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CEN

CEN/TR 15753:2008

(Main)

Packaging - Package leaflets for medicinal products - Braille and other formats for visually impaired people

Packaging - Package leaflets for medicinal products - Braille and other formats for visually impaired people

This European Technical Report addresses the provision of information for medicinal products in alternative formats suitable for blind and partially sighted people.

Verpackung - Gebrauchsinformation für Arzneimittel - Blindenschrift und andere Formate für sehbehinderte Menschen

Dieser Europäische Technische Bericht beschreibt die Bereitstellung von Informationen für Arzneimittel in alternativen Formaten, die für blinde und sehbehinderte Menschen geeignet sind.

Emballages - Notices de médicaments - Ecriture en braille ou autres formats pour personnes malvoyantes

Le présent Rapport technique européen traite de la fourniture d’informations sur les médicaments dans des
formats adaptés aux personnes aveugles ou malvoyantes.

Embalaža - Navodila za uporabo zdravil - Braillova pisava in drugi formati za slabovidne

General Information

Status
Published
Publication Date
17-Jun-2008
ICS
11.120.99 - Other standards related to pharmaceutics
11.180.30 - Aids for blind or partially sighted people
Technical Committee
CEN/TC 261 - Packaging
Drafting Committee
CEN/TC 261/SC 5 - Primary packaging and transport packaging
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
18-Jun-2008
Due Date
08-Mar-2009
Completion Date
18-Jun-2008
Ref Project
SIST-TP CEN/TR 15753:2008 - Packaging - Package leaflets for medicinal products - Braille and other formats for visually impaired people

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TP CEN/TR 15753:2008
01-oktober-2008
Embalaža - Navodila za uporabo zdravil - Braillova pisava in drugi formati za
slabovidne
Packaging - Package leaflets for medicinal products - Braille and other formats for
visually impaired people
Verpackung - Gebrauchsinformation für Arzneimittel - Blindenschrift und andere Formate
für sehbehinderte Menschen
Emballages - Notices de médicaments - Ecriture en braille ou autres formats pour
personnes malvoyantes
Ta slovenski standard je istoveten z: CEN/TR 15753:2008
ICS:
11.120.10 Zdravila Medicaments
11.180.30 3ULSRPRþNLLQSULODJRGLWYH]D Aids and adaptations for
EUDQMH reading
SIST-TP CEN/TR 15753:2008 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST-TP CEN/TR 15753:2008

---------------------- Page: 2 ----------------------

SIST-TP CEN/TR 15753:2008
TECHNICAL REPORT
CEN/TR 15753
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
June 2008
ICS 11.120.99; 11.180.30

English Version
Packaging - Package leaflets for medicinal products - Braille and
other formats for visually impaired people
Emballages - Notices de médicaments - Ecriture en braille Verpackung - Gebrauchsinformation für Arzneimittel -
ou autres formats pour personnes malvoyantes Blindenschrift und andere Formate für sehbehinderte
Menschen
This Technical Report was approved by CEN on 11 April 2008. It has been drawn up by the Technical Committee CEN/TC 261.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 15753:2008: E
worldwide for CEN national Members.

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SIST-TP CEN/TR 15753:2008
CEN/TR 15753:2008 (E)
Contents Page
Foreword.3
Introduction .4
1 Scope .5
2 Terms and definitions .5
3 Package leaflet alternative formats.6
3.1 Legislated requirement .6
3.2 General issues .6
3.3 Local Requirements .6
4 Alternative package leaflet formats, critical control points .7
Bibliography .9

2

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SIST-TP CEN/TR 15753:2008
CEN/TR 15753:2008 (E)
Foreword
This document (CEN/TR 15753:2008) has been prepared by Technical Committee CEN/TC 261 “Packaging”,
the secretariat of which is held by AFNOR.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
3

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SIST-TP CEN/TR 15753:2008
CEN/TR 15753:2008 (E)
Introduction
Community legislation for medicinal products for human use is included in Directive 2001/83/EC [1] as
amended by Directive 2004/27/EC. This includes a requirement that on the outer packaging of authorized
medicinal products their names are provided in Braille as an identification aid for visually impaired people. It is
also a requirement to provide patient information in formats suitable for visually impaired people. European
Commission guidance is available [2]. (A draft European Commission guideline on readability of the la
...

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