CASafetyReporting object

Responsible for AE reporting to CA


Sponsor must declare reportable events to

National CA
CA(s) of EU&EFTA Member States concerned
Investigators shall also be notified

Reportable AEs

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 (+ 8d for additional information)

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
Other (see info in 'Standard Reporting Form')

Standard Reporting Form

(Non-commercial) sponsors, not being registered with the EudraVigilance network, must submit the report to Fimea in writing (fax or email is not accepted), in form of a free form letter or by using the CIOMS-I form or equivalent.
The minimum content of the report is itemised in Section 10 of Regulation 2/2012

Reporting format - Options

Online portal
Via Eudralink (EMA)
Depends on trial sponsor (commerical vs. non-commercial)

Online Safety Reporting Portal

EMA- EudraVigilance: Registration with EMA’s EudraVigilance network is mandatory for commercial sponsors and recommended for non-commercial sponsors (Guidance on registration).
Registered sponsors must submit electronic notifications to EudraVigilance. SUSARs occurring in Finland must be reported both to the Fimea database (receiver identifier FINAM) and EMA, SUSARs occurring abroad only to the EMA.

Commercial sponsors registered with the EudraVigilance network who are not yet submitting their reports electronically to the Fimea should contact the Clinical Trial Unit (Kliinisten lääketutkimusten yksikkö) to commence testing and usage.

Provision of Annual safety report mandatory


Annual safety report shall be provided by sponsor to

National CA

Guidance on AE reporting procedure

(1) Fimea Website in section: Supervison > Clinical Drug Trials > Electronic Reporting of Adverse Reactions.
(2) Further guidance has been issued by the European Commission: 'Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use'

Applicable national legal framework/ Reference

Section 10 of Regulation 2/2012
Section 10 f of Act No. 488/1999

Investigator shall report SAE to


Reporting timeline


Sponsor is obliged to notify all investigators of SAE/ SADE occurrence