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Exporting therapeutic goods

To export therapeutic goods from Australia for commercial purposes, you must meet certain regulatory requirements set out in the Australian therapeutic goods legislation. The goods must be entered in the Australian Register of Therapeutic Goods (ARTG) before you can legally export them, unless they are exempt from being entered in the ARTG.

Every ARTG entry belongs to a 'sponsor' who is responsible for applying for and maintaining the ARTG entry. If you are planning to export a therapeutic good for commercial supply overseas, you must be the sponsor named in the ARTG entry for that good, or an authorised agent acting on behalf of the sponsor.

Medicines

New guidance is being developed about exporting medicines from Australia.

Export only medicines

Export only products are required to be listed (not registered) on the ARTG before export. The purpose of an export only listing is to ensure that all products exported from Australia comply with standards that are similar to the standards applied to products supplied in Australia.

Applications for new export only medicines, groupings or variations are submitted electronically through TGA Business Services (TBS).

Export certification

If additional certification is required by the importing country, medicine sponsors can apply to the TGA for a Certificate of Pharmaceutical Product (CPP), a Certificate of Listed Products (CLP) or a Certificate of Exempt Product (CEP). These certificates are issued under section 58 of the Act and are based on the World Health Organisation (WHO) scheme on the quality of pharmaceutical products moving in international commerce.

Applications for CPP, CLP or CEP are submitted electronically through TBS.

Medical devices

The Australian regulatory guidelines for medical devices (ARGMD) are currently under review.

Certificates of free sale and export certificates are documents supplied by the Therapeutic Goods Administration (TGA) outlining that the relevant products are included in ARTG and are either able to be freely sold within Australia or are able to be exported from Australia.

Human substances

The TGA issues permits for exporting human substances, under the Customs (Prohibited Exports) Regulations 1958 (Regulation 8).

Unapproved therapeutic goods

There are certain circumstances where unapproved therapeutic goods that are not in the ARTG can be legally exported.

Controlled substances

The Office of Drug Control, as part of the Australian Government Department of Health, regulates and provides advice on the export of controlled substances from Australia.

Controlled substances (such as narcotic, psychotropic and precursor substances) are prohibited for export without a licence and permit under the Customs (Prohibited Exports) Regulations 1958.

To export a therapeutic good that contains a controlled substance you need a licence and permit from the Office of Drug Control.

If you are unsure if the good you are exporting contains a controlled substance you should:

If you are travelling overseas as part of a sporting team, military exercise, medical emergency team or medical aid mission, or are travelling with a medical kit, you should contact the Office of Drug Control for further information. In addition, we suggest you contact the country to which you will be travelling to ensure you meet their importation requirements.

Contact details for enquiring about exporting therapeutic goods

If your enquiry is not about exporting therapeutic goods, see: Contact the TGA.

Email
Phone
  • 1800 020 653 (free-call within Australia)
  • +61 2 6232 8544 (international callers)
  • Users with a hearing or speech impairment can call through the National Relay Service:
    • TTY or computer with modem users: phone 1800 555 677 then ask for 1800 020 653
    • Speak and listen (speech-to-speech relay) users; phone 1800 555 727 then ask for 1800 020 653
Postal address

Therapeutic Goods Administration
PO Box 100
Woden ACT 2606
Australia

Street address (for deliveries)

Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609
Australia