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EU Directive 2004/27 article 56a

EU Directive 2004/27 article 56a. EU Directive 2004/27 article 56a , hvor langt er vi? Braille Hvor er vi henne som industri. Hvilke løsninger er vi nået til? Problemstillinger for 18 mdr. siden, vi nu har løst og nuværende. Tilgængelige PIL-tekster EU overblik.

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EU Directive 2004/27 article 56a

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  1. EU Directive 2004/27 article 56a • EU Directive 2004/27 article 56a, hvor langt er vi? • Braille • Hvor er vi henne som industri. • Hvilke løsninger er vi nået til? • Problemstillinger for 18 mdr. siden, vi nu har løst og nuværende. • Tilgængelige PIL-tekster • EU overblik Anette Molin & Peter Mardov-Egvang

  2. BrailleGuideline requirements 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.

  3. Hvor er vi henne som industri. • Fundet frem til hvordan braille skal udarbejdes • Kontrol & validering, standardiseret processerne (Flow) • Fået leverandørerne med, standardiseret processerne (Flow) samt Kontrol & validering.

  4. Hvilke løsninger er vi nået til? • Marburg Medium standard, som efterlever EU-direktiv krav • Grundet høje udgifter, har vi udarbejdet retningsliner for ensretning af placering af Braille.

  5. Problemstillinger for 18 mdr. siden, vi nu har løst og nuværende. • Etableret nationalt & europæisk netværk, bestående af blinde & medicinal industri. • -BSI Initiative Project No: 2005/ 02273 • Accepteret aktiv deltagelse i arbejdet med udarbejdelse af ISO standard i CEN regi. • -Developing a Standard – CEN working group 12 • Flere sproget pakninger (eks. nordiske lande, Belgien) • Ingen afklaring af LMS engagement i braille på mock-up’s/ tekster, alene Norge og Spanien, samt Irland har afklaret.

  6. Braille Cell Dimensions • The standard Braille cell consists of six dots in two columns of three dots.

  7. Braille alphabet chart

  8. Braille Alphabet Matrix

  9. Braille Alphabet Matrix EBU: (Also e.g.. Denmark, Latvia, Slovakia) France: New Unified French Braille, January, 2006 To download the full table, please visit http://www.avh.asso.fr/index.php?module=14&nameRub=nouveau_code&opt=0

  10. Braille on boxes and Quality Assurance

  11. Braille Cell Dimensions

  12. Create Braille artwork with font Marburg Medium or • Braille BQ size 25.75 • Create output film to generate dies and over layers • QA Check • Supply of dies • Cut and crease • QA check • Produce pack • Check print sheet with red or blue over layers • Measure Braille height with micro meter or similar • QA release of pack

  13. ….. Faldgruber • Observations throughout Europe, • the Braille text for the product strength did not differentiate between numbers • and letters, and as a result, the Braille text was not readily readable to a Braille user. • a decimal point in a product strength was incorrectly shown in Braille as a full stop. • the Braille text for multi-strength products did not clearly state the strength of each • product, as the units of measurement for the strength were missing. • the Braille dots on outer cartons were observed to be quite flat, and not easily read • by the Braille user.

  14. Hvad mangler vi som industri. • Europæisk braille matrix, alfabet(er) og mest anvendte special tegn • Matix accepteret af alle nationale blindeorganisationer • BSI og ISO standard • Fuld oversigt over medlemslandes implementering status

  15. Packaging Information LeafletGuideline requirements Upon request the package leaflet should be provided for partially sighted people in a suitable print. For blindpeople the text has to be provided in an appropriate format, provision of the text in a format perceptible by hearing.

  16. Packaging Information LeafletGuideline requirements It is the responsibility of the marketing authorisation holder to provide the package leaflet on request from patient organisation in an appropriate format to ensure the current versions are supplied. Choice of the appropriate medium should be made by the MAH in consultation with representatives of organisations for the blind and partially sighted.

  17. PIL for synshandikappede patienter • Media: CD-ROM, Audiocassette, Braille, Large Print • Developing ”good practice” for standardising to minimise costs • Telephone Support lines • Web based solutions* • RFID • Data sound • * http://www.oio.dk

  18. PIL for synshandikappede patienter • Status DK • Lægemiddel katalog • Firma hjemmesider • Firma informations afd. bede om at få PIL leveret som large print / audio • Store omkostninger ved Braille print (levering og kvalitetssikring) • Manglende afklaring vedr. officiel dato for hvornår alle indlægsedler bliver offentlig gjort på LMS hjemme side. LMS har som offentlig virksomhed krav til at informationer skal være tilgængelige for blinde & svagtseende (04.04.2006) • * http://www.oio.dk

  19. Quality Assurance of the PIL for the Partially sighted Patients- BSI development PDF format • SOP describing the internal processes and responsibilities Audio format • SOP describing the internal processes and responsibilities Braille format • QA contract covering aspects of the second control, translation of diagram's, order confirmation, training, documentation, etc. European Blind Organisation Guideline PIL for the Partially sighted Patients www.euroblind.org.uk

  20. Thank you – Any questions ?

  21. BrailleRecommendations from the European Blind Union • The intention is to provide the industry with some directions that may be practical and operational not only in one country but transnationally. • Height of dot (Ideally): 0,5 mm + / - 5 % (EBU requirements) • Diameter of the base of the dot: 1,3 mm + / - 1,5 % • Horizontal spacing between dots in a cell: 2,5 mm + / - 4 % • Vertical spacing between dots in a cell: 2,5 + / - 4 % • Spacing between cells (between identical dots): 6, 0 mm + / - 10 % • Spacing between lines (between identical dots): 10,1 mm + / - 9 %

  22. BrailleRecommendations from the European Blind Union • 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 characters) are interpreted as digits) followed by any or more of the letters a-j which will be interpreted as 1-0.

  23. BrailleRecommendations from the European Blind Union • 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: dot 5 followed by the letter p (dots 1234). • Microgrammes presented as mcg • Source: European Blind Union

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