Role of Sponsor
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.
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.
MAH Requirements:
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.
MAH Responsibility
Interactions with Therapeutic Goods Administration (TGA).
Responsible for the authenticity of documents and correctness of information.
License holding and maintenance activities.