1. What is this paper about ?
From the end of October 2005, it is mandatory for all pharmaceutical products for human use to be provided with Braille information on the package. For a more detailed description regarding timing for implementation of the provisions, see section 2 below. This paper intends to give some practical uniform advice on how to fulfil the requirements simply and satisfactorily.
According to Directive 2004/27/EC submitted by the European Union, mandatory requirements have been set out in Art. 56 which mean a giant improvement for blind and partially-sighted persons in that, from the end of October 2005, they will be able to determine by themselves information pertaining to pharmaceutical products, whether it be prescribed and provided by a pharmacy or sold over the counter. The requirement on the part of the user / patient is that he/she is able to read some Braille in order to acquire the information. Many blind and partially sighted people may not be able to read long texts in Braille, yet they depend on this format on signs, directions, foods etc.
The pharmaceutical directive applies to all medicinal products for human use intended to be placed on the markets in the Member States. All EU legislation relating to pharmaceutical products is covered under the EEA Agreement and so the EEA areas (Iceland, Liechtenstein and Norway) will also be implementing this directive.
The directive's Art. 56 has two separate provisions, one on the labelling of the package, 1st sentence, and on making the patient information leaflet (PIL) accessible to visually impaired users, 2nd sentence. This paper deals solely with the 1st requirement, namely the Braille labelling requirement.
2. What products do the directive requirements encompass ?
The Braille labelling requirements (and the other requirements on accessible information from the patient leaflet) are mandatory for all medicinal products authorized after 30th October, 2005. However, EBU believes that all medicinal products on the market for human consumption should, regardless of the above deadline, be provided with the information in Braille if at all possible.
As for medicinal products on the shelves of the pharmacies and other outlets, neither they are to be labelled with Braille information, unless the responsible parties consider it possible and a token of good will and extended service. From the point of view of persons with a visual impairment it would obviously be highly desirable, that in an interim period, some measures be taken to attach Braille information to the boxes to ensure that the spirit and intention of the directive requirements is transposed as widely as possible on a voluntary basis.
From 31st October, 2005, however, all new products must as an obligatory requirement carry the appropriate Braille labelling provided that the above certification requirements are met.
3. Who is responsible for providing the Braille labelling ?
As the directive is worded, it is the license holders (distributors / manufacturers) who will be responsible for covering all expenses related to the braille labelling process.
This could mean that the costs related to applying Braille as described below, should be covered by the commercial entities mentioned, while the practical work in choosing the text, designing the position and methods and the actual labelling process could be carried out by several parties:
- The firm itself / the packaging producer
- Through a sub-contract the Braille library or the national organization of the blind, provided that all expenses are covered by the legally responsible entity.
4. What information is to be provided ?
Art. 56, 1st sentence, hereinafter called the directive provision, states that the name of the product should be put in Braille on the out package. What the term "name" means is basically defined in Art. 54 A. This means that, as the directive goes, there would be cases where a simple name of the product in one or two words is far from sufficient. There may be cases where, according to the directive requirements, much more information is included in the name.
It is recognized that the size of the carton or package in which the pharmaceutical product is sold has a limited surface and that, therefore, it may be impossible to fit in all the information that the directive might require, if the standard size, spacing etc. of the Braille symbols, cf. below, is to be adhered to. For this reason, it is recommended:
- That name in Art. 56, first sentence is understood as the unambiguous and distinguishable brand name with additional indication of strength or dosage to specify the product as different from other similar products with different strengths or active substances.
- Any additional information providing detailed information about name, components in the product of active nature, expiry date etc. cf. Art. 54 A are to be provided in a different manner through the means set up according to the patient leaflet accessibility provision. The methods, formats etc. of such information provision will not be dealt with in this paper but in another paper submitted later in 2006.
5. Methods of brailling
There are several ways to provide the medicine package with the Braille labelling. Three methods are known and may be used according to available methods, equipment, and services.
a. Through embossing the carton
b. By using special fonts on printers that emit a substance that cumulated makes up dots on the surface of the carton
c. A separate embossed label that is stuck to the medicine carton subsequently.
6. Braille specifications
Braille is a system where characters are represented as dots in a basic block two dots wide and three dots high called a Braille cell. All characters are combinations of dots within this framework.
The countries within the coverage area of the directive have varying standards nationally as regards to the placing, spacing, and dimensions of the Braille dots.
This paper intends to give some specifications that should cover all national specifications in a fair average way. The intention is not to violate adopted national standards but to provide the industry with some directions that may be practical and operational not only in one country but transnationally.
EBU recommends that the specifications below are implemented wherever possible.
- Height of dot (ideally) : 0,5 mm +/- 5 per cent - not less than 0,2 mm
- Diameter of the base of the dot : 1,3 mm +/- 1,5 per cent
- Horizontal spacing between dots in a cell : 2,5 mm +/- 4 per cent
- Vertical spacing between dots in a cell : 2,5 +/- 4 per cent
- Spacing between cells (between identical dots) : 6,0 mm +/- 10 per cent
- Spacing between lines (between identical dots) : 10,1 mm +/- 9 per cent
Validation and quality control of brailled information
As representatives of persons across Europe with a visual impairment, that are likely to use braille, the EBU considers it of paramount importance that validation mechanisms are established to ensure that before braille on cartons or labels for pharmaceutical products is released, end-user organizations are consulted for quality control and legibility.
7. Representation of characters
- All names must be written in full (grade 1) Braille, meaning that no contractions are to be used.
- Uppercase indicators are omitted.
- The letters a-z are represented in Braille in the same way in all countries covered by the directive.
- Accented characters have to be written in Braille according to the national standard in the country / countries in which such accented characters are parts of the alphabet.
- Values given as numbers are to be given as follows :
Number sign: dots 3456 (indicating that the next character(s) are interpreted as digits) followed by any or more of the letters a-j which will be interpreted as 1-0.
8. Special characters
- The period, full stop or point (as indicating a decimal value) is given by the use of dot 3.
- The percentage sign is given as a two character sign: the letters pc (dots 1234 immediately followed by dots 14).
- Milligrams : a Two-letter contraction: the letters mg (dots 134 immediately followed by dots 1245).
- Micrograms : A three-letter contraction; The letters mcg (dots 134 followed by dots 14 followed by dots 1245).
9. Where can you get more information or seek consultation ?
For any inquiries or additional information, you may as a point of departure address the EBU Office in Paris :
58 Avenue Bosquet - 75007 Paris
Tel : + 33 1 47 05 38 20
Fax : +33 1 47 05 38 21
E-mail :
ebuoffice@euroblind.org
From the Office, you may be directed to resource persons in the national organization of the blind or other agencies, who might assist or serve as contact in the country in question.
Be aware that due to national braille code requirements, certain deviations from the above recommendations may apply in certain countries.
Annex
Wording of relevant provisions in the directive
Article 2.1 : This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.
Article 54 : 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.
Article 56a : The name of the medicinal product, as referred to in Article 54, point (a) must also be expressed in Braille format on the packaging. The marketing authorisation 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.