Australia Therapeutic Goods Act 1989 — Import Requirements

Australia lacked stringent import controls for therapeutic goods, risking public health.

Key Obligations

TGA import licence; ARTG registration or listing; GMP compliance; batch release testing

Penalty Ranges

Refusal of entry; fines up to AUD 222,000; criminal prosecution

Mandatory Deadline: Ongoing — licence required before import

Affected HS Codes: 3001, 3002, 3003, 3004, 3005, 3006, 9018, 9019, 9020, 9021, 9022

Issuing Authority: Therapeutic Goods Administration (TGA)