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Eudravigilance for Human Medicines

Updated Information for Marketing Authorisation Holders and Sponsors of Clinical Trials concerning E2B implementation status in Estonia

The State Agency of Medicines (SAM) of Estonia is in production with EudraVigilance PostAuthorisation and Clinical Trial Modules from 12. July 2010

26 July 2010

MANDATORY ELECTRONIC ICSR REPORTING TO EUDRAVIGILANCE POST-AUTHORISATION MODULE (HUMAN)

In accordance with Community legislation

- reports of adverse drug reactions involving authorized medicinal products for human use should be transmitted electronically as from November 2005 (article 24 of Regulation No726/2004 and article 106 of Directive 2001/83/EC as amended and Volume 9 of the “Rules Governing Medicinal Products in the EU: Pharmacovigilance for Medicinal products for human use”)

- reporting of SUSARs should be transmitted electronically as from May 2004 (Directive 2001/20/EC)

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.

EUDRAVIGILANCE MEMBER STATE VERSION
SAM is in production with EudraVigilance PostAuthorisation Module and Clinical trial Module from 12. July 2010.

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 the primary source, the report should be transmitted to the SAM no later than 15 days following the receipt of the information. Reports can be sent to SAM either

- via Eudragivilance (receiver should be only SAM) or

- on CIOMS form by post/fax or electronically to pharmacovig@ravimiamet.ee or using electronic form (www.ravimiamet.ee – Teatis ravimi kõrvaltoimest). SAM will send acknowledgements for received reports.

SAM will retransmit these reports to the EudraVigilance database.

2. If a serious adverse reaction report is received by SAM from the primary source, the report will be transmitted electronically to the EudraVigilance database indicating the Eurpean Medicines Agency (EMA) and the Marketing Authorization Holder as receiver no later than 15 days following the receipt of the information. In case Marketing Authorisation Holder is not Eudravigilance User, SAM will send the report to Marketing Authorization Holder by post. Additionally SAM always notifies local representative of Marketing Authorisation Holder.

For reactions occurred in the territory of a third country:
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 EMA. The SAM has access to those reports in the EudraVigilance database.

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.

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.
Please inform SAM about beginning of test phase by email ITsupport@ravimiamet.ee.

FOR FURTHER INFORMATION
The contact person regarding PostAuthorisation module in the test and production environment is Maia Uusküla, Bureau of Pharmacovigilance,
e-mail: pharmacovig@ravimiamet.ee, tel: +372 7 374 140

The contact person regarding Clinical Trials is Ülle Toomiste, Bureau of Clinical Assessment and Drug information,
e-mail: clinical.trials@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