F. MHRA Actions, Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol Version 6, 08 Jul 2020, MHRA

Upon receipt of a serious breach notification, the MHRA will review and assess the notification, and a variety of actions may be taken, depending on the nature of the breach and its potential impact. In general:

1. The GCP Inspectorate checks the serious breach mailbox.

2. Receipt of the notification will be sent and a GCP Inspector will be assigned to review.

3. The Inspector is responsible for reviewing the serious breach.

4. The inspector will decide if:

  • the referral only requires to be logged with no further action (the case may be examined during future MHRA inspections).
  • further information/investigation/CAPA is required. If insufficient information is provided in the initial notification to assess the impact of the breach, follow-up information will be requested.
  • if any other bodies are required to be notified (for example, other competent authorities/EMA, Licensing Division, Clinical Trials Unit (CTU), HRA, Research Ethics Committees, other GxP areas, etc.).
  • further actions are required (for example, a referral to the MHRA Inspection Action Group if the issue is critical or trigger an inspection to investigate further).
  • referral to CTU for consideration of suspension or termination of a clinical trial authorisation.
  • referral to the MHRA Enforcement Unit for consideration of enforcement action, for example, infringement notices, criminal investigation.
  • referral to professional bodies, for example, the General Medical Council.
     

5. Once any/all required actions have been satisfactorily completed, the inspector will close the referral.

 

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