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Importing Pharmaceutical products from Denmark into Australia (2026)

Importing Chapter 30 pharmaceutical products from Denmark attracts MFN tariff rates with no FTA concession available, and every shipment must be backed by a current TGA Import Licence and confirmed ARTG registration before Australian Border Force will release the goods. For narcotic or psychotropic lines — common in Danish pharmaceutical exports — an ODC shipment-specific permit must be secured 10 to 15 business days ahead of vessel arrival.

No FTA — MFN rates applyHS Chapter 30

Compliance requirements

  • ⚠Verify ARTG registration for each specific product line before booking the shipment to avoid ABF holds at the border.
  • ⚠Obtain ODC permit well in advance for any narcotic or psychotropic lines; permits are shipment-specific and non-transferable.
  • ⚠Ensure commercial invoice explicitly declares Denmark as country of origin to satisfy MFN customs entry requirements.
  • ⚠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 Denmark, so MFN (general) tariff rates apply to all goods; a commercial invoice with accurate country of origin declaration is required for customs entry but no preferential certificate of origin is applicable
  • ⚠Pharmaceutical and medical device imports from Denmark must comply with TGA registration or listing requirements under the Therapeutic Goods Act 1989, with applicable permits obtained prior to importation
  • ⚠Electrical and electronic goods must meet Australian electromagnetic compatibility and electrical safety standards, with ACMA compliance labelling and state-based electrical safety approval (RCM mark) required before sale in Australia
  • ⚠Biosecurity declarations and DAFF inspection are mandatory for any goods containing timber, wood packaging material, dairy ingredients, animal-derived products or live biologicals, with ISPM-15 treatment required for all wood packaging

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 Denmark — duty, GST, IPC, and biosecurity included.

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Other product categories imported from Denmark

Ch.84Nuclear reactors, boilers, machinery and mechanical appliances; parts thereofCh.85Electrical machinery and equipment and parts thereof; sound recorders and reproducers, television image and sound recorders and reproducers, and parts and accessories of such articlesCh.87Vehicles other than railway or tramway rolling-stock, and parts and accessories thereofCh.90Optical, photographic, cinematographic, measuring, checking, precision, medical or surgical instruments and apparatus; parts and accessories thereofCh.33Essential oils and resinoids; perfumery, cosmetic or toilet preparationsCh.22Beverages, spirits and vinegar