Pharmacovigilance System Master File (PSMF).
What is a PSMF?
A PSMF document is a critical and mandatory part of pharmacovigilance compliance in the EEA. Under the EU Directive 2010/84/EU, it should contain full details of the pharmacovigilance system in place for all Marketing Authorization applications, and holders, including a named EEA based QPPV to be compliant.
A PSMF must be kept fully up to date at all times and be available within 7 days on-request for any National Competent Authority to inspect, which is why the day to day management, continual update, and expertise with handling PSMFs, is a critical for any pharmacovigilance system.
The structure and content of a PSMF can be specific, but must follow GVP Module II guidelines and describe in detail the entire pharmacovigilance system for a product including key areas such as:
- QPPV.
- Marketing Authorization Applicant (MAA) or Holder (MAH) organization/structure.
- Pharmacovigilance Standard Operating Procedures (SOPs) and processes.
- Drug Safety Data.
- Electronic systems and Drug Safety Databases.
- Quality Management and Control systems.
- Annexes.
Why you should choose Arriello to manage your PSMF.
When you choose us to manage your PSMF, our team of experienced EU QPPVs and technical experts are responsible for its creation, maintenance, and ensuring your PV system remains fully compliant with European and International regulations and guidelines.
Local PSMF.
Many countries around the world have additional local requirements of the PSMF e.g., France dictates specific requirements for a global PV system; and Brazil requires the PSMF to be in Portuguese.
Our global reach and experience, combined with extensive local Regulatory Intelligence, allows us to prepare a standalone local PSMF or annexes to a global PSMF that meets all these local authority requirements while maintaining a robust and centralized PV system.
Our pharmacovigilance system transfer guide.
“Throwing good money after bad is never a good idea, yet all too often, pharma companies persevere with poor or inadequate PV information capture and reporting capabilities because the alternative – moving to a new provider – is seen as too great an upheaval and potentially too much risk.”
In this practical two-part guide, Cláudia Serafim, PV Manager & EU QPPV at Arriello, dispels the common myths around PV system transfer, sets out the benefits of making the change sooner rather than later, and provides a 13-part action plan to make the transition easy, and successful.
