1、PUBLISHED DOCUMENT PD CEN/TR 15753:2008 Packaging Package leaflets for medicinal products Braille and other formats for visually impaired people ICS 11.120.99; 11.180.30 PD CEN/TR 15753:2008 This Published Document was published under the authority of the Standards Policy and Strategy Committee on 2
2、9 August 2008 BSI 2008 ISBN 978 0 580 60795 0 National foreword This Published Document is the UK implementation 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 organi
3、zations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Amendments/corrigenda issued since publication Date CommentsTECHNICAL REPORT
4、RAPPORT TECHNIQUE TECHNISCHER BERICHT CEN/TR 15753 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 mdicaments - Ecriture en braille ou autres formats pour personnes
5、 malvoyantes Verpackung - Gebrauchsinformation fr Arzneimittel - Blindenschrift und andere Formate fr 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 Austri
6、a, 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 COMMIT
7、TEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN/TR 15753:2008: E2 Contents Page Fore
8、word3 Introduction .4 1 Scope 5 2 Terms and definitions .5 3 Package leaflet alternative formats6 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 CEN/TR 15753:20083 Foreword This document (CE
9、N/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 iden
10、tifying any or all such patent rights. CEN/TR 15753:20084 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 n
11、ames 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 labe
12、l 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)
13、and European Economic Area (EEA). CEN/TR 15753:20085 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 t
14、erms 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 ou
15、t 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
16、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
17、 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 tra
18、il systematic examination of processes and records to demonstrate compliance with requirements and applicable guidance CEN/TR 15753:20086 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
19、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 reques
20、t 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 t
21、he 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 fi
22、les, 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
23、 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 complet
24、es 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 the local markets regulatory requiremen
25、ts with respect to change control, etc. Close co-operation is advised between MAH and organizations representing visually impaired people 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 requireme
26、nts. NOTE For examples of local requirements, see 4 CEN/TR 15753:20087 4 Alternative package leaflet formats, critical control points Table 1 contains suggested critical control points, which should be considered when supplying alternative format package leaflets. Where the MAH is outsourcing this a
27、ctivity, agreements should be in place to ensure the critical control points are incorporated. This should not be considered as a checklist for auditors. Table 1 Alternative package leaflet formats - critical control points Stage Process Critical control points General Media considered: Braille; Lar
28、ge print; Audio and electronic formats e.g.: synthesized voice over computer/ web; cassette tape; CD; telephone synthesized voice; telephone person; other formats. Whole system process validation/assurance is recommended. Quality Assurance is preferable, but if not possible the appropriate Quality C
29、ontrol procedures should be in place. An audit trail is essential. Origination Approved text issued by MAH. Standard Operating Procedures (SOPs) / Work instructions in place to ensure up-to-date text is used. Translation into preferred medium Whole process validation / assurance is recommended. Qual
30、ity Assurance is preferable, but if not possible the appropriate Quality Control procedures should be in place. Translation into an appropriate computer file format, e.g. .txt or .xml might precede translation into preferred medium for some formats. There are good practice design documents available
31、 for many media. This includes layout. Some examples of these documents are given in the bibliography. Example Braille translation software 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 m
32、edia, checking of pronunciation of unusual / technical words is vital. For human-read audio output, training SOPs / work instructions are 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
33、(continued) Stage Process Critical control points Production and transfer to patient Timely production in chosen medium and timely distribution. 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
34、 “large print” requested and available). Appropriate line clearance. Destruction of obsolete materials. Full traceability of any Braille tooling. Test procedure to assure pins active, etc. in Braille embossers. Braille production should be in accordance with local requirements. Validation/ verificat
35、ion/ quality control Whole process validation/ assurance is recommended. Quality Assurance is preferable, but if not possible the appropriate Quality Control procedures should be in place. Appropriate sample retention. Example QA checks of Braille printouts. Appropriate sample retention. Change cont
36、rol Control of release onto market to ensure current version of authorized text is used. SOPs/ Work instructions for this in place to ensure current version is used. Good practice timing to coincide with release of manufactured packs from the packing manufacturer with the new package leaflet (recogn
37、ising that there are always some hard copies of old leaflets on the market with physical packs because of shelf life). Retention and archiving 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/
38、enterprise/pharmaceuticals/eudralex/vol-1/consol_2004/human_code.pdf 2 European Commission, “Guidance concerning the Braille requirements 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/
39、braille_text20050411.pdf 3 European Commission, “Draft Guideline on the readability of the label and package leaflet of medicinal products for human use”, revision September 2006 http:/ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2006/09_2006/readability_consultation_2 006_09_25.pdf 4 E
40、xamples of local requirements for Braille character set, spacing and dot height: Braille Spacing Conventions (Marburg Medium, Marburg Large) 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
41、.blista.de/download/druckerei/system_d_blindenschrift_7620.pdf DIN 32976 (2007) Braille - Requirements and dimensions (DIN 32976 “Blindenschrift - Anforderungen und Mae.“ Entwurf vom August 2006) “Guas de la Comison Braille Espaola: Signografa Bsica”, Primera edicon, Organizacin Nacional de Ciegos E
42、spaoles, Direccin de Cultura y Deporte, Departamento de Recursos Culturales Madrid, 2005. ISBN (13): 978-84-484-0155-9. ISBN (10): 84-484-0155-7 “British Braille: A restatement of Standard English Braille Compiled and Authorized by the Braille Authority of the United Kingdom” http:/www.bauk.org.uk/d
43、ocs/bbnew.pdf - NF Q 67-006 : 1985 “Technologie graphique - Spcifications typographiques recommandes pour limpression “braille” des livres scolaires” -NF Q67-004 : 1983 “Technologie graphique - Spcifications typographiques recommandes pour les dficients visuals” - Code de transcription en Braille de
44、s textes imprims (janvier 2006) : http:/www.avh.asso.fr/rubriques/infos_braille/dwnld/Code%20de%20transcription%202006%20A4.pdf Guidance 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
45、Finnish can be found at: http:/www.nkl.fi/tiedons/pistekirj/index.htm CEN/TR 15753:200810 5 The Good Automated Manufacturing Practice (GAMP 4) Guide for Validation of Automated Systems in Pharmaceutical Manufacture: http:/www2.ispe.org/eseries/scriptcontent/orders/OrderSearchResults.cfm?contentarea=
46、GAMP Further information Further information can be obtained from the sources given below. This list is not exhaustive and the information available given should not necessarily be treated as authoritative. Any proposed action taken using such information should be checked against local regulatory r
47、equirements. General information: European Blind Union “Guidelines Regarding Implementation of the European Union Directive on Medicinal Products for Human Use: Package Information Leaflets (or Patient Information Leaflets) (PIL) Accessible for Visually Impaired End-Users” http:/www.euroblind.org/fi
48、chiersGB/pil-guid.htm Readability and accessibility: “European Blind Union Access to Information Guidelines” http:/www.euroblind.org/fichiersGB/nl42.htm#announ Tiresias Guidelines: “Instruction Books” http:/www.tiresias.org/guidelines/access-ability/Access-Ability.htm#instructionbooks American Counc
49、il 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 the best information with every medicine” http:/www.mh
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