Once a dossier has been submitted, and the completeness check fee paid, the Rapporteur Member State (RMS) will carry out a completeness check. This should normally be done within 3 months, although the time period can be extended to 6 months if discussions with Other Member States (OMS) are required and the EU Commission (COM) has been informed of this.
A completeness check is a review of the dossier to establish whether all data endpoints have been addressed by either a study or scientific justification. The RMS does not normally assess the quality of the data/justifications, so issues may occur later during evaluation if data/justifications are subsequently found to be inadequate. Any substance read-across arguments presented are assessed to determine whether they are acceptable, as if they are not sufficiently robust the resultant data gaps will make the dossier incomplete.
If a dossier is found to be incomplete, the RMS will inform the applicant of any outstanding issues required before completeness can be achieved, and issues that need to be addressed before evaluation. The applicant is required to address any outstanding issues related to completeness within a month, or the dossier is deemed incomplete.
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