The common technical document (CTD) format is now mandatory for all submissions to European agencies. Shore personnel have, for some time, been involved in reviewing the CTD format and advising on the new table of contents and dossier content.
We offer a re-formatting service for old style EU dossiers. These re-formatted dossiers are not be subject to review by the agencies but provide the Company with a dossier that is in a state of readiness should a variation to the currently approved data be required.
The implementation of the new variations regulations, on 1 October 2003, makes the task of submitting variations more complex if the dossier is not in CTD format, as the dossier will have to be re-formatted at the same time as amending the data. We advise that re-formatting be undertaken in advance of any required change wherever possible.