Does each new product need its own TGA listing?

A product with a different active ingredient, a different quantity of one or a different dosage form does: in the TGA's change tables those are new medicines. A version that differs only in flavour, colour, fragrance or printing ink is a grouping application instead, at the same fee as a new product.

Do we pay the annual charge before a new product sells?

Not while it has never had turnover. A listing stays exempt until sales start, as long as the sponsor declares, between 1 and 22 July each year, that it had none in the year before.

Can one range mix medicines, foods and cosmetics?

Yes. Each product follows its own pathway: Vitable's range pairs a TGA-listed capsule with a cosmetic serum, and ATP Science's pairs listed capsules with a food-pathway powder.

Can our current manufacturer make the new product?

If its licence, or its GMP clearance for a site overseas, covers the new product's dosage form and every step it will carry out. If not, we match the product to a partner that is, and adding a manufacturer is an update to the ARTG record, with no fee.

How long does the next product take?

It depends on the formula, the format and the pathway, as the first one did. From our records, listed medicines have taken 32 days to 12 weeks from design to production order. See how long it takes.

Product development

Extending a supplement range: your next product, and the one after

In short

In the TGA's change tables, a product with a different active ingredient, a different quantity of one or a different dosage form is a new medicine: a new listing, with its own application fee and, once it sells, its own annual charge.
A version that differs only in its flavour, colour, fragrance or printing ink is a grouping application instead, charged at the fee for a new product.
A listing that has never had turnover stays exempt from the annual charge until sales start, as long as the sponsor declares, between 1 and 22 July each year, that it had none in the year before.
What carries over: your sponsor, your manufacturing partners and suppliers, and the way your evidence and labels are built. What starts again: each product's formula, evidence, listing, label and stability program.
From our records: nine products for BWellness, a second product for EverLeanBody, and a range of five planned around The Belly Solution's first hero product.

What carries over, and what starts again

Carries over from your first product	Starts again for each new one
The brand, its customers and its channels	The formula and its specification
The sponsor and its systems	The evidence for every claim
Manufacturing partners already making for you, where their licence or clearance covers the new dosage form and steps	The listing on the ARTG, and its fees
Packaging and ingredient suppliers	The label
How the evidence, the label and the stability program are built	The stability program

The TGA side of each kind of extension

A new product. Adding, replacing or removing an active ingredient, changing an active's quantity or changing the dosage form all make a new medicine in the TGA's change tables: a new listing. What a listing costs is in our development cost guide.
A new flavour, colour or fragrance. A change to flavour, colour, fragrance or printing ink only is a grouping application for a listed medicine, at the same fee as a new product.
A product on another pathway. A range can cross pathways. Vitable's TGA-listed capsule has a matching serum on the cosmetics pathway, and ATP Science's four listed capsules sit beside a performance powder on the food pathway. Each product follows its own pathway's rules (medicine, food or cosmetic?).
The same manufacturer. A manufacturer can make the new product if its TGA licence, or its GMP clearance overseas, covers the new dosage form and every step it will carry out. Adding or changing a manufacturer is an update to the ARTG record, with no fee. More in choosing a supplement manufacturer.
A sample or trial pack. From our records: a 7-day sample pack for Arxi's preconception capsule, for events and sampling, and a trial pack beside the 60-count pack of an eye-health formula.

Planning the range

Plan the range, then build it a product at a time. The Belly Solution started as a new company with a range of five products in mind, and launched one hero product first: a TGA-listed travel gut-health powder that went into a national pharmacy distribution trial, with more than 30 new stockists in its first week. Design each product to its price before the formula is fixed (design to the price), and keep the products already selling in stock: a range grows on its reorders.

From our records

BWellness: nine products for the same practitioner brand, including an immune powder built on Wellmune® and an algal omega-3 capsule built on life's®OMEGA with VitaShine™ vegan vitamin D3. Five production batches from 2021 to 2025, and a sixth order in the pipeline.
EverLeanBody: after its first capsule, 5.8 months from signed brief to dispatch, a second product built on Eriomin®, a clinically studied lemon flavonoid extract, now in development with us.
The Belly Solution: a first hero product from a planned range of five, with a second batch now ordered.
Arxi: a preconception capsule with three production orders since 2024, a 7-day sample pack, then a prenatal chewable, in production now.
An eye-health brand: nine products developed and quoted, spanning eye health, omega-3s, probiotics, liver, immune, prostate and more, with three taken into production.
A sports nutrition brand: a joint-support formula brought into its range as a TGA-listed medicine, delivered in 2023, alongside further products we scoped for the brand.
An international skincare brand: two supplements and a sunscreen, with stability studies out to 36 months, and its regulatory work on a monthly retainer since 2024.

Questions

: A product with a different active ingredient, a different quantity of one or a different dosage form does: in the TGA's change tables those are new medicines. A version that differs only in flavour, colour, fragrance or printing ink is a grouping application instead, at the same fee as a new product.
: Not while it has never had turnover. A listing stays exempt until sales start, as long as the sponsor declares, between 1 and 22 July each year, that it had none in the year before.
: Yes. Each product follows its own pathway: Vitable's range pairs a TGA-listed capsule with a cosmetic serum, and ATP Science's pairs listed capsules with a food-pathway powder.
: If its licence, or its GMP clearance for a site overseas, covers the new product's dosage form and every step it will carry out. If not, we match the product to a partner that is, and adding a manufacturer is an update to the ARTG record, with no fee.
: It depends on the formula, the format and the pathway, as the first one did. From our records, listed medicines have taken 32 days to 12 weeks from design to production order. See how long it takes.