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.
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.
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.
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.
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.
The Braille must not be reduced in size to fit the pack. 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.
Most countries have their own braille code. There are some commonalities but there are some important differences. Although the Latin names may be the same across many markets this doesn’t guarantee that the same braille can be used. However, there are many instances where the same braille block can be used in more than one country. Please refer to the braille codes for each country before proceeding with standardization of Braille on packs.
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.
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. Use of a suitable “white space” on the packaging where available, is considered preferable for the application of Braille text.
The guidance for American Markets and the standards published by the European Commission recommend the use of Marburg Medium.
All medicines which will be handled directly by patients require Braille. Medicines such as injectable products, radiopharmaceuticals, anaesthetics etc., which are administered by healthcare professionals, need not have Braille applied.