Following the EMA Management Board announcement in May 2017
that the EudraVigilance (Human) database has achieved full functionality, EMA will launch the new and improved system with enhanced features for reporting and analysis of suspected adverse reactions related to medicines on 22 November 2017.
In order to realise the go-live, a downtime period of 10 business days is foreseen from 8 to 21 November 2017.
The planned downtime will impact the following IT systems and business processes:
1.EudraVigilance (Human) system and XEVMPD (Art.57 database)
Key components of EudraVigilance will not or will only be partially available from 8 to 21 November 2017. These are as follows:
- The EudraVigilance registration system will be unavailable. Registrations of new organisations or users and updates to existing users should be submitted in a timely manner by 15 October 2017 so they can be processed by EMA before the registration system becomes unavailable on 8 November 2017.
- EVWEB, the application for electronic reporting of individual case safety reports (ICSRs) for authorised medicinal products and suspected unexpected serious adverse reactions (SUSARs) for products subject to investigation in clinical trials in the EEA will not be available to users of competent authorities, marketing authorisation holders and sponsor of clinical trials in the EEA.
- XEVMPD (Art.57 database) will not be available for the electronic submissions of data on medicines (Article 57). This applies to new entries and updates to existing entries, which should be completed where possible, prior to the 8 November 2017. Where this is not possible, the data submission should take place as of 22 November 2017.
- Signal management by NCAs and EMA will be impacted to a small extent, as the current EVDAS will be kept operational but with the dataset not refreshed daily during the downtime.
The adrreports.eu portal (www.adrreports.eu) website for the general public and healthcare professionals will remain live.
The reporting by patients and healthcare professional to national Competent Authorities (NCAs) and to marketing authorisation holders (MAHs) in the EEA will not be impacted.
PSUR submission will not be affected. However, due to the unavailability of the XEVMPD
(Article 57 database) from 8 to 21 November 2017, the PSUR Repository
will be affected by the downtime as the product selection for the PSUR submissions is linked to XEVMPD
(Article 57) data. Due to this reason it will not be possible to update/amend product data
in the XEVMPD
(art.57 database) for the creation of the XML delivery files
during this downtime period.
The EMA strongly recommends that MAHs, with a PSUR submission date falling during the scheduled downtime, carefully review the list of products available through the PSUR Repository xml delivery file user interface
to ensure availability of the products included in the relevant procedures
. MAHs should create the xml delivery file and submit their PSUR prior to the 8 November 2017, where applicable.
Alternatively, if an earlier submission cannot be accommodated, MAHs are encouraged to review the availability of products and correctness of the entries in the XML delivery file user interface. The MAHs should contact the EMA service desk to request a late submission ID to submit initial PSURs after the due date. There is no need to request late submission ID for subsequent submissions, such as responses.
The eAF will remain available. However, due to the unavailability of the XEVMPD
(Article 57 database) from 8 to 21 November, the use of eAF will be affected as the substance selection for an initial marketing authorisation application is linked to the XEVMPD
(Article 57 data).
It will not be possible to update substance data in the XEVMPD (art.57 database) 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.
4.EudraCT database and EudraCT data warehouse
The EudraCT database and EduraCT data warehouse will remain available. However, due to the unavailability of XEVMPD
(Article 57 database) from 8 to 21 November 2017 and other EudraVigilance components as outlined under point 1, the EudraCT database and EudraCT data warehouse will be affected.
- For protocol data and the registration of substance data in the XEVMPD (Article 57 database) as part of the preparation of the clinical trial application, entries should be completed prior to the 7 November 2017. Where this is not possible the data submission should take place as of 22 November 2017.
- The EudraCT data warehouse used by NCAs and EMA will be impacted to a small extent. It will be kept operational but with the dataset not refreshed during the downtime (in particular the reports on protocol data and the SUSAR monitoring reports).