Contents
- 1. The health technology developer shall submit the dossier f…
- 2. The deadline to submit the dossier referred to in paragrap…
- 3. In justified cases, with the consent of the assessor and c…
- 4. The health technology developer shall submit the missing i…
- 5. Where the assessor, with the assistance of the co-assessor…
- 6. Where the Coordination Group decides to re-initiate a join…
- 7. If during the joint clinical assessment, the health techno…
- 8. Once the HTA secretariat receives the dossier and further…
2.The deadline to submit the dossier referred to in paragraph 1 shall be 100 days from the date of the notification of the first request to the health technology developer. However, that deadline shall be 60 days 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.
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