ABPI news: May 2005

Further light has recently been shed on the regulatory expectations in respect of the application of the Braille provisions of the 'New Medicines Legislation' (Directive 2004/27/EC).

On 12 April the European Commision issued its 'Guidance concerning the Braille requirements for labelling and the package leaflet' (available at http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/04_05/Braille_text20050411.pdf ).

In late March the Medicines and Healthcare products Regulatory Agency (MHRA) published its consultation (MLX 317) on the application of Directive 2004/27/EC (available at http://medicines.mhra.gov.uk/inforesources/publications/mlx317.pdf), which included its proposals for implementing the Braille requirements in the UK. Consultation on this document lasts until 16 June.

The European Commission's document is the result of two rounds of consultation with interested parties, and defines its requirements for the application of Braille to product packaging and the provision of information to the blind and partially sighted.

The new requirements will be applied to all products authorised after 30 October, with the information provisions applying to all products for which an application is made and approved after that date. MLX 317 proposes application of both the packaging and information requirements to products for which an application is made and approved after 30 October.

As regards existing products, the Commission Guidance says that they are not immediately covered, but it encourages application to them and seems to leave consideration of any legal requirement in this respect to national authorities. MLX 317 proposes a five year implementation period for existing products.

For blind people, aurally perceptible formats are recommended for transmission of information.

ABPI is scrutinising both documents closely and will be responding to MHRA by the due date on its proposals.