Article 3, Paragraph 2. · Commission Implementing Regulation (EU) 2024/1381

Contents

2.With regard to the medicinal products referred to in Article 7(1), points (a) and (b), of Regulation (EU) 2021/2282, the European Medicines Agency shall inform the HTA secretariat of the following:

(a)submission of a valid application for marketing authorisation in accordance with Article 3(1) and Article 3(2), point (a), of Regulation (EC) No 726/2004, including the date on which the application for marketing authorisation was validated and the timetable for the initial evaluation during the centralised procedure;

(b)submission of a valid application for a variation to the terms of an existing marketing authorisation which corresponds to a new therapeutic indication in accordance with Regulation (EC) No 1234/2008, including the date on which the application for a variation to an existing marketing authorisation was validated and the timetable for the initial evaluation during the centralised procedure.