On 22nd February 2018 the grace period for MAHs to become familiar with the major updates to EudraVigilance will end. From this date, a pilot period of one year will begin for the MAHs of the active substances included in this list to perform monitoring / signal detection within the EudraVigilance system. There is also a requirement for MAHs to inform the EMA and NCAs of validated signals detected when monitoring the database.
MAHs which do not have active substances in the above list are able to integrate signal detection activities within EudraVigilance. However, at the time of writing, there is no obligation to perform these activities or inform the EMA or NCAs of any signals detected when monitoring the database.
Please note: All MAHs must still perform their current in-house signal detection.
Following the end of this transitional period, the implementation phase will begin, however this is yet to be announced by the EMA.
More information can be found on the EMA website.
EUDRAC is provides a complete PV service for its clients and also provides support for clients’ existing PV systems, including signal detection. We also keep clients up-to-date on the rapidly changing PV environment through our Global PV intelligence service.
For more information on pharmacovigilance services, please contact us here.