The Announcement of the EMA Management Board earlier in May 2017 confirmed the full functionality of the EudraVigilance database. Hence, the transitional period in pharmacovigilance reporting in the EEA is about to expire. The simplified electronic reporting of suspected adverse reactions related to medicines by national competent authorities and marketing authorisation holders to EudraVigilance becomes mandatory on 22 November 20171.
On 13 October 2017 EMA published its Revision 1 of EudraVigilance Go-Live Plan concerning the launch of the improved version of EudraVigilance and the steps to be followed by national competent authorities, marketing authorisation holders (MAHs) and sponsors of clinical trials in the EEA.
In accordance with that, the Romanian National Agency for Medicines and Medical Devices published an announcement regarding the functionality of Eudravigilance database. 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 and will stop sending ICSRs to WHO UMC 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 e-mail: 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.
Regarding the Bulgarian Drug Agency (BDA), EVPM: the BDA (HQ ORG-ID BDA) will stop receiving ICSRs from MAHs as of 8 (00:00) November 2017. The BDA (HQ ORG-ID BDA) will stop sending ICSRs to MAHs as of 8 (00:00) November 2017 and will stop sending ICSRs to WHO UMC as of 8 (00:00) November 2017. EVCTM: the BDA (HQ ORG-ID BDA – Affiliate CTBDAP) will stop receiving ICSRs from sponsors from 8 (00:00) to 21 (24:00) November 2017. The announcement by the BDA is available here.
The transition period will also affect the use of the electronic application form (eAF). The eAF will remain available but will be affected as far as the substance selection for an initial marketing authorisation application is linked to the XEVMPD (Article 57 database)2. It will not be possible to update substance data in the XEVMPD for the creation of the eAF dataset during this downtime period. The EMA strongly recommends that MAHs with a marketing authorisation application date coinciding with the scheduled downtime (8 to 21 November 2017), carefully review and update relevant data beforehand.
1 Legal background: Section 1 “Recording and reporting of suspected adverse reactions” of Chapter 3 “Recording, reporting and assessment of pharmacovigilance data” under Title IX “Pharmacovigilance” of Directive 2001/83/EC and Articles 24(4), 28(1), 28a(1)(c) and 28c(1) of Chapter 3 “Pharmacovigilance” under Title II “Authorisation and supervision of medicinal products for human use” of Regulation (EC) No 726/2004.
2 See EMA’s Technical Note on the planned EudraVigilance downtime from 8 to 21 November 2017.