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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.
New guidance is being developed about exporting medicines from Australia.
- Frequently asked questions about exporting medicines
These FAQs provide answers to common questions about exporting medicines
- If you have a specific question contact Exports
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).
The TGA will accept electronic submissions of schedules to accompany the Certificate of Pharmaceutical Product (CPP) and Certificate of Listed Product (CLP).
If additional certification is required by the importing country, medicine sponsors can apply to the TGA for a Certificate of Pharmaceutical Product (CPP) or a Certificate of Listed Products (CLP). 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 and CLP are submitted electronically through TBS.
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.
- Certificates of free sale and export certificates for medical devices
Guidance about applying for a certificate of free sale and export certificate for a medical device
- Application for a certificate of free sale or export certificate for a medical device
Use this form to apply for a certificate of free sale or export certificate for a medical device
- Frequently asked questions about exporting medical devices
These FAQs provide answers to common questions about exporting medical devices
The TGA issues permits for exporting human substances, under the Customs (Prohibited Exports) Regulations 1958 (Regulation 8).
- Export of human substances
Guidance about exporting human substances and how to apply for a TGA export permit
- Application for a permit to export human substances
Use this form to apply for a permit to export human substances
- Frequently asked questions about exporting human substances
Answers to common questions about exporting human substances
Unapproved therapeutic goods
There are certain circumstances where unapproved therapeutic goods that are not in the ARTG can be legally exported.
- Import/export of unapproved therapeutic goods for experimental purposes
Guidance and application form for exporting unapproved therapeutic goods for clinical trials
- Named Patient Program
Allows for the export of unapproved therapeutic goods for named patients overseas. For further information, contact the Experimental Products Section
- Frequently asked questions about exporting unapproved therapeutic goods
Answers to common questions about exporting unapproved therapeutic goods
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:
- check the list of controlled substances that require a licence and permit to export
- contact the Office of Drug Control
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.
Therapeutic Goods Administration
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Therapeutic Goods Administration