Information for Marketing Authorisation Holders and Sponsors of Clinical Trials concerning E2B implementation status in Estonia
MANDATORY ELECTRONIC ICSR REPORTING TO EUDRAVIGILANCE POST-AUTHORISATION MODULE
In accordance with Community legislation (article 24 of Regulation No726/2004 and article 106 of Directive 2001/83/EC as amended) reports of adverse drug reactions involving authorized medicinal products for human use should be transmitted electronically as from November 2005.
All Marketing Authorisation Holders in the European Economic Area are responsible for implementing standards that ensure electronic communication with regulatory authorities in full compliance with the E2B (M) standards agreed at the level of ICH and Community guidelines.
WEB TRADER
The State Agency of Medicines (SAM) of Estonia uses currently the EudraVigilance WEB Trader application for electronic transmission of Individual Case Safety Reports (ICSRs). The SAM is in production with EudraVigilance PostAuthorisation Module.
EUDRAVIGILANCE MEMBER STATE VERSION
SAM is in the final phase to switch from WEB Trader to Eudravigilance Member State Version.
TEST PHASE OF EUDRAVIGILANCE MEMBER STATE VERSION
- The SAM Organisation ID in the test environment is SAMT
- The SAM Organisation ID in the production environment is SAM
In the test phase, the SAM will accept ICSRs from EU and from nonEU countries. We will accept about 10 reports from each Marketing Authorization Holder. It is up to the Marketing Authorization Holder to decide which cases to send in the test phase (i.e. follow up, parent-child, nullification, etc…). In the test phase please send reports to the test environment. Please notify the SAM before initiating testing procedures.
The State Agency of Medicines of Estonia can start testing phase from now on. Please inform SAM about beginning of test phase by email
(Maia.Uuskula@ravimiamet.ee and ITsupport@ravimiamet.ee).
ELECTRONIC REPORTING OF ADVERSE REACTIONS TO ESTONIA
For reactions occurred in Estonia:
1. If a serious adverse reaction report is received by a Marketing Authorization Holder from a healthcare professional, the report should be transmitted to the SAM no later than 15 days following the receipt of the information. The SAM will send acknowledgements for received reports. The SAM will retransmit these reports to the EudraVigilance database.
At the moment (until Eudravigilance Member State Version will be in production phase) the reports should be sent to SAM either on CIOMS form by post or electronically to pharmacovig@ravimiamet.ee or using electronic form (www.ravimiamet.ee – Teatis ravimi kõrvaltoimest).
2. If a serious adverse reaction report is received by SAM from a healthcare professional, the report will be transmitted electronically to the EudraVigilance database indicating the EMEA and the Marketing Authorization Holder (if the product name is noted in the report) as receiver no later than 15 days following the receipt of the information. SAM will send the report to Marketing Authorization Holder also by post.
For reactions occurred outside Estonia:
1. All suspected serious unexpected adverse reactions and any suspected transmission via a medicinal product of any infectious agent occurring in the territory of a third country should be transmitted electronically to the EudraVigilance database by the Marketing Authorization Holder.
The Marketing Authorization Holder should indicate as a receiver only the EMEA. The SAM has access to those reports in the EudraVigilance database.
The obligation to report ADRs from third countries (Directive 2004/27/EC article 104(4)) will be regarded fulfilled if the report is sent directly to the EudraVigilance database (EMEA) by MAH.
2. In case Estonia is Reference Member State (in Mutual Recognition Procedure or Decentralized Procedure) all suspected serious unexpected adverse reactions and any suspected transmission via a medicinal product of any infectious agent occurring in the territory of a third country should be additionally transmitted to SAM:
- At the moment (until Eudravigilance Member State Version will be in production phase) the reports should be sent to SAM either on CIOMS form by post or electronically to pharmacovig@ravimiamet.ee.
- When Eudravigilance Member State Version is in production Marketing Authorization Holder should indicate as a receiver both EMEA and Estonia.
MANDATORY ELECTRONIC SUSARS REPORTING TO EUDRAVIGILANCE CLINICAL TRIALS (CTS) MODULE
Requirements for reporting SUSARs to the investigational medicinal product:
1. SUSARs occurring in the study centres in Estonia should be sent electronically by the sponsor both
- directly to the EudraVigilance Clinical Trials module and
- to the SAM e-mail clinical.trials@ravimiamet.ee
2. National SUSARs that are fatal or life threatening should be reported within 7 calendar days and followup within an additional period of 8 days.
3. Other national SUSARs (not fatal and not lifethreatening) should be reported within 15 days.
4. SUSARs from other Member States and third countries concerned should be sent electronically to the EudraVigilance database CT module. These reports should not be sent directly to SAM; the requirement will be regarded fulfilled if these reports are sent to the EudraVigilance CT module (the SAM has access to it).
FOR FURTHER INFORMATION
The contact person regarding PostAuthorisation module in the test and production environment is Maia Uusküla, Bureau of Pharmacovigilance,
email: Maia.Uuskula@ravimiamet.ee, tel: +372 7 374 140
The contact person regarding Clinical Trials is Ülle Toomiste, Bureau of Alinical Assessment and Drug information,
e-mail: Ulle.Toomiste@ravimiamet.ee, tel: +372 7 374 140
The contact person regarding technical issues is Olav Remmelgas,
e-mail: ITsupport@ravimiamet.ee, tel: +372 7 374 140
The contact person regarding veterinary products is Hilkka Voll,
e-mail: Hilkka.Voll@ravimiamet.ee
Results