6.

During the period referred to in the second subparagraph of paragraph 5, the Member State concerned may request, with justified reasons, additional information from the sponsor regarding the substantial modification as far as its territory is concerned. For the purpose of obtaining and reviewing this additional information from the sponsor, the Member State concerned may extend the period referred to in the second subparagraph of paragraph 5 by a maximum of 31 days. The sponsor shall submit the requested additional information within the period set by the Member State concerned which shall not exceed 12 days from receipt of the request. Upon receipt of the additional information, the Member State concerned shall complete its assessment within a maximum of 19 days. Where the sponsor does not provide additional information within the period set by the Member State concerned in accordance with the third subparagraph, the application shall be deemed to have lapsed in that Member State. The request for additional information and the additional information shall be submitted through the EU portal.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.