Importing/exporting therapeutic products for commercial purposes
Exporting
Importing therapeutic products into Australia for commercial purposes
Most products for which therapeutic claims are made must be listed or registered in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. (Some exceptions do exist).
See Prescription medicines <http://www.tga.gov.au/pmeds/pmeds.htm>, OTC medicines <http://www.tga.gov.au/npmeds/npmeds.htm> or Complementary medicines <http://www.tga.gov.au/cm/cm.htm> (depending on the type of medicine you are intending to import) or Medical devices <http://www.tga.gov.au/devices/devices.htm> for information on listing or registering products on the ARTG.
Why can't my product (or a product I am trying to import), which is sold freely in the USA and Europe, be sold here without having to go through the process of registering? Why are some substances considered to be foods in other countries considered to be therapeutic goods in Australia?
Just as Europe, the USA and other countries maintain the authority to decide which goods should be available in their country, so too does the Australian Government maintain its sovereignty in therapeutic goods regulation. However, agreements have been reached with some other countries to exchange information in order to facilitate the registration process.
Exporting therapeutic goods from Australia for commercial purposes
- Frequently asked questions about exporting therapeutic goods
<http://www.tga.gov.au/docs/html/export/exportfaq.htm> - Exporting medicines from Australia (overview)
<http://www.tga.gov.au/docs/html/export/expmed.htm> - TGA policy for the export of medicines from Australia
<http://www.tga.gov.au/docs/html/export/exppol.htm> - Exporting medicines from Australia - operational guidelines
<http://www.tga.gov.au/docs/html/export/expopgui.htm> - Export of medicines for commercial supply
<http://www.tga.gov.au/docs/html/export/expmedcomm.htm> - Export of medicines for donation or humanitarian purposes
<http://www.tga.gov.au/docs/html/export/expmeddon.htm> - Therapeutic Goods Order No. 70B - Standards for export only medicine
<http://www.tga.gov.au/docs/html/tgo/tgo70b.htm> - Certificate of Listed Product, Certificate of Pharmaceutical Product and Certificate of Exempt Product
<http://www.tga.gov.au/docs/html/export/clpapp.htm> - Avoiding rejections of export listing or certificate applications
<http://www.tga.gov.au/docs/html/export/cpprej.htm>
Exporting blood & tissues
- Export of human blood/tissue and related materials (including bodies & cremated remains)
<http://www.tga.gov.au/docs/html/export/expblood.htm>
Forms for exporters
Medical devices
- Application for certificate of free sale or export certificate for a therapeutic device/medical device
<http://www.tga.gov.au/devices/cfs-expc.htm>
Medicines
The application forms for Listing or Variation of Export Medicines and Certificates of Pharmaceutical Products are no longer available on this website. Sponsors are now required to use the Export Electronic Lodgement (EEL) system <http://www.tgasime.health.gov.au>, which is part of the TGA's Online Services, to apply for inclusion of new export medicines or varying existing export medicines in the Australian Register of Therapeutic Goods (ARTG), or to seek certificates of pharmaceutical products for their listed/registered products.
Can I use paper-based application forms to lodge an export application?
Paper based application forms are no longer accepted by the TGA Export Unit unless a genuine need is identified by a sponsor. Sponsors are required to apply for listing new medicines or obtaining certificates of pharmaceutical products through TGA Online Services, applying by submitting electronic applications.
If you are unable to use EEL for drafting and/or submitting an export application, please call 1800 092 788 and a paper application will be promptly mailed out to you.