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UK MHRA: Guidance on Qualified Person responsible for QPPV & PSMF

Last Thursday (11 May 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated "Guidance on the qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)".

The QPPV is appointed by the marketing authorization holder (MAH) and must be a medical doctor or pharmacist with specific training and experience in pharmacovigilance. The QPPV is responsible for overseeing the pharmacovigilance system for a given medicinal product or product, ensuring the development and maintenance of a pharmacovigilance system that complies with regulatory requirements.


The marketing authorization holder (MAH) of all UK MAs, whether they cover the whole of the UK or Northern Ireland, or Great Britain, is required to have a QPPV at hand who is permanently and continuously available at his or her disposal.


Pharmacovigilance System Master File (PSMF) is a comprehensive document that describes the pharmacovigilance system of a marketing authorization holder (MAH)and is a centralized document that contains information about the company's pharmacovigilance system and is maintained by the MAH.


It is important that the UK PSMF describes the global pharmacovigilance system as well as the availability of safety information for UK-approved products throughout the world. It is important that the UK PSMF represents the pharmacovigilance system accurately, and the MHRA must assign a unique PSMF number to every pharmacovigilance system covering UK-approved products.


The material to accompany an application for a UK marketing authorisation includes a summary of the applicant’s pharmacovigilance system (SPS). This guidance replaces the previous requirement to submit a Type IA(IN) variation and an accompanying eCTD sequence to make these changes and only an update notification is required, there is no requirement to submit an eCTD sequence. This guidance applies from 11 May 2023.


To understand in-depth and to know more about the updates click this LINK






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