Does changing a supplement's formula need a new TGA listing?

Usually, if an active ingredient or its quantity changes, the dosage form changes, or an excipient changes for any purpose other than flavour, colour, fragrance or printing ink: in the TGA's change tables, those make a new medicine. A change to flavour, colour, fragrance or printing ink only is a grouping application.

Can we change manufacturer without a new listing?

Yes. Changing or adding a manufacturer is an update to the ARTG record, with no fee. Every step still has to be made at a site with a TGA licence in Australia, or under a TGA GMP clearance overseas, unless the step is exempt. See choosing a supplement manufacturer.

Does a reformulated product need new stability data?

A new formula does. TGA guidance says a listed medicine's sponsor should hold stability evidence at or before listing, showing the product meets its specifications, stored as its label says, until its expiry date. See stability testing.

How long does a reformulation take?

From our records, the second version of a probiotic skin supplement took 12 weeks from design to production order. One that needs a new ingredient approved first takes longer: the law allows 40 working days for the TGA's preliminary assessment, then 70 to 180 working days for the evaluation (new ingredient applications).

Can you reformulate a product another company developed?

Yes. ATP Science's capsules were among its best-known existing formulas. We rebuilt them from scratch, then handled the TGA listings, stability protocols and label review, and managed manufacturing.

Product development

Reformulating a supplement: when a product has to change

In short

In the TGA's change tables, adding, replacing or removing an active ingredient, changing an active's quantity, changing the dosage form, or changing an excipient for anything other than flavour, colour, fragrance or printing ink makes a new medicine: a new listing.
A change to flavour, colour, fragrance or printing ink only, to the indications only or to the name only is a grouping application, at the fee for a new product.
Changing or adding a manufacturer, or changing the type of container, is an update to the ARTG record, with no fee.
A new formula needs stability evidence of its own: TGA guidance says the sponsor should hold it at or before listing, showing the product meets its specifications until its expiry date.
From our records: four ATP Science capsules reformulated from scratch, in a five-product range with reorders on three within a year; Pump Haircare's upgraded formula with a full new listing package, shipped in 2026; and the second version of a probiotic skin supplement, from design to production order in 12 weeks.

Why products are reformulated

From our records, for seven reasons:

Ingredient quality, dose and claims. Several of ATP Science's best-known formulas had room to improve on ingredient quality, dose and permitted indications. We reformulated four TGA-listed capsules from scratch, one built on Testofen®, a clinically studied fenugreek extract.
A range that grew. Pump Haircare's first TGA-listed hair growth formula has been reordered since 2021. As the range grew, we built an upgraded version with a full new listing package and stability testing, shipped in 2026.
A new version of a program. A skin brand's daily supplement, the second version of its formula, with probiotics at its core: a two-a-day product, from design to production order in 12 weeks, shipped in 2025.
A format that won't hold. An eye-health formula kept failing in encapsulation because the mix was too wet. We moved it to a direct-compression tablet and designed the stability protocol for a three-year expiry.
Taste and stability. Arxi's prenatal started as a liquid drop that wasn't stable and couldn't have its taste masked. We traced the main odour to one selenium form and removed it, then moved to a two-a-day chewable with Rocoat® coated B vitamins.
Supply. For a prenatal built on plant powders, we sourced a replacement supply of the formula's lead plant ingredient.
A new dose standard. An eye-health formula's vitamin E was set to the AREDS2 level before it was built.

What the TGA treats as a new medicine

The TGA's change tables set out how each change to a listed medicine is made.

Change to a listed medicine	How it's made
Add, replace or remove an active ingredient	New listing
Change an active ingredient's quantity or concentration	New listing
Change the dosage form, such as a capsule to a tablet	New listing
Change, add or remove an excipient for any purpose other than flavour, colour, fragrance or printing ink	New listing
Change the product name and the indications together	New listing
Change the flavour, colour, fragrance or printing ink only	Grouping, at the fee for a new product
Change the indications only, or the name only	Grouping
Change or add a manufacturer, or the steps it carries out	ARTG record update, no fee
Change the type of container	ARTG record update, no fee

The tables are the TGA's guidance, version 2.2 of March 2022. We check the current version, and the product's own entry, before a change is designed.

What a reformulation involves

The same work as a new product, built on what you already have: the formula and its specification, the evidence for each claim, the listing (new, grouped or updated), the label, the stability program and the manufacturing run. For Pump Haircare's upgrade, that meant a full new listing package and stability testing. For ATP Science, it meant TGA listings, stability protocols and label review across four capsules, with manufacturing managed through a co-packer delay, then reorders on three of the range's five products within a year.

A changed formula is also a chance to check it against the rules as they stand now. The Permissible Ingredients Determination changes: there have been three determinations in 2026 alone, and each can change an ingredient's limits or required statements (permissible ingredients).

Questions

: Usually, if an active ingredient or its quantity changes, the dosage form changes, or an excipient changes for any purpose other than flavour, colour, fragrance or printing ink: in the TGA's change tables, those make a new medicine. A change to flavour, colour, fragrance or printing ink only is a grouping application.
: Yes. Changing or adding a manufacturer is an update to the ARTG record, with no fee. Every step still has to be made at a site with a TGA licence in Australia, or under a TGA GMP clearance overseas, unless the step is exempt. See choosing a supplement manufacturer.
: A new formula does. TGA guidance says a listed medicine's sponsor should hold stability evidence at or before listing, showing the product meets its specifications, stored as its label says, until its expiry date. See stability testing.
: From our records, the second version of a probiotic skin supplement took 12 weeks from design to production order. One that needs a new ingredient approved first takes longer: the law allows 40 working days for the TGA's preliminary assessment, then 70 to 180 working days for the evaluation (new ingredient applications).
: Yes. ATP Science's capsules were among its best-known existing formulas. We rebuilt them from scratch, then handled the TGA listings, stability protocols and label review, and managed manufacturing.