Australia TGA Therapeutic Goods Act 1989

Australia lacked stringent controls on therapeutic goods safety and importation.

Key Obligations

["ARTG registration mandatory for therapeutic goods", "Import permit for restricted therapeutic goods", "GMP compliance for manufacturing facility"]

Penalty Ranges

Fines up to AUD 222,000; imprisonment up to 5 years

Affected HS Codes: ["3001", "3002", "3003", "3004", "3005", "3006", "9018", "9019", "9020", "9021"]

Issuing Authority: Therapeutic Goods Administration (TGA)