5.

The Member State concerned shall assess the application and shall submit to the sponsor, through the EU portal, Part II of the assessment report, including its conclusion, and the decision as to whether the substantial modification is authorised, whether it is authorised subject to conditions, or whether authorisation is refused. Notification shall be done by way of a single decision within 38 days from the validation date. An authorisation of a substantial modification subject to conditions is restricted to conditions which by their nature cannot be fulfilled at the time of that authorisation.

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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.