Public Health Emergency Policy

This Policy describes the principles upon which the Medicines Control Agency operates in the event of a Public Health emergency. The Policy defines responsibility of the competent authorities; risk assessment procedures; public health emergency. Risks in public health emergency include: import of products by unlicensed importers or uncontrolled import; use of unregistered medicines; lack of essential medicines; inappropriate storage and handling of products; uncertainty in causality assessment of adverse events of medicines; increased occurrence of serious adverse events in clinical trials; inadequate supply of raw and packaging materials. The Policy also concerns: adopted processes during a public health emergency; risk benefit considerations; emergency preparedness.