--- title: Is your Pharmacovigilance Systems Master File already approved and in place? description: Pharmacovigilance System Master File (PSMF), describes the details of the pharmacovigilance system, focusing on the Quality Management System (QMS). image: https://blog.pqegroup.com/hubfs/Vet%20Questions_2-1.jpg --- [![Logo PQE Group - azzurro - 2024](https://blog.pqegroup.com/hs-fs/hubfs/Logo%20PQE%20Group%20-%20azzurro%20-%202024.png?width=2000&height=721&name=Logo%20PQE%20Group%20-%20azzurro%20-%202024.png "Logo PQE Group - azzurro - 2024")](https://www2.pqegroup.com) - [Home](https://www2.pqegroup.com/) - [Industry](https://www2.pqegroup.com/industry/) - [Pharma & API](https://www2.pqegroup.com/pharma-api/) - [Medical Device](https://www2.pqegroup.com/medical-device/) - [Biotech](https://www2.pqegroup.com/biotech/) - [Startup](https://www2.pqegroup.com/startup/) - [Veterinary](https://www2.pqegroup.com/veterinary/) - [Services](https://www2.pqegroup.com/services/) - [Data Integrity](https://www2.pqegroup.com/data-integrity/) - [Digital Governance](https://www2.pqegroup.com/digital-governance/) - [Engineering](https://www2.pqegroup.com/engineering/) - [Commissioning, Qualification and Validation (CQV)](https://www2.pqegroup.com/commissioning-qualification-validation/) - [Quality Compliance](https://www2.pqegroup.com/quality-compliance/) - [Laboratory Excellence](https://www2.pqegroup.com/laboratory-excellence/) - [Regulatory Affairs](https://www2.pqegroup.com/regulatory-affairs/) - [Audits](https://www2.pqegroup.com/audits/) - [Training](https://www2.pqegroup.com/training/) - [Clinical Research](https://www2.pqegroup.com/clinical-research-services/) - [Pharmacovigilance](https://www2.pqegroup.com/pharmacovigilance/) - About - [About Us](https://www2.pqegroup.com/about/) - [ESG](https://www2.pqegroup.com/about/csr/) - [Women in STEM](https://www2.pqegroup.com/about/women-in-stem/) - Resources - [News & Press](https://www2.pqegroup.com/news/) - [Webinars](https://www2.pqegroup.com/webinars/) - [Blog](https://blog.pqegroup.com/) - [Careers](https://www2.pqegroup.com/careers/) - [Contact Us](https://www2.pqegroup.com/contact-us/) ![](https://blog.pqegroup.com/hubfs/blank-user.png) Leonardo Giraudo Pharmacovigilance Compliance Expert @PQE Group # **Is your Pharmacovigilance Systems Master File already approved and in place?** [Pharmacovigilance](https://blog.pqegroup.com/tag/pharmacovigilance) ## ABSTRACT The [Veterinary Pharmacovigilance System](https://blog.pqegroup.com/ra-phv/is-your-pharmacovigilance-systems-master-file-already-approved-and-in-place#PSMF) established by EU Regulation (EU) 2019/6 mandates Marketing Authorization Holders (MAHs) to establish and maintain a pharmacovigilance system for the management of adverse events related to their veterinary medicinal products. A crucial component of this system is the [Pharmacovigilance System Master File (PSMF)](https://blog.pqegroup.com/ra-phv/is-your-pharmacovigilance-systems-master-file-already-approved-and-in-place#Master), which describes the details of the pharmacovigilance system. The PSMF focuses on the [Quality Management System (QMS)](https://blog.pqegroup.com/ra-phv/is-your-pharmacovigilance-systems-master-file-already-approved-and-in-place#QMS) supporting pharmacovigilance processes and activities, including standard operating procedures, subcontracted tasks, adverse event and signal management, risk management, communication, training, documentation management, performance monitoring, change control, auditing, and corrective actions. An effective and comprehensive PSMF ensures compliance with regulations and facilitates successful audits by the MAH and supervision by the Qualified Person for Pharmacovigilance (QPPV). Ensuring a compliant PSMF minimizes potential issues during Competent Authority Inspections.   ## Regulation (EU) 2019/6 established the Veterinary Pharmacovigilance System  In January 2022, the EU Reg. 2019/6 **Marketing Authorization Holders (MAH)** was adopted in order to fulfil **veterinary pharmacovigilance responsibilities.