BS EN 15823:2010 Packaging. Braille on packaging for medicinal products

BS EN 15823:2010

Packaging. Braille on packaging for medicinal products

Status : Superseded, Withdrawn   Published : July 2010 Replaced By : BS EN ISO 17351:2014

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BS EN 15823:2010 Packaging. Braille on packaging for medicinal products

BS EN 15823 is the standard aimed at supporting the implementation of Braille on medicinal products in the European Union (EU) and European Economic Area (EEA) and in particular, Chapter 2 of the associated European Commission Braille Implementation Guidelines [3].

BS EN 15823 specifies requirements and provides guidance for the application of Braille to the labelling of medicinal products.

The labelling of medicinal products placed on the market and incorporating Braille in accordance with BS EN 15823 meets the requirements of European Directive 2001/83/EC, Article 56, as amended by Directive 2004/27/EC [1].

The principles in this European Standard can be applied in other sectors, as appropriate.

Council Directive 2004/27/EC modifies the Community Legislation for medicinal products for human use (Directive 2001/83/EC [2]) and by subsequent incorporation into national legislation, introduces the need to include on the packaging of authorized medicinal products their names and, where appropriate, the form and strength in Braille as an aid to identification for blind and partially sighted people.

Contents of BS EN 15823 include:

  • Introduction
  • Scope
  • Terms and definitions
  • General requirements for medicinal product packaging
  • Product identification
  • Braille spacing convention
  • Braille character sets
  • Determination of Braille legibility
  • Principles of Braille legibility compliance
  • Braille cell dot height
  • Braille labelling
  • Methods of verification
  • Braille characteristics and recommendations
  • Technology for the application of Braille to packaging for medicinal
    products
  • Guidance on Braille specifications and artwork generation
  • Braille character sets
  • Bibliography

Read frequenty asked questions (FAQs) on the European Medicines Agency website.

Further information about Braille on labelling and in patient information leaflets can be read on www.mhra.gov.uk

 




Standard NumberBS EN 15823:2010
TitlePackaging. Braille on packaging for medicinal products
StatusSuperseded, Withdrawn
Publication Date31 July 2010
Withdrawn Date31 October 2014
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)2004/27/EC, 2001/83/EC
Replaced ByBS EN ISO 17351:2014
ReplacesDD 264:2007
International RelationshipsEN 15823:2010
Draft Superseded By08/30180499 DCDD 264:2007
DescriptorsPackaging, Packages, Drug containers, Drugs, Labels, Marking, Aids for the disabled, Blind people, Visually-impaired people, Braille, Legibility, Coded character sets
ICS11.120.99
11.180.30
55.020
Title in FrenchEmballage. Braille sur les emballages destinés aux médicaments
Title in GermanVerpackung. Blindenschrift auf Arzneimittelverpackungen
CommitteePKW/0/-/5
ISBN978 0 580 62679 1
PublisherBSI
FormatA4
DeliveryNo
Pages22
File Size384.8 KB
Price£130.00


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