With the launch of the improved EudraVigilance (EV) System, and the move to the simplified reporting of adverse reaction reports (ADRs) on 22nd November 2017, Marketing Authorisation Holders and EV users in Ireland must familiarise themselves with the HPRA’s national arrangements that will be in place during the changeover period.
As of 4th November the HPRA closed its reporting gateway and MAH’s must not submit ICSRs/SUSARs to HPRA from this time, as all submissions will be lost upon go-live date (22nd November) in the system (EudraVigilance Go-Live Plan).
To facilitate EV users, there will be a 3-day ‘cutover legacy’ period from 22nd – 24th November when all ‘backlog’ ICSRs can be submitted to EudraVigilance with Compliance timelines adjusted to reflect the downtime during this period.
Any SUSARs sent to EVCTM from 4th to 7th November should be submitted to HPRA after 22nd November along with the other cutover legacy SUSARs. Sponsors and investigators are also obliged to notify the HPRA within 3 days of any action needed to protect the health and safety of clinical trial subjects, in accordance with the HPRA Guide to clinical trial applications
New Simplified reporting of Adverse Reaction Reports
From 22nd November all serious ICSRs that occur within or outside the EU will be reportable directly to EudraVigilance and no longer to individual National Competent Authorities (NCAs)/ Marketing Authorisation Holders (MAHs).
All non-serious cases occurring in the EU will also be reportable to EudraVigilance by NCAs and MAHs. These final reporting arrangements are further described in Revision 2 of Module VI of the Good Pharmacovigilance Practice guide.
All reporting shall be in line with the final reporting arrangements as described in Directive 2001/83/EC as amended. Therefore all serious and non-serious ICSRs that occur in Ireland will be reportable directly to EudraVigilance by the MAH and not to the HPRA.
A key aspect of the new EudraVigilance system is its compatibility with the E2B(R3) format. Stakeholders may submit and receive ICSRs and SUSARs in the E2B(R3) format from 22nd November 2017 onwards, if their internal systems have been updated to meet this requirement.
For MAH EVWEB users any reports will automatically be generated in the E2B(R3) format and so it is recommended that these MAHs undergo training on EVWEB and the new ICH E2B(R3) format to gain familiarity with new functionalities and changes as there will be a new interface and improved functionalities.
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