To the attention of interested persons
Information for sponsors of clinical trials regarding the electronic submission of SUSARs to NAMMD, Romania, during the cutover period 07-22 November 2017
The Romanian Agency (HQ ORG-ID NMA) will stop receiving SUSARs from sponsors from 8 (00:00) to 21 (24:00) November 2017.
SUSARs reports in CIOMS I format should be transmitted by email to the following address: farmacovigilenta@anm.ro
Any SUSARs from 7 November should be submitted by MAHs to EVCTM and NAMMD after 22 November along with the other cutover legacy SUSARs.
Detailed information is available in the document EudraVigilance go-live plan (for Romania please see option 2A, Table 7, page 51).
For further information please see EMA press release.