MHRA Compliance Monitor (CM) programme – Inspection readiness

From April 2022 the MHRA will be introducing a Compliance Monitor programme to improve the supervision of appropriate companies who are at Inspection Action Group (IAG) stage to assist with inspection readiness.

IAG (inspection Action Group)

A company will be referred to the IAG criteria if during MHRA inspection one or more critical deficiencies are identified.  Referrals may also be made as a consequence of;

  • Licence variation
  • Refusal to accept inspection / lack of communication by company to organise an inspection
  • Product recall
  • Issue raised by another EU member state
  • As an outcome of an enforcement activity

The IAG can propose removal of the RP/QP, suspension of the licence, increase inspection visits or request a meeting with the licence holder.

Medical Information service

The Programme

The programme will utilise consultants acting as Compliance Monitors (CM’s) who will be paid for by the company and will work with them towards completing actions identified within a Compliance Protocol (CP) that has been agreed with the MHRA, company and CM.

Successful completion of the CP will result in an MHRA re-inspection, which will determine if the company can be removed from the Inspection Action Group referral process.

The programme is a pilot scheme and further details on the CM role and application process will be provided in due course.

The programme will be of benefit to;

  1. The Patient by minimising potential product shortages in supply of safe medicines
  2. The MHRA as it will allow focused resource for the statutory risk based inspection programme.
  3. The company who are at IAG stage as it will reduce direct MHRA inspection/communication during the remediation process

Our Quality team have experience preparing for and hosting MHRA inspections and can ensure that both your site and staff are inspection ready. Post-inspection, we can help address any deficiencies raised and support you with MHRA responses, until the licence is granted. Get in touch at consultancy@jensongroup.com.