2.4. Follow-up reports of SUSARs

If the initial report of a SUSAR referred to in point (a) of Article 42(2) (fatal or life-threatening) is incomplete, for example if the sponsor has not provided all the information within seven days, the sponsor shall submit a completed report based on the initial information within an additional eight days. The clock for initial reporting (day 0 = Di 0) starts as soon as the information containing the minimum reporting criteria has been received by the sponsor. If significant new information on an already reported case is received by the sponsor, the clock starts again at day zero, that is the date of receipt of the new information. This information shall be reported as a follow-up report within 15 days. If the initial report of a SUSAR referred to in Article 42(2)(c) (initially considered to be non-fatal or non-life-threatening but which turns out to be fatal or life-threatening) is incomplete, a follow-up report shall be made as soon as possible, but within a maximum of seven days of first knowledge of the reaction being fatal or life-threatening. The sponsor shall submit a completed report within an additional eight days. In cases where a SUSAR turns out to be fatal or life-threatening, whereas initially it was considered as non-fatal or not life-threatening, if the initial report has not yet been submitted, a combined report shall be created.

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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.