The FDA shall complete assessments under this Annex of Member State authorities for human pharmaceuticals listed in Appendix 2 as set out in paragraph II.A.4 and according to the following schedule, provided that the FDA receives complete capability assessment packages for such authorities containing the information specified in paragraph II.A.1 of Appendix 4 according to the schedule set out in paragraph 1:
l'autorité soumet le dossier d'évaluation de la compétence à la FDA dans un délai de 40 jours suivant la réception par l'autorité de la liste des points à contrôler dans le dossier d'évaluation de la compétence.