Reminder to MAH to submit paediatric information in accordance with the requirements of the Paediatric Regulation

06 March 2008

On the 20 December 2007 the IMB published a notice to marketing authorisation holders on how to submit information regarding existing paediatric studies and paediatric uses. Completed templates were required by the 26 January 2008 for all authorised medicinal products and not just those products with a paediatric indication. Marketing authorisation holders that have not yet responded are reminded to do so immediately.

Further information on the requirements and templates are available at:

http://www.imb.ie/images/uploaded/documents/Paediatric%20Regulation%20Requirements.pdf