PSMF Management.
Maintenance, QPPV provision & full PV system setup.

What is PSMF Management?

A Pharmacovigilance System Master File (PSMF) is an essential and obligatory component of pharmacovigilance compliance within the European Economic Area (EEA) in accordance with Directive 2001/83/EC.

PSMFs provide a detailed description of the pharmacovigilance system used by a Marketing Authorisation Holder (MAH) with its authorised human and veterinary medicinal products and is maintained independently from the Marketing Authorisation (MA) itself. It must be permanently available for inspection and provided within 7 days to National Competent Authorities on request.

Within the EEA, the PSMF can be kept at one of two designated locations: either where the primary pharmacovigilance activities of the MAH are carried out or where the Qualified Person for Pharmacovigilance (QPPV) operates. It’s essential to note that QPPVs are required to be based and active within the EEA.

Click for more information from the European Medicines Agency (EMA) on PSMFs.

When initiating a Marketing Authorization Application (MAA), MAHs are obligated to provide a detailed description of the pharmacovigilance system that will be in operation and fully functional at the time the application is granted, ensuring that any future plans are distinctly outlined and separated. During the evaluation process of their MAA, MA applicants may be requested to provide a copy of the PSMF for review and assessment.

Whilst there is no fixed structure for a PSMF it must follow the guidance within Good Pharmacovigilance Practices (GVP), Module II, and typically cover 6 areas:

  • Qualified person responsible for pharmacovigilance
  • Organizational structure
  • Computer system
  • PV processes
  • Quality system activities
  • Delegated activities

Click for more information from the EMA on GVP Module II.

Why use Aegisana’s PSMF Management services?

Full compliance.

Aegisana’s Pharmacovigilance team have extensive experience managing client PSMFs and all the day-to-day updates and maintenance required.

We can design and implement your entire Global PV System and how it interacts with Regulatory and Quality functions, provide qualified QPPVs and all LPPV & Local Safety Personnel including any Local PSMF requirements, across multiple countries and authorities.

Reliable and competent.

We want you to have complete peace of mind that your system is fully compliant and inspection ready, through our trademark efficient and competent delivery.

However complex your requirements, we are ready to provide the perfect turnkey pharmacovigilance system to meet them.