recommends the use of Marburg Medium.

Q. Can I use contracted Braille?

A. 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.

Q. Will Braille have to be applied to sample packs?

A. No. Sample packs are not intend for use by patients and therefore will not need the application of Braille. Sample packs are intended for prescribers to familiarise themselves with the product and are not for patient use in pursuance of a prescription.

Q. What needs to be applied to small containers?

A. In the case of small volume packages (up to 10 ml) with limited space capacity, alternative means of providing Braille information may be considered, e.g. use of contracted Braille system or certain defined abbreviations or addition of supplementary “tab” label.

Q. How do I deal with packaging with multi-language labelling?

A. Where a product is supplied with multilingual packaging, the name has to be printed in all the different languages concerned. Companies are encouraged to use the same invented name for the same medicinal product to avoid patient confusion.