** Based on this regulation, manufacturers must establish and maintain a system, known as a **pharmacovigilance system**, for the management of **suspected adverse events** concerning their **authorized veterinary medicinal products,** in order to guarantee the **safety** of their products for **animal health**.   ## The pharmacovigilance system master files (PSMF)  The details of the pharmacovigilance system are described by the MAH in one or more **pharmacovigilance system master files (PSMF)**, the format and content of which are described in the Commission Implementing Regulation (EU) 2021/1281 and in the related **Veterinary Good Vigilance Practice** Module. The **Qualified Person for Pharmacovigilance (QPPV)** is responsible for the elaboration and maintenance **of the PSMF.**  ## The pharmacovigilance system master files (PSMF) main aspect  In addition to the details on the MAH and the QPPV and their back-ups, the primary aspect of the PSMF gives importance to the description of the **Quality Management System (QMS)** that supports the pharmacovigilance process and activities. The author of the document must furnish a detailed description of the **Standard Operating Procedures (SOPs)** that support all pharmacovigilance activities and must detail the tasks that have been subcontracted to third parties.   ## Pharmacovigilance system master files (PSMF) and quality management system (QMS)  The document must describe the QMS that has been developed in order to comply with the Veterinary Good Vigilance Practice modules; in particular, it must describe the systems for adverse event management, signal management, risk management, communication, training, documentation management, performance monitoring, change control, auditing and management of corrective actions.   ## Expectation from a pharmacovigilance system master file (PSMF)  In conclusion, an effective and well written PSMF contributes to the management of a pharmacovigilance system and, in particular, contributes to the appropriate planning of an audit by the MAH and the **supervision** from the QPPV.   Do you think that your PSMF is compliant with regulations and that you will not have problems during next Competent Authority Inspections?    ###### ​​Bibliography  ​*COMMISSION IMPLEMENTING REGULATION (EU) 2021/1281 of 2 August 2021 laying down rules for the application of Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacovigilance practice and on the format, content and summ. (2021). Bruxelles: Official Journal of the European Union.* *​EMA/595115/2021 Guideline on veterinary good pharmacovigilance practices (VGVP) Module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files. (2021). Amsterdam: EMA. * *​REGULATION (EU) 2019/6 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC. (2019). Bruxelles: Official Journal of the European Union.*   [« #1](https://blog.pqegroup.com/ra-phv/are-your-products-correctly-classified-eu-2019-6)                              [#3 »](https://blog.pqegroup.com/ra-phv/is-your-quality-management-system-effective-in-supporting-the-pharmacovigilance-processes-and-activities-are-you-ready-for-your-next-inspection)  ![Vet Questions_2](https://blog.pqegroup.com/hubfs/Vet%20Questions_2.jpg) ## More on our services for the veterinary industry? PQE Group's expertise is available for the quality of your animal health products. Our experts at PQE Group will help you with Veterinary Medicinal Pharmacovigilance, Regulatory Affairs, and compliance assurance with the regulatory standards. Check out our [Veterinary services](https://www2.pqegroup.com/veterinary/)and contact us to request a meeting with our experts. [Connect with us](https://www2.pqegroup.com/contact-us/) #### More on this topic [Pharmacovigilance ![AI in Pharmacovigilance: Human Oversight as a Cornerstone](https://blog.pqegroup.com/hubfs/AI%20in%20Pharmacovigilance_Blog-1.webp)](https://blog.pqegroup.com/pharmacovigilance/ai-in-pharmacovigilance-human-oversight-as-a-cornerstone) 21 Apr 2026 ## [AI in Pharmacovigilance: Human Oversight as a Cornerstone AI is transforming pharmacovigilance. 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