Division 7 Mixed marketing authorisation applications

Mixed marketing authorisation applications are applications where Part(s) 3 and/or 4 of the dossier consist of safety and efficacy studies carried out by the applicant as well as bibliographical references. All other part(s) are in accordance with the structure described in Part 1 of Title I of this Annex. The competent authority shall accept the proposed format presented by the applicant on a case-by-case basis.