CASafetyReporting object

Responsible for AE reporting to CA

Sponsor

Sponsor must declare reportable events to

National CA
CA(s) of EU&EFTA Member States concerned
Relevant Co-Authority (acting as EC)

SUSAR being life-thereatening or leading to death must be reported

Immediately
Within a max of 7d upon first knowledge (+ 8d for additional information)

All other SUSARs

Within a max of 15d upon first knowledge

Provision of Annual safety report mandatory

Yes

Annual safety report shall be provided by sponsor to

National CA
Relevant EC(s)

Guidance on AE reporting procedure

Detailed information is available on OGYÉI website in section: AR reporting arising from clinical trials.

Applicable national legal framework/ Reference

Section 21 & 22 Decree No 35/2005

Additional Information

• Sponsors of commercial studies shall immediately report any SUSAR from clinical trials via the EudraVigilance system to EMA (OGYÉI in case of non-commercial studies).

• Safety Notification Letters should be sent to NIP/ OGYÉI immediately but at latest 24 hours, if the new events affect the conduct of the trial or the safety of the subjects considerably.

• Sponsors should report only those SUSARs to NIPN/OGYÉI where the primary source country is Hungary.
The sponsor shall notify all investigators participating in the clinical trial on any SUSAR.

• NB! Recent changes regarding AE reporting:
Development Safety Update Report (DSUR) report is mandatory to be provided to CA and competent EC on CD.
SUSAR Line Listing must be sent only to investigators according to the guideline of European Commission ("Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use” (2011/C 172/01 section 7.10.).

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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