A variation is a change to the dossier of an authorised product. As
from 1 January 2010 changes to the file of an authorised
medicinal product should, in most cases, be communicated in
accordance with the guidelines of the Variation Regulation 1234/2008.
Human Medicine > Regulatory Affairs > Legislation and
guidelines > variations contains up-to-date information
regarding the communication of changes to files of authorised