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Article 13Commission’s confirmation of the dossier for a joint clinical assessment#
Within 15 working days from the date on which the health technology developer submitted the dossier, and as appropriate in consultation with the assessor and co-assessor, the Commission shall confirm whether, based on the information available at the time, the dossier for a joint clinical assessment of the medicinal product meets the requirements laid down in Article 9(2), (3) and (4) of Regulation (EU) 2021/2282. However, that deadline shall be 10 working 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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