EudraVigilance not available for 10 days starting 8 November 2017
The new EudraVigilance system for the reporting and analysis of suspected adverse reactions (ADRs) to medicinal products, will become operational on 22 November 2017. To allow the change-over to the new system, the current system will be unavailable from 8-21 November 2017. During this downtime period, alternative arrangements apply to marketing authorisation holders in respect of reporting of ADRs.
EudraVigilance will become unavailable on 8 November 2017, 1.00 a.m. (Netherlands time) and will be operational again on 22 November 2017, 10.00 a.m. (Netherlands time). This is the downtime period. During this downtime period, key components of EudraVigilance will not or will only be partially available. Therefore, alternative arrangements will apply to marketing authorisation holders for reporting ADRs. These procedures may differ from one Member State to another. Healthcare providers and patients can report adverse events in the usual manner; marketing authorisation holders and the Netherlands Pharmacovigilance Centre Lareb will take care of the processing.
Submitting Dutch reports during the downtime period
For submission of Dutch reports to EudraVigilance during the downtime period, the following will apply to marketing authorisation holders:
- During the downtime period it is not possible to submit reports of suspected ADRs.
- No alternative arrangements for submission will apply (e.g. submission via CIOMS form, CD-rom, fax or e-mail). However, the Medicines Evaluation Board (MEB) must still be informed when new insights become known regarding the product's benefit-risk balance.
- Submissions to EudraVigilance will be possible from 22 November 2017 10:00 a.m. (Netherlands time).
- Reports requiring submission during the downtime period should still be submitted to EudraVigilance. Compliance monitoring will take into account the downtime period when reports are submitted to EudraVigilance within 2 working days from the moment the EudraVigilance system is operational again.
- During the downtime period reports from patients and health care providers must be received as usual. These can be submitted to EudraVigilance from 22 November 2017.
Receiving Lareb reports
Lareb reports will be sent to marketing authorisation holders for the last time on 7 November 2017. As of 22 November 2017, Lareb reports will be available via EudraVigilance. To prepare for access to EudraVigilance, marketing authorisation holders must ensure that their ‘EudraVigilance User Registration’ is updated in order to have the proper login credentials. Furthermore, it is essential that data in the Art 57 database is complete and up to date.
More information and training
The Eudravigilance training material on the EMA website helps users to understand the new legal requirements, the new EudraVigilance functionalities and the new ICH E2B(R3) format. The EMA also provides various training sessions.
With the go-live of the new EudraVigilance system, a new signal management process by marketing authorisation holders will also become applicable. As a transitional arrangement, a pilot period of 1 year has been agreed. Starting 22 February 2018, only marketing authorisation holders whose active substances are included in the list of medicinal products under additional monitoring will be asked to monitor EudraVigilance and inform the national competent authorities of validated signals. More information will be published on the EMA website once the revised GVP Module IX on Signal Management becomes available.
New obligations with respect to EudraVigilance
From 22 November 2017 onwards new obligations in respect of reporting of suspected adverse drug reactions (ADRs) will apply to both marketing authorisation holders and national competent authorities. The main changes are:
- All reports of suspected adverse drug reactions requiring submission according to Regulation (EC) No 726/2004 and/or Directive 2001/83/EC should be sent to EudraVigilance directly. This obligation was already in place in The Netherlands, but will now apply in all EU Member States.
- Reports from marketing authorisation holders will be automatically re-routed to the Member State where the reaction occurred.
- Non-serious ADR reports from the European Economic area should be submitted to EudraVigilance within 90 days.
- The Dutch spontaneous reporting system is operated by Lareb. Marketing authorisation holders will no longer receive ADR reports directly from Lareb, but will be provided access to these reports via EudraVigilance. Marketing authorisation holders will have standard access to both serious and non-serious reports, including Lareb cases.
- The revised Guideline on good pharmacovigilance practices (GVP) Module VI - Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2) should be adhered to.
- The new ICH E2B(R3) format can be used for the exchange of reports of suspected ADRs.