CASafetyReporting object

Responsible for AE reporting to CA

Legal representative domiciled in the EU/EEA

Reportable AEs

SAE (Serious Adverse Event)
SUSAR (Suspected Unexpected Serious Adverse Reaction)

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

As soon as possible
Within a max of 7d upon first knowledge

All other SUSARs

As soon as possible
Within a max of 15d upon first knowledge

National standard reporting form available

No, European standard SUSAR reporting form CIOMS-I recommended

Standard Reporting Form

CIOMS form available for download on the BASG website
NB: Only to be used if electronic reporting to Eudravigilance is not possible for technical reasons!

Reporting format - Options

Data carrier (USB key)
Paper hardcopy

Preferred format

Other: Electronic reporting in E2B-Format to Pharmacovigilance Database of the European Medicines Agency (EudraVigilance-Clinical Trial Module)

Online Safety Reporting Portal

Prerequisite for electronic reporting is the submission of the following form: F I437 SUSAR Ansuchen: Ansuchen um Befreiung von der Meldungsverpflichtung über schwerwiegende Nebenwirkungen gemäß § 41e AMG an das Bundesamt für Sicherheit im Gesundheitswesen (BASG) (de)/ Request for exemption from the notification obligation of SAEs according to Art 41e AMG to BASG) (en)
No further reporting to BASG, as described in Art 41e, will then be required.

Provision of Annual safety report mandatory


Annual safety report shall be provided by sponsor to

National CA
Not applicable

Guidance on AE reporting procedure available


Guidance on AE reporting procedure

L I206 Leitfaden KP Einreichung (de)
L I209 Guidance CT submission (en)

National legal framework in place


Applicable national legal framework/ Reference

Art 41d + Art 41e AMG

Additional Information

Dual-reporting of SUSARs must be avoided (EudraVigilance-Clinical Trial Module and BASG); in case of electronic reporting in E2B-Format, no further reporting obligations to CA according to Art 41e apply (e.g Annual safety report). If electronic reporting to Eudravigilance is impossible, then SUSARs reports should be sent in paper (together with supporting documentation on CD, if necessary).