One asset, two labels — why shared Australian–New Zealand material is where off-label starts.

Most Australian affiliates are also New Zealand affiliates, and most of them share material across the Tasman. One detail aid, one leave-behind, one website with a country toggle. In September 2025 Medicines Australia published a Help Desk note on exactly this (#95), and its conclusion is not that shared assets are forbidden — it is that they are where off-label promotion most easily happens without anyone intending it.

What the note says

Four points, in the note's order.

The indications may differ. The two regulators approve independently, on different dossiers, at different times. A product can carry a wider indication in New Zealand than in Australia, or the same indication with a different population qualifier, a different line of therapy, a different age band.

Small wording differences are enough. The note's point is not the obvious one about a missing indication. It is that small differences in the PI wording — a qualifier present in one and absent in the other — can support off-label promotion in one country and not the other. The same sentence can be within the label on one side of the Tasman and outside it on the other.

A broader New Zealand indication cannot be promoted to Australian healthcare professionals. The ceiling in Australia is § OP 8: claims "consistent with the Australian Product Information document … irrespective of the source on which the claim is based". A New Zealand approval is a source; it does not lift the Australian ceiling.

Both indications on one piece is possible, qualified — and carries risk. The note allows a shared asset to carry both countries' indications if each is clearly qualified by jurisdiction. It is careful to say that this carries risk, because a reader in one country sees a claim made for the other.

It closes with the PBS point the Promotional Claims Guidance also makes: PBS listing details that are broader than the Australian PI may breach Therapeutic Goods legislation, on the TGA's advice — so a shared asset that prints Australian reimbursement detail has a second way to go wrong. And it requires compliance with both frameworks — the Medicines Australia Code here, the Medicines New Zealand Code there.

Why the shortcut fails quietly

A shared asset is usually built from whichever PI the writer had open, then "checked" against the other. The check tends to be a search for the indication paragraph. But consistency with the PI is tested on five things — indication, population, directions and limitations, dose and regimen, endpoints and safety — and the small differences the note describes live in the other four. A dosing table with a titration step one PI carries and the other does not; a safety summary with an adverse-event frequency from one label's trial section; a population line that says "adults" where one PI says "adults with [qualifier]". Each is consistent with one PI and off-label against the other, and a search for the disease name finds none of them.

The failure is quiet because the piece looks localised. The brand is right, the indication paragraph is right, the sponsor's address is right for both. Nothing on the page signals that a claim in the middle was written to the other market's label.

The other direction

New Zealand's own law used to be the stricter side: the Medicines Act prohibits promotion of unapproved medicines, so a product registered in Australia and not in New Zealand could not be promoted at a New Zealand conference at all. The Help Desk's note on New Zealand conference rules (#54, revised January 2026) records the change: from November 2025 a narrow statutory exemption permits advertising at accredited medical conferences and associated trade shows, subject to conditions — pre-notification to Medsafe, a healthcare-professional-only audience, clear disclosure that the medicine is not approved in New Zealand, and no distribution of promotional material outside the conference environment. Australian-registered medicines may now be promoted at a New Zealand conference where they are not New Zealand-approved, on those terms.

So the two directions are now asymmetric in an interesting way. Material for a New Zealand conference may carry an Australian-only product, with the disclosure. Material for Australia may never carry a New Zealand-only indication. A shared asset that tries to serve both needs to know which way it is travelling.

What to do with a shared master

Treat the shared master as a master, not a piece: the thing each country's version is adapted from, never the thing that ships. Then adapt each version to its own PI — the current one, for the presentation being promoted — on all five tests, not the first, and let each carry only its own funding line. Where a single asset genuinely must serve both, qualify every indication and every claim by jurisdiction, and read the result as a New Zealand prescriber would and as an Australian one would, separately.

That adaptation is a workflow of its own — the master in, the Australian PI beside it, every claim tested and rewritten or removed, the changes recorded. It is what Global to local describes and what the Localiser does: the same five tests, on every page, with the PI open. The find-and-replace version of it is where the Help Desk's note comes from.