To the attention of Market Authorisation Holders (MAH) / MAH Representatives / Sponsors
Notification on electronic transmission of adverse reactions to the EudraVigilance, April 21 to April 25, 2016
Following notification by the European Medicines Agency (EMA) on unavailability of the EudraVigilance production environment, including EVWEB, Gateway and MLM services, from 11.00 hrs. (Romania time), April 21th, to 11.00 hrs. (Romania time), April 25th 2016, Market Authorisation Holders/ Sponsors are reminded that no E2B file format adverse reaction reports (ICSRs / SUSARs) may be submitted electronically to the NAMMD during this time.
The NAMMD recommends MAH / Sponsors timely processing of cases with reporting deadlines during this time and their electronic submission in E2B format, before 11:00 hrs. (Romania time), April 21th, 2016.
In case of MAH / Sponsor failure to process and electronically submit cases with reporting deadlines during the specified time (21 to 25 April 2016), submission may be done by either fax: +40 213 163 497 (CIOMS format) or e-mail: adr@anm.ro (CIOMS format).
MAH / Sponsor should keep in mind that, as soon as the EudraVigilance system has become functional, case reports submitted by fax/e-mail during this time shall also be submitted electronically in E2B format.