As of 31 December 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) have published new guidance on the qualified person responsible for pharmacovigilance (QPPV) and the pharmacovigilance system master files (PSMF) for existing marketing authorisation holders (MAH) in the United Kingdom (UK) in light of Brexit.
Regardless of whether the UK marketing authorisation is specific to Northern Ireland, specific to Great Britain, or covers the whole of the UK, the MAH must have a QPPV who permanently and continuously resides and operates in either the European Union (EU) or the UK. This QPPV must be responsible for the establishment and maintenance of the pharmacovigilance system.
Crucially, there is no temporary exemption to this requirement to have an EU or UK based QPPV. Additionally, in cases where the QPPV is not based in the UK, a national contact person for pharmacovigilance is required. However, in this scenario there will be a temporary exemption of 12 months from 01 January 2021 in which to appoint a national contact person for pharmacovigilance in the UK.
Once the national contact person for pharmacovigilance has been appointed, their details should be notified to the MHRA via the MHRA Submissions Portal.
For all marketing authorisations, regardless of their specificity, the PSMF must be electronically accessible from the same point in the UK at which reports of suspected adverse reactions are accessible. However, for marketing authorisations that either cover the whole of the UK or are specific to Northern Ireland, the PSMF must be located at either the site where the QPPV works or the site in the EU where the main pharmacovigilance activities are conducted.
Whilst the legal requirements concerning the format and content of the PSMF are outlined in different documents depending on the coverage of the marketing authorisation (Chapter 1 of CIR for whole UK and NI specific, Part 1 of Schedule 12A of HMR for Great Britain), they are identical. A single PSMF can be used for all UK authorised products and all that do so must be registered with the MHRA using a unique UK PSMF number.
MAHs are encouraged not to request the UK PSMF number until an application is made for a new UK marketing authorisation or when notifying the MHRA of a change in the details of the QPPV for UK authorised products from the baseline information held by the MHRA.
Specific information on how to appropriately notify the MHRA of the relevant details, including submission timeframes can be found here, along with information related to UK national licences (both authorised via mutual recognition or decentralised procedures), licences authorised via the EU centralised procedures and the process of applying for UK marketing authorisations.