ABPI news: October 2005

The implementation date for the provisions of EC Directive 2004/27 is 30 October and in manufacturing terms one of the most significant provisions of that Directive is the requirement for all packs to carry the name of the product in Braille.

Across the Europe Union there have been differing approaches to implementation by the various members states, particularly on how it relates to products currently undergoing the application process and to existing products. UK publication of the regulations implementing the Directive was expected at the end of September with guidance shortly after that. However, the expectation was that the requirements for the application of Braille would apply to all products authorised after the implementation date of 30 October.

The time period provided to enable companies to place all existing products in Braille packs is not known, but the previous consultation on implementation (MLX 317) suggested it would be five years.

Also the Directive makes provision for the availability of patient information in formats suitable for the blind and visually impaired, though not necessarily in Braille format, by the same date.

Obviously there is a great deal of concern in the run up to the implementation in trying to comply with the provisions in member states and also in complying with the myriad of nuances across the EU.

It is likely that the picture will not be complete by the implementation date, and that the process will be one of learning.

Within the UK, work has been initiated by BSi to promote among European stakeholders the need for a European standard for the application of Braille to packaging. This would provide manufacturers with a norm that could be used across the EU for parameters such as dot height, as well as rationalise for pharmaceutical purposes some of the variations in Braille formats in various states.

The current situation is moving quickly so as to enable companies to comply by the due date and updates will be given on any progress.