The MHRA published guidance on 12 March on QPPVs, PSMFs and MHRA PV registration in the event of no deal, aimed at providing practical information and instructions to UK MAHs 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.
Further detail is set out below, but if there is a no-deal Brexit, UK MAHs will need to:
- notify the MHRA with a summary of their PV system, including the UK PSMF number
- submit their IAIN variations to the MHRA related to the summary of the UK PV system for all UK product licences
- ensure the UK PSMF is available with immediate effect at the stated location in the UK
- appoint a UK QPPV by the end of 2020
If the UK leaves the EU on 29 March 2019 without a deal, the following legal obligations will apply to marketing authorisation holders (MAH) in the UK:
- To operate a pharmacovigilance system for UK authorised products.
- To have an appropriate 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.
Role and responsibilities of the UK QPPV
The role and responsibilities of the UK QPPV are equivalent to that of the EU/EEA QPPV. 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:
“(a) 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.”
As stated in section 1.9 of the further guidance from January 2019, a temporary exemption is in place to allow companies until the end of 2020 to appoint a UK QPPV that resides and operates in the UK. This temporary exemption regarding the location of the UK QPPV 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.
UK PSMF location
The UK PSMF shall be located at the single 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 differs from the EU concept where the EU PSMF shall be located either at the site where the main pharmacovigilance activities are performed or at the site where the EU/EEA QPPV operates.
The UK PSMF shall be permanently and immediately available for inspection at the stated location in the UK.
Notification of UK QPPV and PSMF details to the MHRA by existing holders of UK marketing authorisations
All UK MAs must include a summary of the MAH’s pharmacovigilance system, including the UK PSMF number. The MAH should submit Type IAIN variations related to the summary of pharmacovigilance system (“SPS”) to the MHRA and these submissions should cover all UK product licences (“PL”) under a unique pharmacovigilance system.
All applications to update the SPS are required to be submitted as a Type IAIN – C.I.8.a variation via the MHRA Submissions portal (guidance on making submission to the MHRA in a no deal scenario can be found online). In the event that the UK leaves the EU without a deal, a large volume of regulatory submissions is expected, and in order to avoid undue delays MHRA advised that updates to the SPS should be submitted as single changes and in collections of no more than 25 PLs.