How to Import Pharmaceuticals to Australia

Step-by-Step Import Process

1. 1

   Determine TGA classification

   Identify how your product is classified under the Therapeutic Goods Act 1989: prescription medicine, over-the-counter medicine, complementary medicine, medical device (Class I to III), or biological. The classification determines the registration pathway and the level of evidence required.

2. 2

   Register the product on the ARTG

   Apply to the TGA for inclusion on the Australian Register of Therapeutic Goods. This involves submitting a dossier of safety, quality, and efficacy data. For prescription medicines, a full evaluation (Category 1) can take 12+ months. Listed medicines (complementary) have a shorter pathway. Medical devices follow a separate conformity assessment process.

3. 3

   Ensure GMP compliance of the manufacturing facility

   The overseas manufacturing facility must be GMP-compliant and cleared by the TGA. The TGA conducts GMP inspections of overseas manufacturing sites, or accepts GMP clearances from recognised regulatory authorities (e.g., FDA, EMA) through mutual recognition agreements.

4. 4

   Obtain import permits for controlled substances

   If your product contains a controlled substance (Schedule 8 drugs, precursor chemicals), you need an import permit from the Office of Drug Control (ODC). Permits are issued per shipment and require documentation of the quantity, source, and intended use.

5. 5

   Engage a licensed customs broker

   Choose a broker experienced with pharmaceutical imports. Pharmaceutical imports require coordination between the ABF, TGA, and potentially the ODC. Temperature-controlled supply chain management is also critical for many pharmaceutical products.

6. 6

   Prepare import documentation

   Assemble commercial invoices, packing lists, airway bills or bills of lading, TGA registration details (ARTG number), GMP clearance evidence, and any ODC import permits. For temperature-sensitive products, include cold chain documentation showing the product has been maintained within specified temperature ranges.

7. 7

   Clear customs and maintain cold chain

   Your customs broker lodges the import declaration. Pharmaceutical shipments must clear customs promptly to maintain product integrity — cold chain breaks can render temperature-sensitive medicines unusable. Pay customs duty (most pharmaceuticals are duty-free) and GST, then transfer to TGA-licensed premises.

Key Regulations

The TGA administers the Therapeutic Goods Act 1989, which requires all therapeutic goods to be included in the ARTG before import or supply. The Act establishes categories of registration (registered, listed, included) with different levels of pre-market evaluation.

GMP compliance is mandatory for manufacturers of therapeutic goods. The TGA's PIC/S (Pharmaceutical Inspection Co-operation Scheme) membership enables mutual recognition of GMP inspections with other member countries, reducing duplication.

The Office of Drug Control (ODC) regulates the import of controlled substances under the Narcotic Drugs Act 1967 and Customs (Prohibited Imports) Regulations 1956. Import permits are required for Schedule 8 and Schedule 9 substances and certain precursor chemicals.

The Therapeutic Goods (Medical Devices) Regulations 2002 establish the conformity assessment framework for medical devices, which follows a risk-based classification system (Class I to Class III) similar to the European system.

Duties & Tariffs

Most pharmaceutical products enter Australia duty-free under tariff concessions for medicines and medical devices. This reflects Australia's participation in the WTO Pharmaceutical Tariff Elimination Agreement.

GST of 10% applies to the customs value of imported pharmaceuticals. Pharmaceutical Benefits Scheme (PBS) medicines have specific pricing and subsidy arrangements that are separate from customs duty.

Medical devices may attract customs duty depending on their tariff classification — some enter duty-free, while others attract 5% duty. Check the specific classification for your device.

Official Sources

Verify the information in this guide against these official government resources.

• TGA — How to Import Therapeutic Goods

  TGA guide to importing therapeutic goods including medicines and medical devices.

• TGA — Australian Register of Therapeutic Goods

  Search the ARTG to check whether a product is registered for supply in Australia.

• Office of Drug Control — Import/Export Licences

  Permit requirements for importing controlled substances and precursor chemicals.

• TGA — GMP Clearances

  How overseas manufacturing sites obtain GMP clearance from the TGA.