To the attention of interested persons
Information for marketing authorization holders (MAHs) regarding alternative arrangements for electronic submission of ICSRs to NAMMD, Romania, during the cutover period 07-22 November 2017
The Romanian Agency (HQ ORG-ID NMA) will stop receiving ICSRs from MAHs as of 7 (00:00) November 2017.
The Romanian Agency (HQ ORG-ID NMA) will stop sending ICSRs to MAHs as of 7 (00:00) November 2017.
From 7 (00:00) to 21 (24:00) November 2017, MAHs have to report individual cases originating from the Romania in CIOMS I format to the following email address: email@example.com
Any ICSRs from 7 November should be submitted by MAHs to EVPM after 22 November along with the other cutover legacy ICSRs (according to GVP Module VI, rev. 2 coming into effect on 22 November 2017).
Detailed information is available in the document EudraVigilance go-live plan (for Romania please see option 2B, Table 4, page 33).
For further information please see EMA press release.