1、PUBLISHED DOCUMENTPD CEN/TR 15753:2008Packaging Package leaflets for medicinal products Braille and other formats for visually impaired peopleICS 11.120.99; 11.180.30g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53
2、g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58PD CEN/TR 15753:2008This Published Document was published under the authority of the Standards Policy and Strategy Committee on 29 August 2008 BSI 2008ISBN 978 0 580 60795 0National forewordThis Published Document is the UK implementa
3、tion of CEN/TR 15753:2008.The UK participation in its preparation was entrusted by Technical Committee PKW/0, Packaging, to Panel PKW/0/-/5, Product Identification (Braille).A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not pu
4、rport to include all the necessary provisions of a contract. Users are responsible for its correct application.Amendments/corrigenda issued since publicationDate CommentsTECHNICAL REPORTRAPPORT TECHNIQUETECHNISCHER BERICHTCEN/TR 15753June 2008ICS 11.120.99; 11.180.30English VersionPackaging - Packag
5、e leaflets for medicinal products - Braille andother formats for visually impaired peopleEmballages - Notices de mdicaments - Ecriture en brailleou autres formats pour personnes malvoyantesVerpackung - Gebrauchsinformation fr Arzneimittel -Blindenschrift und andere Formate fr sehbehinderteMenschenTh
6、is 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, Ital
7、y, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Br
8、ussels 2008 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. CEN/TR 15753:2008: E2 Contents Page Foreword3 Introduction .4 1 Scope 5 2 Terms and definitions .5 3 Package leaflet alternative formats6 3.1 Legislated requirement .6 3.2 Gene
9、ral issues .6 3.3 Local Requirements 6 4 Alternative package leaflet formats, critical control points 7 Bibliography 9 CEN/TR 15753:20083 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 i
10、s 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. CEN/TR 15753:20084 Introduction Community legislation for medicinal products for human use is inc
11、luded 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 informat
12、ion 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 sup
13、port 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). CEN/TR 15753:20085 1 Scope This European Technical Report addresses the provision of information for m
14、edicinal 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 packa
15、ged 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 contraction
16、s 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 o
17、r 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 b
18、e 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 CEN/TR 15753:2008
19、6 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 alternativ
20、e 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 representa
21、tives 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 fi
22、les 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 p
23、rocedures. 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 comp
24、rehensively 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 MA
25、H is advised to set up and maintain protocols that ensure that these resources are updated and maintained in accordance with the local markets regulatory requirements with respect to change control, etc. Close co-operation is advised between MAH and organizations representing visually impaired peopl
26、e as to the exact requirements of each market. 3.3 Local Requirements The Braille character set, spacing and dot height should be in accordance with local requirements. NOTE For examples of local requirements, see 4 CEN/TR 15753:20087 4 Alternative package leaflet formats, critical control points Ta
27、ble 1 contains suggested critical control points, which should be considered when supplying alternative format package leaflets. Where the MAH is outsourcing this activity, agreements should be in place to ensure the critical control points are incorporated. This should not be considered as a checkl
28、ist for auditors. Table 1 Alternative package leaflet formats - critical control points Stage Process Critical control points General Media considered: Braille; Large print; Audio and electronic formats e.g.: synthesized voice over computer/ web; cassette tape; CD; telephone synthesized voice; telep
29、hone person; other formats. Whole system process validation/assurance is recommended. Quality Assurance is preferable, but if not possible the appropriate Quality Control procedures should be in place. An audit trail is essential. Origination Approved text issued by MAH. Standard Operating Procedure
30、s (SOPs) / Work instructions in place to ensure up-to-date text is used. Translation into preferred medium Whole process validation / assurance is recommended. Quality Assurance is preferable, but if not possible the appropriate Quality Control procedures should be in place. Translation into an appr
31、opriate computer file format, e.g. .txt or .xml might precede translation into preferred medium for some formats. There are good practice design documents available for many media. This includes layout. Some examples of these documents are given in the bibliography. Example Braille translation softw
32、are might not be fully capable of validation to Good Automated Manufacturing Practice (GAMP) 5 standard, so use of QA checks is more appropriate. For audio output media, checking of pronunciation of unusual / technical words is vital. For human-read audio output, training SOPs / work instructions ar
