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
09-Sep-2008
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
08-Sep-2008
Due Date
13-Nov-2008
Completion Date
10-Sep-2008

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SIST-TP CEN/TR 15753:2008
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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.

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SIST-TP CEN/TR 15753:2008
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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

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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.

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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 label and

package leaflets of medicinal products for human use is also available [3]).

This European Technical Report provides guidance to support the requirement to provide the package leaflet

in alternative formats for blind and partially sighted people for medicinal products in the European Union (EU)

and European Economic Area (EEA).
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SIST-TP CEN/TR 15753:2008
CEN/TR 15753:2008 (E)
1 Scope

This European Technical Report addresses the provision of information for medicinal products in alternative

formats suitable for blind and partially sighted people.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
marketing authorization holder (MAH)

natural or legal person or entity responsible for placing the packaged medicinal product on the market

2.2
Braille
tactile reading and writing system composed of Braille cells
2.3
Braille cell
series of up to six raised dots set out in a domino-type cell
2.4
contracted Braille
Grade 2 Braille

braille that uses short forms of some commonly used words and contractions of commonly used letter

combinations rather than full spelling of all words
2.5
uncontracted Braille
Grade 1 Braille

braille where normally one cell represents a single letter, number, symbol, punctuation mark or an instruction

to the Braille reader

NOTE There is no abbreviation of letter groups or words and full spelling of words is used.

2.6
package leaflet (PL)
patient information leaflet (PIL)
text approved by a relevant competent authority for inclusion with the product
2.7
quality assurance (QA)

part of quality management focused on providing confidence that quality requirements will be fulfilled

[ISO 9000:2005 3.2.11]
2.8
quality control (QC)
part of quality management focussed on fulfilling quality requirements
[ISO 9000:2005, 3.2.10]
2.9
audit trail

systematic examination of processes and records to demonstrate compliance with requirements and

applicable guidance
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SIST-TP CEN/TR 15753:2008
CEN/TR 15753:2008 (E)
2.10
line clearance
removal (line purge) of everything associated with the previous production run
[ISO 15378:2006, 3.28]

NOTE Typically, line clearance is carried out previous to production to prevent any error and/or cross-contamination.

[abbreviated from ISO 15378:2006]
3 Package leaflet alternative formats
3.1 Legislated requirement

The package leaflet (PL/PIL) is required to be available in a suitable format or formats for visually impaired

people on request by their representative organizations.

The choice of the appropriate media should be agreed by the MAH in consultation with representatives of

organizations of visually impaired people. The choice of format from those available is with the patient / end

user.

In many instances, it is likely that the leaflet is required to be available in the following formats:

a) Braille
b) Large print
c) Audio
d) Electronic text

Digital master files can be created from MAH-approved text using validated and controlled processes. These

master files should be verified and approved. From these digital master files, alternative formats of the patient

information can be produced and distributed, without undue delay, in accordance with specified procedures.

The European Commission Guidance [2] does not specify particular alternative formats that should be

available or their distribution mechanisms.
3.2 General issues

All package leaflets are required to be prepared for reformatting to suit the media type(s) and to make them

meaningful and comprehensively understood by the patient. It is recommended that an expert in this field

and/or appropriate organisations representing visually impaired people completes this work.

Any adaptations to diagrams or tables should be carried out by the MAH in conjunction with an expert in this

field. The MAH is advised to set up and maintain protocols that ensure that these resources are updated and

maintained in accordance with
...

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