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Brexit: MHRA clarifies UK PV rules for the no-deal scenario

03/04/2019

The MHRA published guidance on 12 March on Qualified Persons for Pharmacovigilance (QPPVs), Pharmacovigilance System Master Files (PSMFs) and MHRA Pharmacovigilance (PV) registration. The agency clarifies UK PV rules in the event of a no-deal Brexit, giving pharma companies 21 months to appoint a UK-based QPPV but requiring immediate access to PSMF.

If there is a no-deal Brexit, UK Marketing Authorization Holders (MAHs) will need to:

  • Notify the MHRA with a Summary of their PV system, including the UK PSMF number,
  • Submit their variations to the MHRA related to the Summary of the UK PV system (PVS) for all UK product licenses,
  • 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.

As reported before in our news Pharmacovigilance: Be prepared for "Hard Brexit", the following legal obligations will apply to MAHs in the UK, if the UK leaves the EU without a deal:

  • Operate a PVS for UK authorized products,
  • Establish an "UK QPPV” (appropriate QPPV that resides and operates in the UK and is responsible for the establishment and maintenance of the PVS for UK authorized products),
  • Maintain and make available upon request a PSMF that describes the PVS for UK authorized products (“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. However, the MAH must have permanently and continuously at its disposal a QPPV who is ordinarily resident, and operates, in the UK and is responsible for the establishment and maintenance of the PVS. As stated in MHRA´s guidance note of February 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 to take over responsibility for UK authorized 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 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 PV activities are performed or at the site where the EU/EEA QPPV operates. In addition, 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

All UK MAHs must have a Summary of PVS, including the UK PSMF number. The MAH should submit Type IAIN variations (minor variations, "Do and tell") related to the Summary of PVS to the MHRA and these submissions should cover all UK product licenses under a unique PVS. The variations are required to be submitted via the MHRA Submissions portal (see guidance on making submission to the MHRA in a no deal scenario). In the event that the UK leaves the EU without a deal, a large volume of regulatory submissions is expected. Therefore, the agency advised that updates to the Summary of PVS should be submitted as single variations and in collections of no more than twenty-five product licenses.

More information can be found in MHRA´s Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) if the UK leaves the EU without a deal.