xmlns:atom="http://www.w3.org/2005/Atom" xmlns:atom="http://www.w3.org/2005/Atom"
Textual Amendments
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 I of Title I of this Annex. The competent authority shall accept the proposed format presented by the applicant on a case-by-case basis.]