Packaging and Labelling ...

The requirements set out by both the CHMP and national agencies, for the submission of packaging information to accompany applications, are constantly changing. The latest CHMP review of the guidance on packaging information was published in March 2005 and lays out the requirements to enable authorisation to be granted by the Community.

It is also now a requirement for product information to be harmonised following the Mutual Recognition and Decentralised Procedures. The MRFG group has published a concept paper for achieving harmonised patient information.

National requirements must also be taken into consideration and these can now be accommodated using the ‘Blue Box’ concept similar to that used for products authorised through the Centralised Procedure.

In addition, the requirement for the provision of Braille on the packaging, the need for user testing and the requirements for the package leaflet to be made available in formats for the blind and partially sightedcanbe a mine field!

Shore personnel have extensive knowledge of labelling and packaging requirements and offer advice and assistance on creating labelling and leaflets for new applications as well as updating existing labelling to accompany variations, line extensions and renewal applications