Role of the sponsor

28 March 2013

A sponsor is a person or company who does one or more of the following:

• exports therapeutic goods from Australia
• imports therapeutic goods into Australia
• manufactures therapeutic goods for supply in Australia or elsewhere
• arranges for another party to import, export or manufacture therapeutic goods.

A full definition is provided in Chapter 1 Section 3 of the Therapeutic Goods Act 1989.

The sponsor is responsible for applying to the TGA to have their therapeutic good included on the Australian Register of Therapeutic Goods (ARTG). In Australia, therapeutic goods must be included on the ARTG before they can be sold.

The sponsor must be a resident of Australia or be an incorporated body in Australia and conducting business in Australia where the representative of the company is residing in Australia.

For information on the role and responsibilities of a sponsor, as well as information on how to apply for an entry on the ARTG, please refer to:

• The Australian regulatory guidelines for prescription medicines (ARGPM)
• The Australian regulatory guidelines for OTC medicines (ARGOM)
• The Australian regulatory guidelines for complementary medicines (ARGCM)
• The Australian regulatory guidelines for medical devices (ARGMD)