Library :
Ensuring Effective Implementation of Provisions on Accessible Pharmaceutical Labelling
This issue relates to Directive 2004/27/EC on the Community code relating to medicinal products for human use, also known as the "Pharmaceutical Review Directive".
Following on from the successful lobbying by the EBU/EU Liaison Commission members over the last two years, the amended Directive was finally published in Official Journal L136 on 30 April 2004. This means that the implementation process now begins in earnest. Member States have until 30 October 2005 to implement the directive into their national legislation.
This means that by this date, all medicine sold in the EU must have the product name in braille on the packaging and that alternative formats of the patient information leaflet found inside the box, must also be made available to "patients organisations" in alternative formats
The full text of Article 56 a is copied
below.
What action is needed now ?
It would be useful for EBU members to maintain the pressure on their governments and civil service at this stage to gain detail of how they intend to implement this directive in practice and to put their organisations forward as a source of expertise in this field. EBU members could encourage the Member States to go further than they are obliged to do by the directive, for example by setting up an internet or telephone information service from where consumers can request alternative formats of patient information leaflets. In particular, it would be useful to get answers to the following questions :
1. Does your government intend to oblige large print to also be used on the packaging ?
2. Does your government intend to set up a centralised web or telephone based information service ?
3. How will the system for requesting the patient information leaflets in alternative formats work in practice in your country ?
4. What does your government understand by the term "patients organisations" ?
5. Is your government consulting with blind and partially sighted people or their organisations to work out the practical details of implementation of these measures ?
Article 56 a
" The name of the medicinal product, as referred to in Article 54, point (a) must also be expressed in Braille format on the packaging. The marketing authorisation holder shall ensure that the package information leaflet is made available on request from patients' organisations in formats appropriate for the blind and partially-sighted."