II.B. Structures and processes

The PSMF is a legal requirement in the EU. This guidance concerns the requirements for the PSMF and is applicable for any medicinal product authorised in the EU, irrespective of the marketing authorisation procedure. The required content and management of the PSMF applies irrespective of the organisational structure of a marketing authorisation holder, including any subcontracting or delegation of activities, or their location. Irrespective of the location of other activities, the qualified person for pharmacovigilance (QPPV’s) residence, the location at which he/she carries out his/her tasks and the PSMF location must be within the EU. Following European Economic Area (EEA) agreements, the QPPV may also reside and operate in Norway, Iceland or Liechtenstein.

The content of the PSMF should reflect global availability of safety information for medicinal products authorised in the EU, presenting information on the pharmacovigilance system applied at global, regional and local levels.