EMA announced on 22nd May 2017 that the enhanced EudraVigilance system will be launched on 22nd November 2017, and mandatory electronic reporting through EudraVigilance will be applicable from this date.
Q: Is NoMA expecting to implement any particular national requirements in addition to the requirements in the GVP module VI?
Q: Will NoMA be following EMA's timelines and be ready for centralised reporting and import/export of cases in ICH E2B-R3 format by 22nd November 2017?
Q: Will case narratives in reports originating from NoMA still will be in Norwegian?
A: Case narratives are written in English, and this practice will be continued. The Norwegian text currently found in the case narrative field (due to size issues) is our feedback to the reporter. Feedback will still be provided to reporters in Norwegian, but whether this will be included in the ICSRs is not yet clarified.
Q: Is NoMA planning to distribute a line listing for the first six months of 2017, and, if so, when will the line listing be distributed?
A: The original plan was to launch the new system in March 2017, but the project has been delayed. Due to the delay we will distribute a line listing covering the first six months of 2017, probably in early September – and in addition we will distribute a line listing for the period July 1st – until start date of centralised reporting (November 22nd 2017).
EudraVigilance change management.
Information from EMA.