Pharmacovigilance System Master File

As of July 2015, every marketing authorization holders (MAH) is required to have a Pharmacovigilance System Master File (PSMF) which is a paper or electronic document describing the pharmacovigilance system of the MAH.

The information contained in the PSMF should be an accurate and up-to-date reflection of the pharmacovigilance system under the QPPV’s responsibility. It should be located either at the site in the EU where the main pharmacovigilance activities of the marketing authorisation holder are performed or at the site in the EU where the QPPV operates.

MAHs are required to submit information concerning all medicinal products for which they hold a marketing authorisation in the EU, to the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD). This also applies to the pharmacovigilance details such as the name and contact details of the (EU)QPPV and the location of the PSMF.