The Medicines and Healthcare products Regulatory Agency (MHRA) have updated their guidance on the qualified person responsible for pharmacovigilance (QPPV) including the pharmacovigilance system master files (PSMF) in a no-deal Brexit. In a no-deal Brexit scenario, the following legal obligations will apply to marketing authorisation holders (MAH) in the United Kingdom (UK):
- “To operate a pharmacovigilance system for UK authorised products.
- To have an appropriately qualified QPPV that resides and operates in the UK and is responsible for the establishment and maintenance of the pharmacovigilance system for UK authorised products (“the UK QPPV”).
- To maintain and make available upon request a PSMF that describes the pharmacovigilance system for UK authorised products (“the UK PSMF”). The UK PSMF must be located in, or accessible electronically from, the UK at the same site at which adverse reaction reports may be accessed.”
The guidance from the MHRA focusses on the role and responsibilities of the UK QPPV, the development and registration of the UK PSMF and the notification of the summary of pharmacovigilance system to the MHRA.
In accordance with The Human Medicines Regulations (HMR), regulation 182(2) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (“the EU Exit Regulations”)), the holder must “have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance who is ordinarily resident, and operates, in the United Kingdom and is responsible for the establishment and maintenance of the pharmacovigilance system.” The role and responsibilities of the UK QPPV are equivalent to that of the European Union (EU)/European Economic Area (EEA) QPPV.
It is important to note that there is a temporary exemption in place which means you will have 21 months after exit day to appoint a UK QPPV that resides and operates in the UK. This will “allow the EU/EEA QPPV who, immediately before exit day, resided and operated in an EEA state, to assume responsibility for UK authorised products until a QPPV who resides and operates in the UK can be established.”
The UK PSMF needs to be located at the same point in the UK from which the reports of suspected adverse reactions referred to in HMR regulation 187(4) are accessible (electronically or physically). This is different from the EU concept in which the EU PSMF is located either at the site where the main pharmacovigilance activities are performed, or at the site where the EU/EEA QPPV operates.
The requirements for the format and content of the UK PSMF are equivalent to that of the EU PSMF, however the annex content should be specific to UK authorised products. Every pharmacovigilance system covering UK authorised products should be identified by a unique number and all UK PSMFs must be registered with the MHRA.
Immediately after exit day in a no-deal Brexit scenario, a UK PSMF number request form will be available on the MHRA website. The MHRA have stated that you should not request a UK PSMF number until you plan to update the summary of pharmacovigilance system (SPS) for the UK product licences (PL) via submission of a variation application.
The guidance goes into further detail on notification of UK QPPV and PSMF details to the MHRA by existing holders of UK marketing authorisations and how to make the submission and the documentation that you will need to supply in a Type IAIN C.I.8.a variation submission (Introduction of, or changes to, a summary of pharmacovigilance system for medical products for human use).
Additional guidance provided relates to UK national licences (including those authorised via mutual recognition or decentralised procedures), licences authorised via the European Union (EU) centralised procedure and guidance for applications for UK marketing authorisations.
To read the MHRA’s guidance on QPPV including the PSMF in a no-deal Brexit, please click here.