It is now just over a year since the implementation of the requirements of EU Directive 2001/83/EC as amended by Directive 2004/27/EC, which stipulated the inclusion on packaging of medicinal products of the name of the product in Braille.
In the UK the implementation of the provisions applied immediately to products authorised after 30 October 2005 and to existing products within five years of that implementation date. However, there have been a variety of interpretations of the Directive requirements in EU member states that have been the cause of some concern to manufacturers.
Preceding the implementation of the legislation and also afterwards there has been a significant amount of guidance issued on compliance with the Directive. Apart from the EC guidance on application and also local regulatory guidance by national regulatory authorities, such as the Medicines and Healthcare products Agency (MHRA) in the UK, there have been a number of documents and local standards offering practical advice issued by various organisations and bodies.
These include standards organisations, carton manufacturers and bodies representing the visually impaired. Not surprisingly, there are some variations in detail and advice between these various publications.
In an effort to offer some consistent practical guidance across the EU, and at the instigation of BSi in the UK, there has been an initiative taken by the European standards organisation, CEN. It has charged one of its Working Groups to work towards developing a standard for Braille for use in pharmaceutical packaging that might be helpful to all stakeholders involved in ensuring that the provisions of the Directive are implemented as efficiently as possible across the Union.
The work of this Group got under way in July and continues and if it can come to a consensus on certain parameters relating to pharmaceutical Braille (e.g. readable dot height) it will be an extremely valuable contribution to consistent application of the legislation across Europe. This column will monitor and update on the progress of the Group's work.