Article 15 · Commission Implementing Regulation (EU) 2024/1381

Contents

Article 15Finalisation of the revised draft joint clinical assessment and summary reports#

1.The JCA Subgroup shall discuss the revised draft joint clinical assessment and summary reports, as well as the input provided pursuant to Article 14(3) and (4), in a meeting. The JCA Subgroup, via the HTA secretariat, may invite patients, clinical experts and/or other relevant experts in a dedicated part of the meeting discussing the relevant revised draft reports.

2.The JCA Subgroup shall finalise the revised draft joint clinical assessment and summary reports at the latest on the date of the adoption of the Commission decision granting the marketing authorisation and submit them to the Coordination Group for endorsement.

3.Where the Coordination Group re-initiates a joint clinical assessment pursuant to Article 10(7) of Regulation (EU) 2021/2282 or initiates an update of a joint clinical assessment pursuant to Article 14 of Regulation (EU) 2021/2282, and no update of the assessment scope is necessary, the JCA Subgroup shall finalise the revised draft joint clinical assessment and summary reports within 180 days from the date of re-initiation of the joint clinical assessment or of the initiation of the update of the joint clinical assessment and submit them to the Coordination Group for endorsement.

4.Where the Coordination Group initiates an update of a joint clinical assessment pursuant to Article 14 of Regulation (EU) 2021/2282 and an update of the assessment scope is necessary, the JCA Subgroup shall validate the revised updated draft joint clinical assessment and summary reports within 330 days from the date on which the Coordination Group initiated the update of the joint clinical assessment. The JCA Subgroup shall submit the revised updated draft joint clinical assessment and summary reports to the Coordination Group for endorsement.

5.If the deadline specified in Article 11(1), point (a), of Regulation (EU) 2021/2282 does not apply, the Coordination Group shall endorse the revised draft joint clinical assessment and summary reports within 30 days from their receipt.