Guidance documents
BROMI Variations Procedures
A joint MHRA & industry conference to launch the BROMI Variations Procedures was held on 8 May 2008. The following presentations and training materials from the conference are available to download:
- BROMI Variations - Presentation by Anne Ambose, MHRA
- Better Regulation, DH Simplification Plan and BROMI - Presentation by Chris Horsey, Head of Better Regulation at the Department of Health
- BROMI Variations: An industry perspective - Presentation by Helen Darracott, PAGB Dorector of Legal and Regulatory Affairs and Gill Peckham, Head of Regulatory Affairs, Johnson & Johnson
- BROMI Variations - Training presentation
- Case study presentation
BSi Braille Standard
Draft for development - DD 264:2007 Packaging. Braille and other formats for medicinal products
This can be purchased from the BSi website at www.bsi-global.com/dd264
Council Directive 2004/27/EC [1] modifies the Community Legislation for medicinal products for human use (Council Directive 2001/83/EC [2]), and by incorporation into national legislation introduces the need to include on the outer packaging of authorized medicinal products their names in Braille as an aid to identification for blind and partially sighted people.
DD 264 is primarily aimed at supporting the implementation of Braille on medicinal products in the European Union (EU) and European Economic Area (EEA) and in particular Part 1 of the associated European Commission Braille Implementation Guidance [3]. In addition to Braille on the labelling of the package, it supports the requirement to provide the package leaflet in formats for blind and partially sighted people.
The general principles in DD264 Draft for Development can be applied in other sectors, as appropriate.
Contents of DD 264:2007 include:
- Foreword
- Scope
- Terms and definitions
- General requirements for medicinal product packaging
- Product identification and legibility of labelling
Annexes
- Package leaflet alternative formats
- Alternative package leaflet formats, critical control points
- Braille characteristics and recommendations
- Braille critical control points
- Braille character sets
- Braille verification
- Technology for the application of Braille to packaging for medicinal products
- Braille specifications and artwork generation
- Bibliography
List of figures
- The Braille cell
- Braille text representation
- Marburg medium spacing convention for Braille
- Braille transposition of letters in common use
- Principle of embossing
- Example of Braille positioning on a carton
- Approved artwork proof
- List of tables
- Alternative package leaflet formats, critical control points
- Braille artwork/origination
DD 264, the Draft for Development was published by BSI and came into effect on 31 July 2007.