The European Medicines Agency (EMA) will launch a new version of EudraVigilance on 22 November 2017. To allow for a smooth transition from the current to the new EudraVigilance system, a cutover (downtime) period of 10 business days i.e. from 8 November (00.00 a.m. UK time) to 21 November 2017 is taking place. All IT systems and business processes which will be impacted by the planned downtime are described in documents published on EMA’s website:
In connection with the transition to the improved EudraVigilance system in EU SÚKL is adopting the following measures:
- As of 7 November 2017 (00.00 CET) SÚKL will stop receiving ICSRs from MAHs as well as SUSARs from CT sponsors. With respect to possible time delay for creating and sending ACK message to submitted ADR reports we kindly ask MAHs to submit their ICSRs sufficient time prior to SÚKL cutover to allow SÚKL system to create and send acknowledgement message (recommended time for the last ICSR submission is 6 November 2017 12.00 a.m. CET). In addition, it is necessary that MAHs follow up time compliance of ICSRs that they process and submit them sufficient time prior to the planned system downtime (in SÚKL as well as in EMA).
- As of 7 November 2017 (00.00 CET) SÚKL will stop sending ICSRs to MAHs.
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From 7 November (00:00 CET) to 21 November 2017 (24:00 CET), MAHs have to report individual cases originating from the Czech Republic in CIOMS I format to the following dedicated email address (in pdf format): farmakovigilance@sukl
cz . “ADR reporting - Failure of safety message generation at receiver’s side” should be written in the e-mail subject. The receipt of the ICSR will be acknowledged by an email from the SÚKL’s side. As part of the alternative arrangements, the MAH is expected to report suspected adverse reactions in accordance with the current interim reporting provisions – it means all serious reports originated in CZ which fulfil the rules for reporting in the transition period.
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From 7 November (00:00 CET) to 21 November 2017 (24:00 CET), CT sponsors have to report SUSARs originating from the Czech Republic in CIOMS I format to the following dedicated email address (in pdf format): klinsekret@suklcz. “SUSAR reporting cutover period” should be written in the e-mail subject.
- All reports (ICSRs, SUSARs) from 7 to 21 November 2017 have to be subsequently submitted by MAHs and CT sponsors (as original report senders) to EVPM or EVCTM respectively after EV system goes live even if they had been reported to SUKL via the alternative channel (CIOMS I); SÚKL is not going to re-send these cases to EV system. This has to be done from 22 November (9.00 UK time) to 24 November 2017 as part as of the cutover legacy.
Reports submitted within 2 EMA business days of the gateway and the new EudraVigilance system made available after the downtime will have the reporting compliance calculated against the first day of new EudraVigilance system downtime i.e. 8 November 2017. - As of 22 November (9.00 UK time) 2017 NCAs and MAHs need to comply with new simplified reporting rules for ADR submissions (ICSRs) as indicated in GVP Module VI (revision 2) – reports are sent directly to EVPM – serious cases from CZ within 15 days, non-serious cases from CZ within 90 days. As of that day MAHs should not send any ICSRs directly to SUKL’s ID. SUKL is not going to receive any reports from MAHs and re-submit them to EudraVigilance database.
- As of 22 November 2017 the reporting rules remain unchanged for CT sponsors (the same setting as before SÚKL downtime) - SUSARs originating from the Czech Republic should be reported directly to EVCTM only.
- SÚKL guideline PHV-4 version 5 will no longer be in force as of 8 November 2017, a new version 6 of this Guideline will be published and enter into force on 22 November 2017.
Pharmacovigilance Dept.
16.10.2017
