Safety reporting

Report a medicine safety concern

Reports from patients, healthcare professionals, carers and businesses help identify medicine-related risks and support appropriate regulatory action.

Choose the type of concern that best describes the issue. Reports should not be used to request urgent medical assistance — in an emergency call 999.

Suspected adverse reaction

Report an unexpected or harmful effect that may be associated with a medicine or medical device.

Product-quality defect

Report contamination, damaged packaging, incorrect labelling, unusual appearance or another suspected quality problem.

Suspected falsified or substandard medicine

Report concerns about the authenticity, provenance, composition or quality of a medicine.

Medication error

Report an error involving the selection, prescribing, dispensing, administration or use of a medicine.

Clinical-trial safety event

Submit a serious adverse event, suspected unexpected serious adverse reaction or other required clinical-trial safety report.

Controlled-drug incident

Report a loss, theft, discrepancy, unauthorised activity or suspected diversion involving controlled drugs.