Pharmacovigilance System Master File (PSMF)

For all UK national MAs, including those that cover the whole of the UK or are specific to Northern Ireland or to Great Britain, the MAH must maintain, and make available upon request of the MHRA, a PSMF that describes the pharmacovigilance system for UK authorised products (‘the UK PSMF’).

PSMF accessibility in the UK

All UK PSMFs must be accessible electronically at the same point in the UK from which the reports of suspected adverse reactions referred to in regulation 187 of the Human Medicine Regulations (HMR) are accessible.

The PSMF needs to be permanently and immediately available for inspection at the stated location in the UK.

PSMF format, content and representation of pharmacovigilance systems

For MAs that cover the whole of the UK or are specific to Northern Ireland, the legal requirements concerning the format and content of the PSMF that are outlined in Chapter I of Commission Implementing Regulation (CIR) (EU) 520/2021 will remain unchanged.

For MAs that are specific to Great Britain, legal requirements concerning the format and content of the PSMF are outlined in Part 1 of Schedule 12A of HMR, which mirrors Chapter I of CIR.

As the legal requirements concerning PSMF format and content are identical for MAs that cover the whole of the UK and Northern Ireland, and those that are specific to Great Britain, a single UK PSMF can be used for all UK authorised products. This is assuming that the pharmacovigilance system applied to all products is the same.

Statutory guidance concerning the PSMF for UK authorised products is described in GVP Module II. This guidance is supplemented by the MHRA guidance ‘Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders’.

The UK PSMF must describe the global pharmacovigilance system and reflect the global availability of safety information for UK authorised products.

As per GVP Module II, there are different approaches to establishing a pharmacovigilance system. For example:

The UK PSMF should be an accurate representation of the pharmacovigilance system that has been established and a unique PSMF number should be assigned by the MHRA.

All PSMFs that cover UK authorised products should be registered with the MHRA via the Submissions Portal. Once a UK PSMF number is assigned to a pharmacovigilance system, it should remain unchanged, irrespective of how the system may change and evolve over time.