(2003; 148 pages)
2.3 Screening of dossiers submitted
Each dossier submitted by the manufacturer will be screened for completeness prior to the evaluation of the dossier.
Dossiers that are incomplete will not be considered for evaluation. The manufacturer will be informed that an incomplete dossier has been received, and be requested to complete the dossier within a specified time period. In the event this is not complied with, the dossier will in principle be rejected on grounds of incompleteness and returned to the manufacturer.
Dossiers that are in compliance with the requirements of the WHO will be (a) retained for evaluation purposes and (b) the manufacturing site will be considered for a possible manufacturing site inspection (i.e. if warranted based on the outcome of the evaluation of the dossier.