Lodging an AUST L listing in TGA Business Services

This walkthrough assumes no prior TGA Business Services (TBS) experience. It explains the lodgement process step by step. It is a guide to the mechanics of lodging — it does not make regulatory judgments about your product, and completing these steps is not a guarantee of listing. Confirm current requirements at tga.gov.au as you go.

Before you start

You will need: an active TBS account and TGA client ID for the sponsoring organisation; your formulation details (every ingredient and quantity); the permitted indications you intend to carry; evidence held for each indication; and GMP evidence (an Australian manufacturing licence, or a TGA GMP clearance for each overseas site).

Step 1 — Set up your TBS account and client ID

1. Go to TGA Business Services and register your organisation if you have not already.
2. Obtain your TGA client ID — this identifies the sponsor on every application.
3. The sponsor must be an Australian entity that will hold legal responsibility for the goods.

First-time organisation setup can take time — start it well before you intend to lodge.

Step 2 — Start a new listed medicine application

1. In TBS, choose to create a new application for a Listed medicine (AUST L).
2. Select the application type appropriate to a new listing.
3. Enter the product name and dosage form.

Step 3 — Enter your formulation

1. Add each active ingredient and its quantity per dosage unit.
2. Add excipients as required.
3. Every ingredient must be a permissible ingredient used within its requirements. Your Submission Pack's completeness pre-check flags any ingredient that is not permissible or is scheduled — resolve those before lodging.

Step 4 — Select your permitted indications

1. Choose your indications from the permitted indications list in TBS. A listed medicine may only carry permitted indications, entered verbatim.
2. For any indication that carries a required qualifier or label statement, note it — your pack's checklist surfaces these from the determination.
3. You certify that you hold evidence for each indication. Organise it using the Evidence Summary template in your pack. You are not lodging the evidence, but the TGA can request it.

Step 5 — Certifications

TBS will ask you to make a series of certifications — that ingredients are permissible, that the product is manufactured under appropriate GMP, that you hold evidence for your indications, and that the label and advertising comply. These certifications are legal declarations by the sponsor.

Step 6 — Review, pay and submit

1. Review every entered detail against your formulation and label.
2. Pay the application fee (an annual charge also applies).
3. Submit. An AUST L number is issued on successful listing — it is largely an automated process, so your certifications carry the responsibility.

After listing

Keep your evidence current and retained. Your label and all advertising must continue to comply and must only use your permitted indications. Post-market, the TGA can review any listed medicine and request your held evidence.