It has been mandatory to include Braille on all new EU Marketing Authorisations since 30th October 2005.
According to Article 56(a) of Council Directive 2001/83/EC it will be mandatory to include Braille on ALL EU pharmaceutical packaging by October 2010. This includes pharmaceutical products which were launched prior to October 2005.
Braille must show the name of the medicine and the appropriate strength, where more than one strength is available.
Braille alphabet
Support for Braille introduction
At Design Cognition we take the implementation of Braille very seriously. That is why our Chief Technical Officer Annie Dallison volunteered to be a member of The European Committee for Standardization (CEN) working group on Braille standards. Annie, as a leading industry expert, already had over 8 years of experience in the application of Braille on pharmaceutical packaging developing processes and establishing & setting standards for blue chip companies, making her an ideal member of the working group.
CEN working group
This CEN working group is made up of dedicated representatives from the packaging industry, trade associations, regulatory bodies and blind associations from across Europe.
This group has been working for over 3 years to determine and agree standards, including the Braille font style (Marburg medium) and measurement of Braille cell dot height that can be applied across the whole of the EU. One of the main issues for the team has been reaching agreement on the cell dot height that the blind associations feel will be sufficient to meet the needs of the blind users and also industry believe is commercially achievable. The final standard will hopefully be available before October 2010.
If you’d like find out more and how to avoid breaking the law, get your FREE ‘Introduction to Braille’ follow this link:
http://www.thepharmagateway.com/
If you are going to AAPS in Los Angeles, November 9th-12th, why not come & visit us at ‘Booth 1962′ to discuss this in more detail? See you there!
Chris Penfold
alfred says:
kenny says: