The EU Pharmacovigilance System Master File (PSMF) is a legally required document created and maintained by a Marketing Authorisation Holder (MAH). Essentially, the document is a comprehensive description of the MAH’s Pharmacovigilance System.
The PSMF is used to document and support the MAH’s compliance with EU Pharmacovigilance regulations and guidance. Each PSMF should describe a single Pharmacovigilance system. A MAH may hold multiple PSMFs, and multiple MAHs may share a single PSMF.
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The requirement for MAHs to create and maintain a PSMF was first introduced in European Union (EU) legislation in 2010, with Directive 2010/84/EU amending Directive 2001/83/EC on human medicines.
The initial legislation was strengthened and expanded with the release of Commission Implementing Regulation (EU) No 520/2012 (IR) and the Good Pharmacovigilance Practice (GVP) Module II – Pharmacovigilance System Master File, in 2012.
The GVP Module II has since been revised twice. Once in 2013, and again in 2017.
While the IR contains the minimum legal requirements for the content and maintenance of the PSMF, the GVP module contains the expected best practices to be implemented by MAHs.
The PSMF can be broken into 3 sections. The cover page, the main body (core) and the annexes.
The PSMF’s main body is separated into 7 distinct modules:
Each Module covers a critical part of the MAH’s Pharmacovigilance system.
There are then 9 annexes that roughly mirror the main body modules, with the exceptions of annexes H and I:
When submitting a marketing authorisation application, part of the product dossier includes a ‘Summary of the Pharmacovigilance System’.
This summary must refer to the location where the PSMF is kept.
For an EU PSMF, the location must be within the EU/EEA and should either be at the site where the Qualified Person for Pharmacovigilance (QPPV) operates, or at the site where the main pharmacovigilance activities take place.
While the Summary of the Pharmacovigilance System must include the PSMF location, other steps must be taken to ensure the PSMF is registered with the EMA.
Each EU PSMF must have a unique code assigned by the EMA’s Eudravigilance system. The code is assigned when the PSMF is registered in the Article 57 database (xEVMPD). The PSMF code is tied to the location of the PSMF and any change to the PSMF’s location information must be updated in the xEVMPD within 30 calendar days of the change.
Information on the PSMF location information of MAHs is available to the public on the EMA’s website.
There is no set rule on how often the PSMF should be updated, however the frequency of updates should correlate to the Pharmacovigilance system it describes. A complex Pharmacovigilance system including many necessary updates on marketing authorisation, contractual arrangements, sources of safety information will require more frequent updates to the PSMF than a leaner system for e.g. one product authorised in one country.
The exception is for situations where a competent authority has requested a copy of an MAH’s PSMF. Unless otherwise specified, the MAH must provide an up-to-date copy of the PSMF within 7 calendar days of the request.
As the PSMF annexes hold the detailed information, they will generally require more maintenance than the main body of the PSMF. The QPPV may choose to perform more frequent updates to the annexes to ensure the information is kept up to date and no Pharmacovigilance system changes are missed between updates.
Regardless of the frequency of the updates, it is essential that there is a system in place to capture all changes to the PSMF within the logbook found in Annex I. The update process should undergo a quality check, with final approval and sign off provided by the QPPV.
While the responsibility for having a PSMF describing an MAH’s Pharmacovigilance sits with the MAH, it is perfectly acceptable to outsource the creation and maintenance of the PSMF to a third party. ProPharma’s QPPV Office team has extensive experience working with many different Pharmacovigilance systems and are regularly responsible for the creation and maintenance of client PSMFs. This includes not only experiences with EU PSMFs but also from many other countries worldwide, including but not limited to Australian, UK, and Saudi Arabian PSMF.
Contact us to speak to one of our experts about your PSMF requirements.