EudraVigilance data monitoring obligations - Pilot period

From 22 November 2017 (go-live of the new EudraVigilance system), Marketing Authorisation Holders (MAH) will have extended access to the EudraVigilance database. This will allow MAHs to continuously monitor EudraVigilance data and communicate validated signals to the Agency and National Competent Authorities (NCA). These obligations are as outlined in Commission Implementing Regulation (EU) No 520/2012.

Pilot period to commence in February 2018

The European Medicines Agency and the European Commission have agreed on a phased implementation of the requirements for MAHs to monitor the EudraVigilance database.

On 22 February 2018, an initial one-year pilot period will commence during which MAHs will only be required to monitor data for the list of medicinal products under additional monitoring (black triangle).

For other active substances, the MAHs will still have access to the EudraVigilance database and will be able to use this as an additional data source for signal detection activities; however, they will not be required to continuously monitor the database for these active substances. For further information, please see the EMA Signal Management webpage.

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