The Pharmacovigilance System Master File, or PSMF, describes the pharmacovigilance system of a marketing authorisation holder. It demonstrates how safety information for their medicinal products is collected, assessed, and processed in accordance with regulations. The QPPV is the qualified person residing in the European Union who assumes responsibility for this system. <\/p>\n
The PSMF is not a one-time submitted study or authorisation document. It documents a living pharmacovigilance system for one or more medicinal products of a marketing authorisation holder and must reflect the actual current state. This documentation enables authorities, audits, inspections, and the QPPV to comprehensibly review the system’s structure, processes, responsibilities, and functionality. <\/p>\n
Implementing Regulation (EU) No 520\/2012 requires, among other things, information on the QPPV, organisational structure, locations of pharmacovigilance activities, data sources, computerised systems, processes, and performance indicators. It also covers the management of outsourced activities. The PSMF must reflect the worldwide availability of safety information for EU-authorised medicinal products, although the legal responsibility remains with the marketing authorisation holder. <\/p>\n
The Qualified Person responsible for Pharmacovigilance (QPPV) oversees compliance with pharmacovigilance obligations and has sufficient authority to promote, maintain, and improve the system’s compliance. They must be continuously and uninterruptedly available and reside and operate in the European Union. Their contact details and duties are part of the regulatory pharmacovigilance information. <\/p>\n
The QPPV is not merely a contact person for adverse event reports. They require an overview of safety data, reporting processes, signals, risk management, post-authorisation studies, and changes to product information. The actual execution may be distributed or outsourced, but the QPPV must maintain oversight and be able to escalate relevant issues to the marketing authorisation holder. <\/p>\n
Maintaining the PSMF requires a documented system for updates. Changes in organisation, service providers, databases, or essential processes must be reviewed to determine if they affect the description or functionality of pharmacovigilance. A PSMF that is only supplemented during inspection preparation does not fulfil its purpose. Authorities expect consistency between content, references, and actual working practices. <\/p>\n
The System Master File also depicts the interface between global organisation and European responsibility. Safety information may originate internationally, but for EU-authorised medicinal products, it must be available within a controlled system. Outsourcing does not relieve the marketing authorisation holder of oversight. Therefore, contracts alone are insufficient; responsibilities, information flows, quality controls, and escalation mechanisms must function practically within the system and be comprehensibly described. <\/p>\n
For inspections, not only the presence of documents is crucial. The authority may want to verify whether the PSMF accurately describes the real system, whether the QPPV has access to decision-relevant information, and whether the marketing authorisation holder effectively manages deviations. A clear, current, and referencable System Master File therefore reduces the risk of practical procedures and formal descriptions diverging. <\/p>\n
The PSMF is thus not an end in itself. It makes visible whether the pharmacovigilance system can actually fulfil its tasks reliably, in a controlled manner, and across all involved functions. <\/p>\n
This also applies to reorganisation or new service contracts.<\/p>\n
The Risk Management Plan describes safety concerns for a specific medicinal product, as well as pharmacovigilance and risk minimisation measures. The PSMF, in contrast, describes the organisation-wide system by which such tasks are performed. A Risk Management Plan is therefore not a substitute for the System Master File, and the System Master File is not a product-related risk action plan. <\/p>\n
Particularly important is the distinction from the existing related entry, qualified-person. The Qualified Person for GMP, usually referred to as QP, certifies batches before marketing and is responsible for batch-related GMP release. The QPPV, on the other hand, is responsible for the pharmacovigilance system after authorisation. QP and QPPV are different functions with different legal bases, qualifications, and areas of responsibility. <\/p>\n
Clinical studies provide safety information that can transition into pharmacovigilance after authorisation. Therefore, responsibilities, data flows, vendor oversight, and safety databases must be designed so that relevant information reaches the marketing authorisation holder’s system completely and comprehensibly. Inspections examine not only individual reports but also the effectiveness of the entire process chain and its documentation. <\/p>\n
Full-service CROs like Mediconomics support with safety data flows, SOP interfaces, case processing, pharmacovigilance audits, and the documentation of outsourced tasks. Specific contributions range from safety writing and data reconciliation to the preparation of PSMF-relevant descriptions and cooperation with the QPPV. <\/p>\n
Must the PSMF be maintained separately for each medicinal product?<\/strong><\/p>\n A PSMF can describe the pharmacovigilance system for one or more medicinal products of a marketing authorisation holder, provided it adequately and currently reflects the system.<\/p>\n Is the QPPV the same person as the GMP QP?<\/strong><\/p>\n No. The QPPV is responsible for pharmacovigilance; the QP for GMP is responsible for batch certification and release. <\/p>\n Does the Risk Management Plan replace the System Master File?<\/strong><\/p>\n No. The Risk Management Plan is product-specific, while the PSMF documents the structure and functioning of the pharmacovigilance system. <\/p>\n The Pharmacovigilance System Master File, or PSMF, describes the pharmacovigilance system of a marketing authorisation holder. It demonstrates how safety information for their medicinal products is collected, assessed, and processed in accordance with regulations. The QPPV is the qualified person residing in the European Union who assumes responsibility for this system. Content and Purpose of […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[20],"class_list":["post-7794","glossary","type-glossary","status-publish","hentry","glossary-cat-regulatory-affairs-zulassung"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7794","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":0,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/7794\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=7794"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=7794"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory References<\/h2>\n
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