The new EudraVigilance system will become operational on 22 November 2017. In order to implement this new system, the current EudraVigilance system is unavailable as of today (8 November 2017), 1.00 a.m. (Brussels time) until 22 November 2017, 10.00 a.m. (Brussels time), when the new system goes alive. So, we just entered the downtime period. During this downtime period, alternative measures apply for reporting adverse drug reactions (ADRs).
Impact for Belgium and the Netherlands
- During the downtime period, it is not possible for marketing authorisation holders and sponsors to submit ICSR’s to EudraVigilance.
- The Belgian agency (FAMHP) will stop sending (serious) ICSRs to the marketing authorisation holders as of 8 November 2017.
- ICSRs that require submission during the downtime period (these are ICSRs of which the term of 15 days after receipt expires within the downtime period) should be submitted to the new EudraVigilance system within 2 working days from the moment the EudraVigilance system is again operational.
- Concerning ICSR reporting, there will be no change in languages: Dutch, French and English are acceptable to report ICSRs.
- Articles from Literature do not need to be resent locally.
- During the downtime period in Belgium, Emerging Safety issues should be sent to adr@fagg.be. These are reports that may affect the product’s benefit-risk balance. In the Netherlands, there reports have to be sent to the Medicines Evaluation Board (MEB).
More information can be found on the following links:
- https://www.fagg-afmps.be/nl/news/aftellen_naar_de_lancering_van_het_nieuwe_eudravigilance_systeem_op_22_november_2017
- https://english.cbg-meb.nl/latest/news/2017/10/04/eudravigilance-not-available-for-10-days-from-8-november-2017
- http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/09/WC500235774.pdf