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Escalations - MHRA GPVP Non-Compliance

Escalation to GPvP Compliance Management Team (CMT)

The GPvP CMT is a non-statutory group constituted to coordinate and advise the GPvP inspectorate on compliance management issues following an inspection or detection from other intelligence sources; recommendations for referrals to IAG2 for action (see below); recommendations for enforcement action.

Cases considered by the GPvP CMT include:

  • all critical inspection findings from MHRA GPvP inspections
  • findings from MHRA GPvP inspections that require referral to the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) due to concerns about, or the impact of non-compliance on, the safety of a product authorised in respect of Northern Ireland
  • organisations that have not had critical findings but where there are major findings that are at high risk of developing into critical issues (for example due to the management culture or a history of poor CAPA management)
  • critical (or comparatively graded) findings arising from non-MHRA inspections, to assess any risk to UK public health and patient safety, compliance with national requirements and the need for specific UK remediation
  • referrals of known or suspected non-compliance with pharmacovigilance obligations from internal or external sources

For MHRA GPvP inspections that have not initially resulted in a referral to the GPvP CMT, the lead inspector may refer the case to the CMT if the responses to the inspection report are considered inadequate despite requests for clarification.

Escalation to Inspection Action Group (IAG2)

There are two Inspection Action Groups (IAG) at MHRAIAG2 covers clinical trials of investigational medicinal products and the pharmacovigilance activities of MAHs and advises the directors of the Inspections, Enforcement and Standards (IE&S) and Vigilance and Risk Management of Medicines (VRMM) divisions, where appropriate.

Where recommended by CMT, cases will be referred to IAG2 for action or for information. IAG2 meets regularly to deal with ongoing business and to consider new referrals. Criteria to be met for making referrals to the IAG2 in relation to pharmacovigilance inspections include, but are not limited to:

  • conditions that are likely to cause or lead to a significant risk to public health
  • an inspection identifies one or more unresolved critical deficiencies

Early re-inspection has been the most common recommendation made by IAG2 to date. In most cases adequate progress has been observed on re-inspection; in some cases, a further re-inspection has been required and a minority of cases have been referred back to IAG2 for consideration of other actions, which may include meetings with MAH senior representatives to discuss the issues and consequences of continued non-compliance.

The daily rate inspection fee includes preparation for, reporting and close-out of the inspection. Inspections with critical findings or other significant non-compliance requiring referral to the GPvP CMT and/or IAG2 may require the inspector(s) to spend additional time beyond that covered by the daily rate overseeing the adequacy of the company’s CAPA and the company’s return to compliance. For such inspections, an office-based inspection fee may be charged for this additional time spent by the inspector(s) on such activities (for example, reviewing CAPA plans, impact assessments and periodic CAPA status updates; and corresponding with the company in writing or by teleconference).

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