RESPONDING TO THE MHRA’S REQUIREMENT FOR A UK PHARMACOVIGILANCE SYSTEM MASTER FILE (PSMF): Strategy, planning, execution and delivery By Vasavi Kalyani Garlapalli, John Verheul, and Amisha Sandhu
The pharmacovigilance system master file (PSMF) is a detailed description of the pharmacovigilance system used by the marketing authorisation holder (MAH) for their authorised medicinal products. In fact, it was the European Medicines Agency (EMA), in July 2012, who first formalised the concept of the PSMF via the Good Vigilance Practice (GVP) Module II guideline. With the United Kingdom’s (UK) departure from the European Union (EU), the Medicines & Healthcare products Regulatory Agency (MHRA) mandated an independent UKPSMF for MAHs. This article focuses on measures taken to strategise, plan, implement and publish a new UK PSMF during the rapidly evolving regulatory situation following the withdrawal of the UK from the EU. and should represent the global availability of safety data for those products.
In 2020, Novartis initiated preparatory actions, having anticipated that the new requirements should be implemented by the end of the Brexit transition period (early 2021). Several potential UK PSMF models were considered as options to meet the evolving requirements:
(reference: II.B.4. Information to be contained in the pharmacovigilance system master file- Paragraphs 1 and 2 of Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and the licensing authority. GVP Module II – Pharmacovigilance system master file (Rev 2))
1. An integrated EU and UK PSMF 2. Pharmacovigilance Sub-System File (PSSF)
At this stage, due to the precise clarification of the scope of the UK PSMF (required to reflect only the PV system for the UK nationally authorised products*) and the representation of the global availability of safety data for those products, models 1 and 2 were excluded.
3. Standalone PSMF In terms of PSMF requirements, it was apparent early on that the MHRA would follow a similar approach to the EMA. However, the exact scope was clear only after the publication of new guidance from the MHRA on 1 Jan 2021. The scope of the UK PSMF was to describe the pharmacovigilance system for UK nationally authorised products, and was required to include the details of the UK Qualified Person for Pharmacovigilance QPPV. The annexes must be specific to UK nationally authorised products, including those in respect of Northern Ireland,
*Novartis has no Northern Ireland (NI) only licenses.
Due to the limited execution period, the strategy was to implement the stand-alone UK PSMF in two stages, which also enabled us to dovetail with the company’s ongoing EU-PSMF review cycle. This approach also provided an opportunity to assess how we could develop a UK PSMF 3
