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.
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.
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.
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?
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.
