Malaysia

Implement operational changes to assess and process consumer reports on side effects, ensuring additional resources are allocated for evaluations.

Sellers and distributors are mandated to cease the sale and distribution of the affected products immediately and comply with penalties for non-compliance, which may include fines up to RM50,000 or imprisonment.

Sellers must stop the sale and distribution of the canceled products immediately and monitor for compliance with NPRA regulations to avoid legal penalties.

Entities affected by this notification must review their plasma product lot processes and ensure compliance with NPRA regulations. Affected stakeholders should adjust workflows to address non-compliance issues.

Implement an immediate review of affected vaccine lots and ensure all relevant stakeholders are informed of the compliance issues for Signal Management processes.

Organizations must increase scrutiny and evaluation of vaccine safety profiles for lots identified in the notification of non-compliance.