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 authorised 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.
In the test phase, the SMCA will accept ICSRs from EU and from non-EU countries. We will accept about 10 reports from each Marketing Authorization Holder and will send acknowledgements for them. 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 SMCA before initiating testing procedures. The testing procedure is not needed for organisations that use the WebTrader application.
ELECTRONIC REPORTING OF ADVERSE REACTIONS TO LITHUANIA
For reactions occurred in Lithuania:
1. If a serious adverse reaction report is received by a Marketing Authorization Holder from a healthcare professional and non-healthcare professional, the report should be transmitted electronically to the SMCA of Lithuania (SMCAP), no later than 15 days following the receipt of the information. The SMCA will send acknowledgements for received reports. The SMCA will retransmit these reports to the EudraVigilance.
2. If a serious adverse reaction report is received by SMCA from a healthcare professional and non-healthcare professional, the report will be transmitted electronically to EudraVigilance 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.
For reactions occurred outside Lithuania:
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 EudraVigilance by the Marketing Authorization Holder. The Marketing Authorization Holder should indicate as a receiver only the EMEA. The SMCA 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.
Please note that in case of system failure that prevents MAHs from sending an electronic report, the report must be sent using an internationally recognised CIOMS I form.
It is recommended for MAHs to wait for full system function of electronic ICSR interchange with SMCA and not to submit ICSRs during this period. In case that expedited reporting timelines could be overstepped it is possible to send ADR report in an alternative way: to submit reports in xml format on CD media. Reports will be loaded to SMCA‘s database manually by SMCA‘s staff, confirmation of reports receipt will be obtained from SMCA by e-mail. Generated acknowledgement messages will be sent to MAHs electronically after restoration of full system function. Reports submitted in this manner will not be re-transmitted to SMCA electronically after full system restoration.
Please also separately inform SMCA about system failure via email email@example.com
Requirements for reporting SUSARs to the investigational medicinal product:
1. SUSARs occurring in the study centres in the Republic of Lithuania (national) should be sent electronically by the sponsor both directly to the EudraVigilance Clinical Trials moduleand to the SMCA. The SMCA will send acknowledgements for received reports.
2. National SUSARs that are fatal or life-threatening should be reported no later than within 7 calendar days and follow-up within additional 8 days.
3. Other national SUSARs (not fatal and not life-threatening) 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 SMCA; the requirement will be regarded fulfilled if these reports are sent to the EudraVigilance CT module (the SMCA has access to it).
FOR FUTHER INFORMATION
|Last Update: 2015-10-05 16:18:00|