These questions and answers are intended to provide helpful advice in relation to the new requirements for Braille
on Pharmaceutical Packaging under article 56(a) of Council Directive 2001/83/EC (as amended). This document is
complementary to guidance issued by the European Commission and should
be read in conjunction with it. The guidance from the Commission is available in the
Guidance concerning the Braille requirements for
labelling and the package leaflet.
Q. Which medicines will be affected by these new provisions?
A. All medicines which will be handled directly by patients will have to comply
with this new provision. 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. 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.
Source: Medicines and Healthcare products Regulatory Agency
October 2005. |
