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Safety reports

Serious unexpected suspected adverse reaction (SUSAR) reporting

Suspected unexpected serious adverse reactions (SUSAR) are reported in accordance with Regulation (EU) 536/2014 and during transition period also in accordance with Directive 2001/20/EC, and Cabinet of Ministers Regulation No. 289 of 23 March 2010 “Regulations Regarding the Procedures for Conduct of Clinical Trials and Non-interventional Trials of Medicinal Products, Labelling of Investigational Medicinal Products and the Procedures for Assessment of Conformity of Clinical Trial of Medicinal Products with the Requirements of Good Clinical Practice”, as well as in accordance with European Commission guidelines “Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use” (“CT-3”) (2011/C 172/01).

Henceforth, clinical trial sponsors must report all suspected unexpected serious adverse reactions or SUSARs observed both in Latvia and outside of Latvia to the clinical trial module of the EudraVigilance database with the receiver identifier EVCTMPROD.

Contact information regarding SUSAR reporting:
Vita Bērziņa

Annual Safety Report (ASR)

Clinical trial sponsor must submit an updated investigational medicinal product safety report (Annual Safety Report) once a year starting from approval date and no later than within 60 days of the deadline laid down in the protocol. The report must contain updated information regarding all SUSARs observed during the year of review and possibly caused by investigational medicinal product, as well as a summary regarding safety of trial subjects during clinical trial. If clinical trial duration is less than one year, the safety report may be submitted together with the notification of completion of clinical trial.

• The sponsor may submit the updated investigational medicinal product safety report to the State Agency of Medicines in electronic format via e-mail or by submitting a CD, if the CT (clinical trial) was approved in Latvia in accordance with Directive 2001/20/EC. If CT was approved in accordance with Regulation (EU) 536/2014, the sponsor must submit DSUR in CTIS (Clinical Trial Information System).