An outdated, incomplete, or inaccurate Pharmacovigilance System Master File is one of the most common inspection findings across Africa. Jeyflex provides expert PSMF authoring, regular review, annex maintenance, and local PSMF support, ensuring your PSMF accurately reflects your current pharmacovigilance system and is always ready for regulatory scrutiny.
PSMF Authoring, Review & Maintenance Across Africa
Would Your PSMF Pass an Inspection Today?
What is a Pharmacovigilance System Master File (PSMF)?
The Pharmacovigilance System Master File (PSMF) is a mandatory document that provides a comprehensive description of the pharmacovigilance system used by a Marketing Authorization Holder (MAH) for all their medicinal products. It is the primary document that regulatory authorities review during a pharmacovigilance inspection — acting as proof that the MAH has a functioning, compliant system in place.
The PSMF must describe the pharmacovigilance system in its entirety, including:
Jeyflex authors, reviews, and maintains PSMFs that accurately reflect your current pharmacovigilance system and withstand inspection.
Our PSMF Management Process
Every PSMF engagement follows a structured process from initial assessment through to authoring, review cycles, and ongoing maintenance aligned with GVP Module II requirements.
01
PSMF Gap Assessment
We begin with a thorough review of your existing PSMF or an assessment of what is required if no PSMF exists, against current GVP Module II requirements and the specific expectations of your target African regulatory authorities.
02
PSMF Authoring
We author a complete, GVP Module II-compliant PSMF that covers the main document and all required Annexes (A to I), accurately reflecting your current pharmacovigilance system, organizational structure, QPPV details, SOPs, and electronic systems.
03
Quality Review & Sign-Off
The completed PSMF undergoes a structured quality review to check accuracy, completeness, and alignment with current regulatory requirements before being presented for QPPV sign-off and formal approval.
04
Annex Maintenance
The PSMF Annexes (A to I) must be kept continuously updated to cover the QPPV, delegated tasks, sources of safety data, PV processes, local PV system performance, quality system details, and more. We manage this ongoing maintenance so nothing falls out of date.
05
Ongoing PSMF Updates
Whenever your pharmacovigilance system changes new products, new markets, SOP updates, QPPV changes, or new electronic systems, the PSMF must be updated within 90 days. We monitor your system for triggering changes and update the PSMF accordingly.
06
Local PSMF Support
Several African regulatory authorities require a local PSMF, a country-specific adaptation of the main PSMF reflecting local PV operations, the local safety officer, and market-specific requirements. Jeyflex prepares and maintains both the global and local PSMF across your African markets.
Understanding PSMF Annexes (A to I)
The PSMF Annexes are supplementary documents that provide crucial detailed information required by health authorities. Each annex must be maintained separately and kept up to date independently of the main PSMF document.
Jeyflex manages all nine annexes — keeping each one current, accurate, and ready for inspection at all times.
Why Choose Jeyflex for PSMF Services?
Our PSMF Services
A complete PSMF service covering initial authoring through to ongoing lifecycle management.
What Happens When Your PSMF is Out of Date?
An outdated PSMF is one of the most frequently cited inspection findings. The consequences are direct and serious:
Your PSMF must accurately reflect your current pharmacovigilance system at all times — not just at the time it was written.
Frequently Asked Questions
A Pharmacovigilance System Master File (PSMF) is a mandatory document that describes the pharmacovigilance system of a Marketing Authorization Holder (MAH) for all their medicinal products. It is required by regulatory authorities as evidence that the MAH has a functioning, compliant pharmacovigilance system in place. Under GVP Module II, all MAHs operating in markets that follow EMA guidelines are required to maintain a PSMF. An increasing number of African NRAs — including Kenya’s PPB, Uganda’s NDA, Nigeria’s NAFDAC, and South Africa’s SAHPRA — require or expect a PSMF as part of the marketing authorisation conditions.
The PSMF must be updated within 90 days of any significant change to the pharmacovigilance system — including changes to the QPPV, new products, new markets, SOP updates, new or changed electronic systems, or changes to the organisational structure. Additionally, the PSMF Annexes must be kept continuously current as the underlying data changes. Jeyflex monitors your system for triggering changes and manages updates to ensure the 90-day requirement is always met.
The main PSMF is a global document that describes the overall pharmacovigilance system for all products and all markets. A local PSMF — sometimes referred to as a country PSMF or affiliate PSMF — is a market-specific adaptation that describes the local PV arrangements, the local safety officer or LPPV, and any country-specific requirements or operations. Several African regulatory authorities require a local PSMF in addition to the global document. Jeyflex prepares and maintains both.
Yes — and this is one of the most common situations we encounter. We begin with a comprehensive gap assessment comparing your existing PSMF against your current PV operations and current GVP requirements, then produce a remediated PSMF that accurately reflects the present state of your system. We also establish an ongoing maintenance programme to ensure it never falls behind again.
Yes. This is one of Jeyflex’s core strengths — managing the PSMF and local PSMFs across multiple African markets simultaneously, under a single coordinated engagement. Rather than managing separate PSMF programmes for each country, Jeyflex provides a consolidated service with a single point of accountability for your entire PSMF portfolio.
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