4.The health technology developer shall submit the missing information, data, analyses and other evidence indicated in the Commission’s second request referred to in Article 10(5) of Regulation (EU) 2021/2282 within 15 days from the date of notification of the Commission’s second request to the health technology developer. However, that deadline shall be 10 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.
The deadlines referred to in the first subparagraph shall be 7 days for cases where only minor information is missing.