EudraVigilance New

messages in brief | 24/05/2017

After the European database EudraVigilance now fulfills all functionalities required by Regulation (EC) No. 726/2004, these have been positively accepted by an independent audit and confirmed by the Pharmacovigilance Risk Assessment Committee (PRAC), the EMA Management Board has now given the green light for the changeover to "central reporting" as of June 22, 2017. The new version of EudraVigilance will thus go live with all additional features on November 22, 2017, after a six-month transition period.For more information, please visit:

EMA

as well as

Announcement of the EMA Management BoardConfirmation of full functionality of the EudraVigilance database

Email

Further inquiry note