SIST-TP CEN/TR 15753:2008

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
• ICS: 11.120.10 - Medicaments
• ICS: 11.180.30 - Aids for blind or partially sighted people
• Technical Committee: EPO - Packaging - sales and grouped
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 08-Sep-2008
• Due Date: 13-Nov-2008
• Completion Date: 10-Sep-2008
• Ref Project: CEN/TR 15753:2008 - Packaging - Package leaflets for medicinal products - Braille and other formats for visually impaired people

Overview

SIST-TP CEN/TR 15753:2008 provides practical guidance for the provision of medicinal product package leaflets (PL/PIL) in alternative formats suitable for blind and partially sighted people. The Technical Report supports the EU requirement (Directive 2001/83/EC and subsequent guidance) that medicinal information be accessible on request, and that names on outer packaging may be provided in Braille as an identification aid.

This guidance is aimed at marketing authorization holders (MAHs), packaging and printing suppliers, accessibility experts and organizations representing visually impaired people. It focuses on ensuring accurate, timely and controlled delivery of alternative formats such as Braille, large print, audio and electronic text.

Key Topics

• Formats covered: Braille (contracted and uncontracted), large print, audio (synthesized or human-read), cassette/CD, telephone-based services and electronic text files (.txt, .xml) as digital master files.
• Roles and responsibilities: MAHs must coordinate with representatives of visually impaired people to agree appropriate media and ensure the patient/end user chooses the preferred format.
• Quality and control: Emphasis on quality assurance (QA) or quality control (QC), whole-system validation/assurance where feasible, and an audit trail for traceability.
• Production controls: SOPs, work instructions, line clearance, retention of samples and verification of Braille embossing equipment are noted as critical control points.
• Change control: Processes to ensure the current authorized text is used when releasing alternative format leaflets, with archiving and sample retention to track version changes.
• Local requirements: Braille character set, spacing and dot height vary by country; MAHs must follow local standards and consult available guidance.

Applications

This Technical Report is practically applied where accessible patient information is required for safe and effective medicine use. Typical applications include:

• Preparing digital master files from MAH-approved text to enable rapid production of alternative formats.
• Outsourcing Braille transcription, audio recording or large-print layout under contractual arrangements that embed the critical control points described in the report.
• Implementing validation, QA/QC and audit trail processes to ensure consistent, compliant delivery of accessible leaflets across EU/EEA markets.

Benefits include improved accessibility for visually impaired patients, reduced risk of misinformation, and support for regulatory compliance and product safety.

Related Standards

• Directive 2001/83/EC (medicinal products for human use) and related EC guidance on Braille and leaflet readability.
• Good Automated Manufacturing Practice (GAMP) guidance for automated systems validation.
• National and international Braille and large-print guidance (examples cited in the report include DIN 32976 and national Braille codes).

For MAHs and suppliers, following SIST-TP CEN/TR 15753:2008 helps establish robust processes for producing accessible package leaflets while aligning with regulatory expectations and the needs of visually impaired end users.

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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

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.
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).
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
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
...