33、e highly recommended. If contracted Braille is used, care should be taken to avoid confusion/potential safety issues with abbreviations. CEN/TR 15753:20088 Table 1 (continued) Stage Process Critical control points Production and transfer to patient Timely production in chosen medium and timely distr
34、ibution. SOPs / work instructions and training. Process to ensure the patient receives the correct leaflet in the medium requested (e.g. does not receive “audio” if “large print” requested and available). Appropriate line clearance. Destruction of obsolete materials. Full traceability of any Braille
35、 tooling. Test procedure to assure pins active, etc. in Braille embossers. Braille production should be in accordance with local requirements. Validation/ verification/ quality control Whole process validation/ assurance is recommended. Quality Assurance is preferable, but if not possible the approp
36、riate Quality Control procedures should be in place. Appropriate sample retention. Example QA checks of Braille printouts. Appropriate sample retention. Change control Control of release onto market to ensure current version of authorized text is used. SOPs/ Work instructions for this in place to en
37、sure current version is used. Good practice timing to coincide with release of manufactured packs from the packing manufacturer with the new package leaflet (recognising that there are always some hard copies of old leaflets on the market with physical packs because of shelf life). Retention and arc
38、hiving of appropriate samples/records to track changeover dates is essential. CEN/TR 15753:20089 Bibliography 1 Directive 2001/83/EC as amended. http:/ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/consol_2004/human_code.pdf 2 European Commission, “Guidance concerning the Braille requirement
39、s for labelling and the package leaflet. Article 56a of Directive 2001/83/EC as amended” http:/ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2005/04_05/braille_text20050411.pdf 3 European Commission, “Draft Guideline on the readability of the label and package leaflet of medicinal produc
40、ts for human use”, revision September 2006 http:/ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2006/09_2006/readability_consultation_2006_09_25.pdf 4 Examples of local requirements for Braille character set, spacing and dot height: Braille Spacing Conventions (Marburg Medium, Marburg Lar
41、ge) http:/www.blista.de/download/druckerei/braille-dimensions.pdf German Braille System “Das System der deutschen Blindenschrift” ISBN 978-3-089642-022-0 http:/www.blista.de/download/druckerei/system_d_blindenschrift_7620.pdf DIN 32976 (2007) Braille - Requirements and dimensions (DIN 32976 “Blinden
42、schrift - Anforderungen und Mae.“ Entwurf vom August 2006) “Guas de la Comison Braille Espaola: Signografa Bsica”, Primera edicon, Organizacin Nacional de Ciegos Espaoles, Direccin de Cultura y Deporte, Departamento de Recursos Culturales Madrid, 2005. ISBN (13): 978-84-484-0155-9. ISBN (10): 84-484
43、-0155-7 “British Braille: A restatement of Standard English Braille Compiled and Authorized by the Braille Authority of the United Kingdom” http:/www.bauk.org.uk/docs/bbnew.pdf - NF Q 67-006 : 1985 “Technologie graphique - Spcifications typographiques recommandes pour limpression “braille” des livre
44、s scolaires” -NF Q67-004 : 1983 “Technologie graphique - Spcifications typographiques recommandes pour les dficients visuals” - Code de transcription en Braille des textes imprims (janvier 2006) : http:/www.avh.asso.fr/rubriques/infos_braille/dwnld/Code%20de%20transcription%202006%20A4.pdf Guidance
45、on the Braille marking in Finland is given by Finnish Federation of the Visually Impaired (FFVI), homepage http:/www.nkl.fi/yleista/english.htm. Guidance given in Finnish can be found at: http:/www.nkl.fi/tiedons/pistekirj/index.htm CEN/TR 15753:200810 5 The Good Automated Manufacturing Practice (GA
46、MP 4) Guide for Validation of Automated Systems in Pharmaceutical Manufacture: http:/www2.ispe.org/eseries/scriptcontent/orders/OrderSearchResults.cfm?contentarea=GAMP Further information Further information can be obtained from the sources given below. This list is not exhaustive and the informatio
47、n available given should not necessarily be treated as authoritative. Any proposed action taken using such information should be checked against local regulatory requirements. General information: European Blind Union “Guidelines Regarding Implementation of the European Union Directive on Medicinal
48、Products for Human Use: Package Information Leaflets (or Patient Information Leaflets) (PIL) Accessible for Visually Impaired End-Users” http:/www.euroblind.org/fichiersGB/pil-guid.htm Readability and accessibility: “European Blind Union Access to Information Guidelines” http:/www.euroblind.org/fich
49、iersGB/nl42.htm#announ Tiresias Guidelines: “Instruction Books” http:/www.tiresias.org/guidelines/access-ability/Access-Ability.htm#instructionbooks American Council of the Blind “A Guide to Making Documents Accessible to People Who Are Blind or Visually Impaired”, Jennifer Sutton http:/www.acb.org/accessible-formats.html Medicines and Healthcare products Regulatory Agency: Committee on Safety of Medicines “Always Read The Leaflet: Getting t
