The TGA sponsor: who is responsible for a listed medicine

What a sponsor is

The Therapeutic Goods Act defines a sponsor by what it does. Under section 3, a sponsor of therapeutic goods is a person who:

• exports the goods from Australia, or arranges their export;
• imports them into Australia, or arranges their import; or
• in Australia, manufactures them, or arranges for someone else to, for supply in Australia or elsewhere.

The definition leaves out anyone who does those things on behalf of another person who is a resident of, or carries on business in, Australia. So a contract manufacturer making a product on behalf of an Australian brand isn't its sponsor: the brand that arranged the manufacture is.

Every medicine on the ARTG names its sponsor, and the ARTG can be searched by sponsor.

Who can be a sponsor

The TGA says "the sponsor must be a resident of Australia or be an incorporated body in Australia and conducting business in Australia", with a representative who lives here, and that sponsors "must be an Australian resident or carry on business in Australia to get a therapeutic good listed". Its organisation details form adds that sponsors "must maintain at least one Australian representative at all times".

That rules out sponsoring from abroad. The form says "Sponsors must be located in Australia", and the TGA says "overseas manufacturers are unable to sponsor medicines for supply to the Australian market". An overseas brand needs an Australian sponsor: its own Australian company, or an Australian resident or business that agrees to be the sponsor and take on the duties below.

A sponsor can work through an agent, which the TGA describes as "a regulatory affairs consultant offering services, including advice and assistance in relation to regulatory requirements". The agent can do the work, but the TGA says "the sponsor is responsible for ensuring that their medicine is compliant with all relevant legislation".

Becoming a sponsor

1. A Client ID. The TGA's organisation details form registers the company with the TGA. For a company it is signed by a director or the company secretary, who is added to TGA Business Services as an authorised representative, and it is sent to the TGA. The TGA's helpdesk emails the nominated representative within three working days.
2. TGA Business Services. A new sponsor registers for access to the portal where a listing is entered, validated, certified and paid for. The TGA has said a new TGA Business Services, reached through the Health Business Services portal, will go live in mid to late 2026 and replace the current system rather than run alongside it.
3. The listing. The sponsor applies, certifies and pays the application fee, $1,063 in 2026–27. The TGA published a checklist for new sponsors of listed medicines in May 2026, and our TGA listing guide covers the steps.

What the sponsor certifies

At listing, the sponsor makes the certifications in section 26A of the Act. Among them, it certifies that it holds the evidence for the medicine's indications and claims, and the TGA says applicants "must certify that all information in the medicine's ARTG entry is correct". The TGA doesn't evaluate the medicine before it goes on the ARTG: its system validates the listing, but the TGA relies on the certifications and can review the listing at any time after. More on the evidence in our claims and indications guide.

The sponsor's duties after the listing

The TGA sums up a listed medicine's sponsor's ongoing duties: "notify us of any changes through variation processes", "pay regulatory charges", "report any issues or adverse events" and "provide us any information that we request from you". In more detail:

Duty	What it means
Evidence	Hold the evidence for every indication and claim "at all times while your medicine is listed in the ARTG", and give it to the TGA when it asks.
Manufacturing	Every step made in a licensed facility in Australia, or under a TGA GMP clearance overseas, unless the step is exempt. Overseas, the sponsor obtains the clearance. More in our GMP clearance guide.
Records	Keep distribution records for five years, a condition of listing, and keep safety records for the life of the medicine and five years after it leaves the ARTG.
Adverse events	Report serious adverse reactions that happen in Australia as soon as possible, and no later than 15 calendar days after receiving them; significant safety issues within 72 hours.
Recalls	Start and run any recall, product alert or correction in Australia, under the TGA's Procedure for Recalls, Product Alerts and Product Corrections, in force since 5 March 2025.
The TGA's questions	Answer a request for information under section 31 of the Act in full by its due date. The TGA also picks some listed medicines for compliance review at random.
Charges	Pay the annual charge each financial year. A listing that has never had turnover is exempt, but the sponsor must declare $0 turnover each year between 1 and 22 July, or by 15 September with a late fee, or the exemption ends.
Advertising	Keep every ad within the Advertising Code and consistent with the ARTG entry. More in our advertising guide.
Changes	Apply to vary the listing when certain product details change.

When the duties aren't met

In the TGA's words, it "can cancel or suspend medicines from the ARTG for refusing or failing to comply with a condition", and it can cancel a listing whose sponsor doesn't answer a request for information in full by the due date. Some contraventions of the Act carry civil penalties of up to 5,000 penalty units for an individual or 50,000 for a body corporate, and criminal penalties can include 5 to 7 years' imprisonment and fines of up to 4,000 penalty units. For offences committed on or after 1 July 2026, a penalty unit is $364.

The TGA's published cases show how this plays out:

• A false certification. Caruso's Natural Health paid $12,600 under an infringement notice for a false or misleading certification that it held evidence for some of a children's eye-care product's indications.
• Evidence not held. Caruso's was also given five infringement notices, $82,500 in all, for an alleged failure to hold evidence for five therapeutic uses across three medicines.
• An information notice. Marvel Health (Australia) was fined $13,320 for an alleged failure to comply with a TGA request for information notice.

A false or misleading declaration of $0 turnover, to keep a listing exempt from the annual charge, is an offence under the Criminal Code.

Changing sponsor

• Within three months. A change of sponsor must be notified to the TGA within three months, on its "Notification: transfer of sponsorship" form, which the new and former sponsors should both sign. There is no fee, and the TGA usually updates the ARTG entries within 10 working days.
• The new sponsor is responsible at once. Its obligations start as soon as the transfer happens, even before the TGA is told, and it may be an offence for the former sponsor to keep supplying the goods.
• A new ABN or ACN counts. The TGA treats a change of ABN or ACN as forming a new business entity, so a restructure that creates a new ABN or ACN means a change of sponsor.

Where we come in

The sponsor is normally your company, and our advice is to sign as the company, not as an individual. We do the work behind what the sponsor certifies: the formula inside the permitted ingredients and indications, the evidence for every claim, the label, the stability program and the listing, then we manage the manufacture, with the licence or clearance each step needs. For brands already on the market we can run the regulatory work, as we have done for an international skincare brand on a monthly retainer since 2024. More on listed medicines, or book a call.