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Set-Up of Pharmacovigilance System Master File (PSMF)

PSMF is a legal requirement for medical products that are authorized by the European Union. It consists of a detailed description relating to the entire pharmacovigilance system for the organization. It also documents the performance and compliance of the requirements that are described by the Good Pharmacovigilance practices. The content and structure relating to the PSMF are defined in the GVP Module II. It reflects the collection, assessment, handling, storage, and reporting of EU-authorized medicine products.

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  • A Pharmacovigilance System Master File (PSMF) summarizes your pharmacovigilance (PV) system and is a critical document for any Marketing Authorization Holder.

  • To comply with EU PV legislation requirements, all MAHs and MAH applicants in the EU must develop and maintain a PSMF for their PV system.

  • Beyond the EU, more and more requirements for other local/regional PSMFs arise (e.g., UK, France, Eurasian Union, CIS, Australia).

  • 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.

  • We follow the GVP Module II’s recommendations for the modular-based PSMF.

  • Experts at IGRS provides their pharmacovigilance expertise to understand the complexity of the PSMF and follow the regulatory guidelines on Good Pharmacovigilance Practice (GVP) that are specific to each PV system.

  • We provide assistance to our clients with the review or support in preparing a PSMF in regard to product application.

  • In case our client already has PSMF in place, we will provide them with all the support needed including updates and reviews.

  • We work with established documentation systems to create and maintain a PSMF that comprehensively and accurately describes the PV system of your organization in line with the legislative format.

  • A comprehensive PSMF is highly significant as it is a document that is shared with regulatory inspectors and provides insights into your organization’s PV system.

  • Our PSMF system shall comply with EU, UK, Australia, CIS regulations

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