EMEA & Pharmacovigilance

EMEA recently addressed a Communication to all Marketing authorisation holders (MAHs) in the EEA concerning the Electronic Transmission of Individual Case Safety Report (ICSRs) in the EEA.
On its website EMEA has launched new information to provide with the necessary background and to guide the MAHs for  achieving the implementation of the electronic transmission of ICSRs rapidly.
To start the electronic transmission process with the EMEA you are requested to
1. Complete the EudraVigilance current status questionnaire
2. Contact the EMEA Electronic Transmission Co-ordinator
3. Send Letter of Intent and Implementation Plan