Importing Pharmaceutical products from Hungary into Australia (2026)

No FTA exists between Australia and Hungary, so full MFN duties apply to all pharmaceutical imports; the most critical compliance obligation is confirming each product is listed or registered on the ARTG before the shipment departs Hungary, as ABF will hold unconfirmed goods at the border.

No FTA — MFN rates applyHS Chapter 30

Compliance requirements

⚠Verify ARTG registration for every therapeutic good line item before booking the shipment from Hungary.
⚠Ensure your TGA Import Licence covers the specific pharmaceutical products being imported prior to lodging the entry.
⚠For any narcotic or psychotropic lines, obtain an ODC shipment-specific permit at least 10-15 business days before departure.
⚠All therapeutic goods for human use must be listed or registered on the Australian Register of Therapeutic Goods (ARTG) before importation — ABF will hold shipments if the ARTG entry cannot be confirmed at the border
⚠The importer must hold a current TGA Manufacturing or Import Licence (issued under the Therapeutic Goods Act 1989) — this licence must match the specific goods being imported, and spot audits do occur
⚠Narcotic, psychotropic, and certain precursor substances require a permit from the Office of Drug Control (ODC) under the Narcotic Drugs Act before each shipment; permits are shipment-specific so plan lead times of 10–15 business days
⚠Biological medicines, vaccines, and any product of animal origin require DAFF biosecurity assessment and may need a Biosecurity Import Permit — cold-chain integrity documentation is also scrutinised at the border for temperature-sensitive biologics
⚠Goods exempt from ARTG registration (e.g. certain compounded medicines or personal use exemptions) still require a formal TGA exemption reference to be cited on the import declaration to avoid ABF detention
⚠No FTA exists between Australia and Hungary, so MFN (general) tariff rates apply to all imports. A commercial invoice and packing list are required; a formal certificate of origin is not needed to claim FTA preferences but may be requested by the ABF for origin verification purposes.
⚠ACMA type-approval and RCM (Regulatory Compliance Mark) labelling is mandatory for all electrical and electronic goods including machinery, consumer electronics, and telecommunications equipment before they can be sold in Australia.
⚠Pharmaceutical and medicinal products (Chapter 30) exported from Hungary, a significant EU pharmaceutical manufacturing hub, must meet TGA (Therapeutic Goods Administration) registration and importation requirements, including valid import permits for scheduled substances.
⚠Biosecurity declarations and potential DAFF inspection apply to any goods containing organic material, timber packaging, or animal-derived components. All wooden packaging must comply with ISPM 15 (heat treatment) standards, and a valid Biosecurity Import Conditions (BICON) assessment should be confirmed prior to shipment.

Key documents required

commercial invoice citing ARTG registration or listing number for each product line
TGA Import Licence or Manufacturing Licence copy (held by the importer of record)
Office of Drug Control (ODC) import permit for controlled substances (Schedule 8 or precursor chemicals)
Certificate of Analysis (CoA) and Manufacturer's Certificate of GMP Compliance or equivalent TGA-accepted GMP clearance
DAFF Biosecurity Import Permit and cold-chain temperature records for biologics, vaccines, or animal-derived products

Import tip

Lodge your ODC controlled substance import permit application at least three weeks before the vessel or aircraft departs origin — ODC permits cannot be expedited after shipment, and a single missing permit number on the import declaration will result in ABF referral and potential destruction of the consignment.

Calculate the total landed cost for Chapter 30 goods from Hungary — duty, GST, IPC, and biosecurity included.

Calculate Landed Cost Find HS Code with AI

Other product categories imported from Hungary

Ch.84Nuclear reactors, boilers, machinery and mechanical appliances; parts thereof Ch.85Electrical machinery and equipment and parts thereof; sound recorders and reproducers, television image and sound recorders and reproducers, and parts and accessories of such articles Ch.87Vehicles other than railway or tramway rolling-stock, and parts and accessories thereof Ch.90Optical, photographic, cinematographic, measuring, checking, precision, medical or surgical instruments and apparatus; parts and accessories thereof Ch.39Plastics and articles thereof Ch.73Articles of iron or steel