Getting a listed medicine (AUST L) manufactured in Australia: an overview
A general overview of how a listed medicine (AUST L) usually gets made in Australia, who is responsible for what, and where a TGA GMP licensed contract manufacturer fits.
This overview explains, in general terms, how a listed medicine usually moves from idea to finished product, and where a contract manufacturer fits. It is not regulatory advice. Your product’s regulatory pathway, ingredients, claims and labels are decisions for you as the sponsor, ideally with a regulatory consultant.
Who does what
A listed medicine appears on the Australian Register of Therapeutic Goods (ARTG) with an AUST L number. The sponsor, usually the brand owner, holds the listing and is responsible for the product’s compliance. The manufacturer makes the product under its own TGA GMP licence, to the specification the sponsor approves.
1. Confirm the regulatory pathway
Whether a product can be listed depends on its ingredients and claims. The TGA publishes the rules, including its permitted indications. A regulatory consultant can confirm the right pathway for your product. We don’t make this assessment for clients.
2. Settle the formula and dosage form
Decide the actives and amounts per dose, then the format: capsule, tablet, powder, sachet, liquid or cream. A manufacturer can help with manufacturability, such as fill weights, excipients and pack format, but not with regulatory status.
3. Choose a TGA-licensed manufacturer
Australian manufacturers of listed medicines hold a TGA GMP licence covering the steps they perform. Ask any manufacturer to confirm their licence covers your dosage form and the steps you need.
4. Evidence, labels and listing
The sponsor holds the evidence for the product’s claims, prepares the label and lists the product on the ARTG. The TGA’s guidance on listed medicines explains these requirements.
5. Manufacture and packing
With the specification approved, the manufacturer produces batches under GMP with batch records and release testing, then packs them in the agreed format.
Where DB Pharmaceuticals fits
DB Pharmaceuticals manufactures and packs listed medicines under its TGA GMP licence in Kings Park, Sydney: capsules, tablets, powders, liquids and creams. We don’t provide regulatory, claims or labelling advice. See listed medicine manufacturing or call 02 9672 3222.
This guide is general information only. It is not regulatory or legal advice, and requirements change. Check current requirements with the TGA or a qualified regulatory consultant before making decisions about your product.