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

Anette Molin & Peter Mardov-Egvang

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.

3IFF 25.01.2007 | Thursday 20 April 2023

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.


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.


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.


Braille Cell Dimensions

The standard Braille cell consists of six dots in two columns of three dots.


Braille alphabet chart


Braille Alphabet Matrix

Signs Spain Italy Germany Great Britain France

EBU (proposed standard)

. (full stop)


Braille Alphabet Matrix

France: New

Unified French Braille,

January, 2006

EBU:(Also e.g.. Denmark, Latvia, Slovakia)

To download the full table, please visit http://www.avh.asso.fr/index.php?module=14&nameRub=nouveau_code&opt=0


Braille on boxes and Quality Assurance


Braille Cell Dimensions


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


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.

….. Faldgruber


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

Packaging Information LeafletGuideline requirements

Upon request the package leaflet should be provided for partially sighted people in a suitable print.

For blind people the text has to be provided in an appropriate format, provision of the text in a format perceptible by hearing.

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.


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


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


Quality Assurance of the PIL for the Partially sighted Patients

- BSI development

Braille format

Audio format

PDF format

SOP describing the internal processes and responsibilities

SOP describing the internal processes and responsibilities

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

Thank you – Any questions ?


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 %



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.



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

eu directive 2004/27 article 56a

Documents

braille text

braille dots

braille user

braille artwork

standard braille cell

layersmeasure braille

braille bq size

braille cell dimensions