Supply a medicine under special circumstances
Information about special circumstances that may allow a medicine to be imported, exported or supplied in Australia.
Under the Therapeutic Goods Act 1989 prior consent must be given under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not conform with an applicable standard.
For more information read our page on Consent to import, supply or export therapeutic goods that do not comply with standards - information for industry.
You can also search our Section 14 consents and Section 14, TGO91 consents databases.
In some circumstances medicines not on the Australian Register of Therapeutic Goods (ARTG) are approved for import and supply in Australia because:
For more information read our information on Supplying alternative medicines during a shortage and our page on Database of section 19A approvals to import and supply medicines to address medicine shortages.
You can also search our Section 19A approvals database.
The TGA administers various pathways that allow supply of medicines that are not included in the Australian Register of Therapeutic Goods (ARTG). These products are considered 'unapproved'. Further information is available at Unapproved therapeutic goods.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.
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