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EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals ENTR/F2 D(2005) |
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EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Pharmaceuticals ENTR/F2 D(2005) |
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After
finalisation of the revision of the ‘GUIDELINE ON THE READABILITY OF THE LABEL
AND PACKAGE LEAFLET OF MEDICINAL PRODUCTS FOR HUMAN USE’ the guidance
concerning the Braille requirements will be included as part of this
readability guideline.
Directive 2004/27/EC – amending Directive 2001/83/EC - includes changes to the
label and package leaflet requirements.
This guidance interprets the requirements for Braille on the packaging, and
the requirements for the package leaflet to be made available in formats for
the blind and partially sighted according to Article 56a.
Directive 2001/83/EC as amended by Directive 2004/27/EC, Article 56 a
The name of the medicinal product, as referred to in Article 54 a must also be
expressed in Braille format on the packaging.
The marketing authorization holder shall ensure that the package information
leaflet is made available on request from patients organisations in formats
appropriate for the blind and partially-sighted.
Directive 2001/83/EC as amended by Directive 2004/27/EC, Article54 a
The name of the medicinal product, followed by its strength and pharmaceutical
form, and if appropriate, whether it is intended for babies, children or
adults; where the product contains up to three active substances, the
international non-proprietary name (INN) shall be included, or, if one does
not exist, the common name.
The provision of Article 56a will apply after the end of the implementation
period – 30 Oct 2005 – to all medicinal product approved after this date. It
will not apply immediately to products authorized before 30 October 2005.
Nevertheless companies are encouraged to apply the provision to all medicinal
products as soon as possible. For specific implementation requirements
reference is made to the relevant national legislation and EMEA guidance for
Centrally Authorised Products.
Braille is the internationally widespread reading and writing system for blind
and partially sighted people. The system was founded in 1825 by Louis Braille
(1809 – 1852), who lived in France and himself was blind.
Braille is not a language, it is just another way to read and write a
language.
Braille consists of arrangements of dots which make up the letters of the
alphabet, numbers and punctuation marks.
The basic Braille symbol is called the Braille cell.
Due to the reason that there are differences in Braille in different
countries, the type of Braille letter (size of Braille cell) has to be
standardized. The use of Marburg Medium is highly recommended.
The uncontracted Braille system should be used. In this system every Braille
character (Braille cell) makes up the letter of the alphabet, punctuation
mark, numbers, etc. The contracted Braille system with letter-combinations
should not be used, except in small volume packaging (up to 10 ml volume) –
see paragraph below under “Scope”.
“The name of the medicinal product, as referred to in Article 54a” should be
interpreted in a way which allows clear identification for blind people.
According to the definition in Article 1.20 of Directive 2001/83/EC as amended
“the name, which may be either an invented name not liable to confusion with
the common name, or a common or scientific name accompanied by a trade mark or
the name of the marketing authorization holder”, the (invented) name of the
medicinal product followed by its strength should be put in Braille on the
packaging of the product.
For medicinal products authorised only in a single strength, it is acceptable
that only the invented name in Braille is put on the packaging.
This interpretation does not prevent companies to express further information
(pharmaceutical form, and if appropriate, whether it is intended for babies,
children or adults, etc) in Braille on bigger volume packages on a voluntary
basis. Also the inclusion of the expiry date in Braille would be welcome,
although it is acknowledged that this may not always be feasible.
For Herbal Medicinal Products the Braille requirement will be restricted to
the invented name of the Medicinal Product only. Where the name consists of
the active substance(s), information could be limited to the plant name (+
plant part in those cases where several
parts are available), plus the type of preparation and the strength in those
cases where several strengths exist.
In case of small volume packages (up to 10 ml) with limited space capacity,
alternative means of providing Braille information may be considered, eg. use
of contracted Braille system or certain defined abbreviations or addition of
supplementary “tab” label. Particular consideration should be given to
medicinal products likely to be used by a high visually impaired target
population, eg. certain eye drop preparations.
In case of multilingual packaging, the name in Braille has to be printed in
all the different languages concerned. Companies are encouraged to use the
same invented name for the same medicinal product.
There is no need to put the name in Braille on the packaging of products which
are only intended for administration by health care professionals, for example
it is not required to put the name in Braille for vaccines.
The name in Braille does not have to be printed on the immediate packaging -
such as blisters, ampoules and bottles, it only has to appear on the
outer/secondary packaging, which is normally a carton. In case where there is
no secondary packaging, eg. Large volume bottles (500 ml, 1000 ml, etc.), it
is possible to fix an adhesive Braille label around the bottle during the
manufacturing process.
On a volunteer basis companies can put the name in Braille on all packaging
components.
Affixing an adhesive Braille label at the point of sale/dispensing of the
medicinal product on request is not recommended, due to the risk of affixing
the wrong Braille label and confusion.
Concerning the location of the Braille on the outer packaging there is no need
to put the Braille dots on an empty space of the packaging, but the underlying
printed text has to be easily legible.
Where Braille is present on the (outer) packaging of a medicinal product,
parallel importer/parallel distributor should ensure that the same Braille
text is provided in the language(s) of the member state of destination and
that the original Braille text will not cause confusion.
On request the package leaflet should be provided for partially sighted people
in a suitable print, taking into consideration all aspects determining the
readability (eg. Fontsize: Sans serif typefaces , 16 - 20 point, contrast:
black letters on white paper, word spacing, text alignment, line spacing,
layout, paper quality ). For blind people the text has to be provided in an
appropriate format , it is recommended to provide the text in a format
perceptible by hearing (CD-ROM, audiocassette, etc.). In certain cases the
appropriate format may be the package leaflet available in Braille.
Choice of the appropriate medium should be made by the MAH in consultation
with representatives of organizations for the blind and partially sighted. It
is the responsibility of the marketing authorization holder to provide the
package leaflet on request from patients organizations in an appropriate
format and to ensure that the current version is supplied.
This provision of Article 56a will apply after the end of the implementation
period – 30 October 2005 – to all medicinal product marketing authorization
applications approved after this date. It will not apply immediately to
products authorized before 30 October 2005.
Nevertheless companies are encouraged to apply the provision to all medicinal
products as soon as possible. For specific implementation requirements
reference is made to the relevant national legislation and EMEA guidance for
Centrally Authorised Products.
These requirements concerning the package leaflet for blind and partially
sighted persons also fully apply to parallel importers/distributors.