One click, or two? — the PI, the PBS line, and what 'immediately' means.

Of the seven inclusions every promotional piece must carry, two generate most of the questions: the statement that sends a prescriber to the Product Information, and the statement of funding status. The Code's words on each are short — "a statement directing healthcare professionals to review Product Information (PI) before prescribing", including "the means for healthcare professionals to access the PI immediately in electronic or other form, or the telephone number for the Company medical information service" § 2.1(d); and "a statement indicating the public funding or reimbursement status of the product, with or without details of listing, or a direction to where the relevant information is available" § 2.1(e). The questions are about immediately and with or without. Medicines Australia has answered them, in four Help Desk notes and the Tool Kit's Prescribing Information Guidance.

How many clicks

The Help Desk's note on mandatory information (#13) is the one everybody half-remembers as "one click". Its actual position is that the one-click yardstick is helpful but not absolute. A single click or scan may take the reader to a landing page that carries other things — a corporate product listing, a digital summary — provided the mandatory information is prominent, upfront and obvious on that page. What the principle prevents is making a prescriber search for the PI.

The Prescribing Information Guidance (March 2025) restates it: the Code does not prescribe one click or one scan, but the intent is that the PI is very easily accessible, and on whatever page the link lands, the PI should be upfront and obvious. Three mechanics follow from it. A QR code or URL must link directly to the approved PI — not to a search engine, not to the corporate home page. The code or link should be accompanied by text that draws the reader's attention to it, so that a square of black pixels in the corner reads as "the PI is here". And the link is not balance: the piece itself must carry enough for a proper assessment of risks and benefits § OP 7, § 1.1 — a QR code to the PI does not excuse a benefit panel with no risk beside it.

For digital formats the Guidance adds two rules of counting. "Paired" advertisements for the same product seen in one spread or one view may be treated as a single advertisement, and a scrolling online banner is one advertisement — so the inclusions need appear once. But an advertisement without a claim that directs the reader to a summary in a second advertisement some pages away is two pieces, and each carries the access statement and the means.

Is the PBS box still a box?

Edition 19's habit was a bordered "PBS Information" panel with the restriction text inside it. The Help Desk's note (#32) is explicit that Edition 20 asks for no such thing: § 2.1(e) requires a statement of funding status "with or without details of listing, or a direction to where the relevant information is available", and there is no requirement for the box format. The note offers a minimal compliant form — a line that the product is PBS listed, with a direction to the PBS website for the full authority information — and names the principle as prominence and accessibility rather than layout.

The choice between "with" and "without" details has a consequence beyond space. Where the PBS restriction is broader than the TGA indication, printing the restriction's terms in promotional material risks promoting outside the PI, and the Promotional Claims Guidance records the TGA's advice to Medicines Australia to that effect. The safe statement is the short one. Where the restriction is narrower, or the product is unfunded for one of its indications, the statement has to be accurate for the piece's use — a funding line that says "PBS listed" beside an unfunded indication is a § 2.1(e) finding, though never an off-label one.

When the mandatories don't apply

The Help Desk's note #47 answers the question in its title — are they always mandatory? — with two exceptions and a warning. The § 2.1 inclusions apply to product-specific promotional material directed to healthcare professionals. They do not apply to a consumer-facing media release on a registration, which is governed by § 10.1 and its own seven-item set § 10.1(e). And they do not apply to scientific exchange material between Medical Affairs and healthcare professionals, which is non-promotional by nature § 7 — though the Scientific Exchange FAQs add that including them does not make such material promotional, and that § OP 3 and § OP 7 still expect the information a prescriber needs.

The warning is the one worth pinning above the desk: balance and mandatories are not the same thing, and mandatories do not satisfy balance.

When a brand name is not promotion

The Glossary defines a promotional claim as a statement that "conveys the positive attributes of a product which extend beyond a simple non-qualitative or non-quantitative description of the therapeutic category or approved indication" § Glossary. The Help Desk's note #26 draws the practical line: a brand name alone is not promotion. It may appear in an e-mail subject line, in a gated HCP-only URL, on a business card or an envelope without triggering the inclusions — provided nothing around it makes a claim. Add information about the product and it tips into promotion, and Edition 20 then requires the inclusions "whether or not the material contains a promotional claim" § 2.1, since the reminder-advertisement exemption is gone.

On the desk

Four checks, in the order a reviewer runs them. Does the piece say review the PI before prescribing, with a route to it? Does the route land on the PI, or on a page where the PI is obvious? Does the funding line describe the product's status accurately for the use the piece promotes — and is it short where the restriction is wider than the PI? And is there a risk beside the benefit on the page itself, or only behind the link? The Reviewer runs the mandatory set as a fixed check on every piece; the pre-review checklist is the same set for the desk.