New e-mail address for Paediatric Information

21.1.2008

Marketing Authorisation Holders shall submit Paediatric Information to relevant Competent Authorities witin the EEA, including the Icelandic Medicines Control Agency, in accordance to articles 45 and 46 in the Regulation EC/1901/2006.

Guidance on how the Marketing Authorisation Holders should submit the information is published on the CMD-h website. The IMCA requests that Marketing Authorisation Holders sends the information to the e-mail address: paed.data@imca.is or to the IMCA, Eidistorg 13-15, P.O.Box 180, 172 Seltjarnarnes, Iceland.