Taking a look at Braille implementation
Regular readers of this column will recall previous articles on the subject of the requirement set out in the EC Directive 2004/27/EC (amending the Medicines Directive 2001/83/EC) that (with certain exceptions) marketing authorisation holders must include the name of a medicinal product in Braille on its packaging.
Regular readers of this column will recall previous articles on the subject of the requirement set out in the EC Directive 2004/27/EC (amending the Medicines Directive 2001/83/EC) that (with certain exceptions) marketing authorisation holders must include the name of a medicinal product in Braille on its packaging.
This requirement came into force for new products in October 2005 and member states have implemented various provisions about application to existing products, with the UK requiring this on such products by October 2010.
Soon after the Directive was adopted moves began to seek to agree through a standard of the European standards organisation, CEN, norms for the physical characteristics of Braille used on medicinal products. A CEN group representing all stakeholders was formed in early 2006 to progress work on this project. Early this year this group finalised a draft document that CEN circulated in summer to its constituent members for public comment and which was issued in the UK by BSI as a draft for comment as document 08/30180499 DC BS EN 15823 - Packaging. Braille on packaging for medicinal products.
Details of how to obtain the draft are on the BSI website.
In particular, the document proposes parameters for the dot height of Braille for use on medicinal products. Comments are invited in the UK (to BSI) until the end of September 2008.
Once national comments have been sent to CEN they will be considered early next year by the latter's working group with a view to subsequently finalising a standard. This draft is obviously being closely scrutinised by pharmaceutical manufacturers and their carton and label suppliers and this column will update on progress with the development of the proposed standard.