Contents
Article 10Finalisation of the assessment scope#
1.The JCA Subgroup shall discuss the consolidated assessment scope proposal referred to in Article 9(2), as well as the input of patients, clinical experts and other relevant experts during an assessment scope consolidation meeting. The JCA Subgroup, via the HTA secretariat, may invite patients, clinical experts and other relevant experts to provide their input during a dedicated part of the assessment scope consolidation meeting.
2.The JCA Subgroup shall finalise the assessment scope at the latest 10 days after the Committee for Medicinal Products for Human Use adopts its list of questions.The JCA Subgroup shall finalise the assessment scope within 75 days from the day on which the European Medicines Agency validates the application for a marketing authorisation or a variation to the terms of an existing marketing authorisation, 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; or
(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.
3.The HTA secretariat shall share the assessment scope finalised by the JCA Subgroup with the health technology developer in the Commission’s first request referred to in Article 10(1) of Regulation (EU) 2021/2282.
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