Section 14 consents for goods that do not comply with standards
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.
Section 19A approvals for addressing medicine shortages
In some circumstances medicines not on the Australian Register of Therapeutic Goods (ARTG) are approved for import and supply in Australia because:
- there is a shortage of a medicine registered in Australia; and
- the medicine is needed in the interest of public health.
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.
Unapproved product pathways
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.
These include:
- the Special Access Scheme (SAS) that allows certain health practitioners to access therapeutic goods (such as medicines, medical devices or biologicals) that are not included in the Australian Register of Therapeutic Goods (ARTG) for a single patient.
- the Authorised Prescriber (AP) Scheme allows authorised medical practitioners to supply therapeutic goods (such as medicines, medical devices or biologicals) that are not included in the Australian Register of Therapeutic Goods (ARTG) to a class of patients with a particular medical condition.
- avenues that provide for the importation into and/or supply in Australia of 'unapproved' therapeutic goods for use in a clinical trial.
More information