No variation for change of QPPV and/or PSMF location

As of 1 February 2016, a change in the “Qualified Person responsible for PharmacoVigilance” (QPPV) or the location of the “Pharmacovigilance System Master File” (PSMF) no longer needs to be submitted to the MEB via a variation.

Marketing authorisation holders are obliged to submit and maintain the information as described in the EMA Guidance documents, in the article 57 database (also known as the “eXtended EudraVigilance Medicinal Product Dictionary” (XEVMPD)).

For the time being, it is still necessary to submit a summary of the PSMF in the event of a change in the marketing authorisation holder of a medicinal product.