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    Reporting requirements of suspected unexpected serious adverse reactions (SUSARs) applicable to Marketing Authorisation Holders

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    In accordance with the European Union legislation (article 17 of Directive 2001/20/EC) the sponsor of clinical trials authorised in the European Economic Area shall ensure that all relevant information about reports of SUSARs is recorded and reported to the competent authorities in all concerned member states. Cases of SUSARs associated with clinical trials authorised in the European Economic Area should be transmitted electronically as from May 2005. All sponsors are responsible for implementing standards that ensure electronic communication with regulatory authorities in full compliance with the ICH E2B (R2) standards and European Union (EU) guidelines.

    Reporting requirements of SUSARs

    All SUSARs (occurring in a study centre in Estonia and outside Estonia) should be sent directly to the European Medicines Agency via EudraVigilance database (through Gateway or Webtrader).

    SUSARs that are fatal or life threatening should be reported within 7 days following the receipt of the information and followed-up within an additional period of 8 days. Other SUSARs (not fatal and not life-threatening) should be reported within 15 days.

    Further information about clinical trials can be obtained from:

    Phone: + 372 737 4140
    E-mail: clinical.trials@ravimiamet.ee