Article 14 · Commission Implementing Regulation (EU) 2024/1381

Contents

Article 14Draft joint clinical assessment and summary reports#

1.The assessor, with the assistance of the co-assessor, shall prepare the draft joint clinical assessment and summary reports using the templates set out in Annex II and Annex III. At any time during the preparation of the draft joint clinical assessment and summary reports, the assessor and/or co-assessor, via the HTA secretariat, may seek input from the patients, clinical experts and/or other relevant experts selected in accordance with Article 6. The HTA secretariat shall make that input available to the entire JCA Subgroup.

2.The HTA secretariat shall share the draft joint clinical assessment and summary reports prepared by the assessor, with the assistance of the co-assessor, for comments with the JCA Subgroup. After having considered the comments from the members of the JCA Subgroup, the assessor, with the assistance of the co-assessor, shall prepare the revised draft joint clinical assessment and summary reports.

3.The HTA secretariat shall share the revised draft joint clinical assessment and summary reports with the patients, clinical experts and other relevant experts selected in accordance with Article 6 and give them the opportunity to provide input on the revised draft joint clinical assessment and summary reports.

4.The HTA secretariat shall provide the revised draft joint clinical assessment and summary reports to the health technology developer. The health technology developer shall signal any purely technical or factual inaccuracies and any information it considers to be confidential within 7 days from the date on which it received the revised draft joint clinical assessment and summary reports. The health technology developer shall demonstrate the commercially sensitive nature of the information it considers to be confidential.The deadline referred to in the first subparagraph shall be 5 days from the date on which the health technology developer received the revised draft joint clinical assessment and summary reports where:

(a)the application for a marketing authorisation for a medicinal product is assessed under the accelerated procedure referred to in Article 14(9) of Regulation (EC) No 726/2004;

(b)the joint clinical assessment is conducted for a medicinal product referred to in Article 7(1), point (b), of Regulation (EU) 2021/2282, for which a variation to the terms of an existing marketing authorisation is of the type referred to in point 2(a) of Annex II to Regulation (EC) No 1234/2008 and corresponds to a new therapeutic indication; or

(c)a new assessment scope was developed during the joint clinical assessment, pursuant to Article 16 of this Regulation.

5.Where the health technology developer submits new clinical data on its own initiative under Article 11(2), third sentence, of Regulation (EU) 2021/2282, the JCA Subgroup shall ensure that the new clinical data is considered in the joint clinical assessment report, if received no later than 7 days after the adoption by the Committee for Medicinal Products for Human Use of its final opinion.