As of 22 November 2017 new obligations in respect of signal management and reporting of suspected adverse reactions will apply to marketing authorisation holders.
The main points are:
– MAHs will need to ensure that all reportable ICSRs are submitted to EudraVigilance only.
– Non-serious cases will also need to be submitted to the EudraVigilance system within 90-days of receipt.
Besides, next november a new Eudravigilance system will be launched: http://bit.ly/2gf7i1C
Our Pharmacovigilance expert team of Asphalion will be pleased to help you in the adaptation to the new EMA requirements for the Data entry.
Contact us if you need any assistance at email@example.com