(6)In order to allow sufficient time for a high quality joint clinical assessment, that clinical assessment should start at the same time as the centralised procedure provided for under Regulation (EC) No 726/2004 of the European Parliament and of the Councilnote, that is to say upon the confirmation by the European Medicines Agency of a submission of a valid application for marketing authorisation in accordance with Regulation (EC) No 726/2004 or for a variation to the terms of an existing marketing authorisation in accordance with Commission Regulation (EC) No 1234/2008note. Therefore, it is appropriate to require the health technology developer to submit information necessary for the development of the assessment scope provided for in Article 8(6) of Regulation (EU) 2021/2282 (‘the assessment scope’) to the Commission acting as secretariat of the Coordination Group (‘the HTA secretariat’) at the same time as the health technology developer submits an application for marketing authorisation, or for a variation to the terms of an existing marketing authorisation, to the European Medicines Agency.
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