Article 3 · Commission Implementing Regulation (EU) 2024/1381

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Article 3Exchange of information with the European Medicines Agency#

1.The European Medicines Agency shall notify the HTA secretariat of the submission of an application for a marketing authorisation or for a variation to the terms of an existing marketing authorisation referred to in Article 2 of this Regulation upon receipt thereof.

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.

3.The European Medicines Agency shall provide the HTA secretariat with the information referred to in paragraph 2 on the day it issues the health technology developer the receipt of a valid application.

4.During the centralised procedure for medicinal products subject to a joint clinical assessment, the European Medicines Agency shall inform the HTA secretariat of the following:

(a)updates on steps in the centralised procedure, including changes in the envisaged timelines;

(b)substantial questions or outstanding issues that might impact the therapeutic indication(s) of the medicinal products proposed by the applicant.

Point (a) also applies to medicinal products of which the joint clinical assessment was discontinued pursuant to Article 10(6) of Regulation (EU) 2021/2282.The main steps for the exchange of the information referred to in the first subparagraph, as well as the exact content of the information to be communicated at those steps, shall be agreed upon by the European Medicines Agency, the HTA secretariat and the JCA Subgroup.

5.The European Medicines Agency shall send the draft summary of product characteristics and the assessment report referred to in Article 9(4), points (a) and (e) respectively, of Regulation (EC) No 726/2004 to the HTA secretariat at the latest within 7 days from the adoption by the Committee for Medicinal Products for Human Use of its final opinion.