How can Maxx Pharma assist you?

Maxx Pharma is an Australian registered company that can act as a third party sponsor for companies by:

  • Sponsoring companies that do not have an established legal entity in Australia
  • Submitting an application to add a therapeutic good on the Australian Register of Therapeutic Goods (ARTG)
  • Maintaining sponsorship after registration or listing on the ARTG
  • Undertaking ongoing legal responsibilities once the therapeutic good is on the ARTG and fulfilling the obligations of the sponsor

Once a product is entered in the Australian Register of Therapeutic Goods

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

  • 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 licence, 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