Last July EMA started a pilot phase to provide MAH’s a new service of medical literature searches (mandatory task for authorized products, according to pharmacovigilance legislation).
From the 1st September, this system entered into full operation, meaning that for 400 active substances (300 chemical + 100 herbal) EMA is doing all the work of literature searches in international databases (EMBASE and EBSCO). This way guaranteeing that different MAH’s marketing the same active substances, will get the same results.
The results are published in EudraVigilance, in each MAH’s profile (see below), in a new separate module and can be downloaded and even imported into MAH’s PcV tools (for example, PcVmanager from Extedo).
If you need more information, check this link: http://bit.ly/1K80ABn
Even though this work is now being performed by EMA, it is the responsibility of each MAH to guarantee that these results are correct.
Therefore, Asphalion highly recommends all MAHs to continue performing their global literature searches, besides, of course, the local (national) searches that are not covered by EMA.