Medicines and Healthcare products Regulatory Agency (MHRA)

Verify inventory of affected RelayPro Thoracic Stent-Graft System lots (model 28-N4-XX-XXX-XXS) and implement actions per the FSN document.

Check for affected batches of Mirtazapine 30mg Tablets as described in EL(26)A/28 and implement any necessary quarantining or recall steps.

Review adverse event reports for potential links to counterfeit weight loss medicines; check product supply chain for unlicensed sources.

Organizations must update their adverse event reporting processes to align with the clarified classification of borderline products effective immediately.

Implement mandatory quality checks and oversight for all AI-generated inspection responses to meet MHRA expectations for accuracy.

Innovators must now utilize the Innovation Accelerator for access to regulatory expertise and guidance on pharmacovigilance and risk management strategies.