Failure to timely report suspected cases of side effects to the EudraVigilance database by the Paul Ehrlich Institute in the years 2022 to 2025

Summary

Original text of the question(s):<br /> <br /> In the years 2022 to 2025, were suspected cases of side effects not reported to the EudraVigilance database by the Paul Ehrlich Institute within the prescribed period of 15 or 90 days, and if there were such cases, how many were there (https://x.com/BBarucker/status/1963905748590637506?ref_src=twsrc%5Egoogle%7Ctwcamp%5Eserp%7Ctwgr%5Etweet; please report separately for each year and further break it down into suspected cases that are included in the SafeVac 2.0 study and other suspected cases; please do this further according to suspected cases of serious side effects or suspected cases of non-serious side effects), and what are the (at least possible) consequences and legal consequences in the event of failure to report on time (please specify, in particular - but not exclusively - with regard to Section 97 paragraph 2b of the Medicines Act)?

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Timeline

1. 19 September 2025

   Schriftliche Frage/Schriftliche Antwort

   Failure to timely report suspected cases of side effects to the EudraVigilance database by the Paul Ehrlich Institute in the years 2022 to 2025

   Source: BT

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