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.

 

Back to the index of the Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol Version 6, 08 Jul 2020, MHRA, Medicines & Healthcare products Regulatory Agency

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