Why do I need a product sponsor in Australia?

Manufacturers of medicines and medical devices who are not located in Australia must have an in-country representative, a Sponsor, to enable Marketing Authorisation by
Australia’s Therapeutic Goods Administration (TGA).

A Sponsor is required by law if your company:

• Exports or arranges the export of therapeutic goods from Australia
• Imports or arranges the import of therapeutic goods into Australia
• Manufactures therapeutic goods for supply in Australia or elsewhere

Your Sponsor plays an important role in the registration process and post-market compliance.

With a physical office in Melbourne, Australia, Maxx Pharma acts as an established provider of Sponsorship Services for manufacturers of medicines and medical devices located throughout the world.

Sponsors have ongoing legal responsibilities once a therapeutic good is on the ARTG

Your Sponsor in Australia acts as a liaison between you and the TGA, as specified by the Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulations 2002. Your Sponsor assumes regulatory representation for your product in the Australian market and is responsible for registration with the TGA.

Ongoing legal obligations for sponsors include:

• Obtaining information from the manufacturer when requested by the TGA
• Providing information to the TGA on request and within required legislative timeframes
• Ensuring all manufacturers hold a relevant manufacturing license, clearance, certification or conformity assessment certificate, as required
• Ensuring the information supplied to the TGA is complete and correct
• Paying annual charges to maintain the ARTG entry while the therapeutic good is supplied on the ARTG
• Applying to, or notifying, the TGA of any changes to the therapeutic good, if required
• Complying with:
  • any conditions imposed on the supply of the therapeutic goods
  • the requirements for advertising therapeutic goods
  • requirements for records of distribution and supply
  • pharmacovigilance requirements
• Notifying the TGA of adverse events or problems with the therapeutic goods they sponsor
• Notifying the TGA of an issue that requires corrective action, such as a recall
• Undertaking recall actions relevant to the therapeutic goods supplied, where necessary

Maxx Pharma provides sponsorship services for manufacturers not based in Australia

To maintain direct control of the registration of your therapeutic good, it is recommended that you appoint a “third party” Sponsor who is not commercially involved in the sale of your products and acts solely as your regulatory representative in Australia.

In acting as a product sponsor in Australia, Maxx Pharma:

• Sponsors products for manufacturers that do not have an established legal entity in Australia
• Acts as a local primary point of contact with the TGA
• Submit applications to add a therapeutic good on the Australian Register of Therapeutic Goods (ARTG)
• Maintains sponsorship after registration or listing on the ARTG
• Undertakes ongoing legal responsibilities once the therapeutic good is on the ARTG
• and fulfilling the obligations of the sponsor

About Maxx Pharma

As a provider of Sponsorship Services, Maxx Pharma is a wholly owned subsidiary of Commercial Eyes Pty Ltd.

Commercial Eyes is Australia’s leading pharmaceutical and medical device commercialisation company. With a team of over 100 people, with expertise in Regulatory, Quality & Compliance, Access, Research & Intelligence, Patient Safety & Risk Management, Medical Information and Patient Programs.

Contact us at [email protected] to discuss your sponsorship needs, or options for entering the Australian market.

Maxx Pharma: https://maxxpharma.com.au/
Commercial Eyes: https://commercialeyes.com.au/