Pharmacovigilance System, incl. Master File (PSMF)

We help marketing authorisation holders

  • establish and manage their own Pharmacovigilance System, including the required Standard Operating Procedures (SOP) 
  • maintain the pharmacovigilance system master file (PSMF) 
  • convert the previous Detailed Description of the Pharmacovigilance System (DDPS)

We also share our own pharmacovigilance system and PSMF so our clients don't have to built their own.


Marketing authorisation holders are required to establish or have access to a Pharmacovigilance System which covers all pharmacovigilance activities, including organisational aspects, collection and processing of pharmacovigilance information, reporting to authorities, signal detection and initiating appropriate measures for risk reduction.
Pharmacovigilance processes need to be described in standard operating procedures (SOPs). Previously, the principles of the Pharmacovigilance activities had to be summarised in the detailed description of the Pharmacovigilance system (DDPS). In 2012, as part of the EU pharma package, the DDPS was succeeded by the Pharmacovigilance System Master File (PSMF), a much more detailed documentation which needs to be continuously maintained in a current state.