The pre-review checklist — for promotional material in Australia.

Most of what reviewers send back is not judgment. It is a reference that doesn't say what the claim says, a mandatory statement the template always had until it didn't, a PBS line that changed in April, a piece of risk information sitting a spread away from the efficacy claim it belongs to. A piece goes to medical, regulatory and compliance one reviewer at a time, and each of those finds can send it back, with days lost at every step. All of it is findable before the piece reaches the first reviewer — by the originator, the agency, or the writer — if someone walks the piece the way a reviewer does. This is that walk, as a checklist. Every line carries the clause it rests on, in the Medicines Australia Code of Conduct's own numbering, so anything it asks for can be checked against Edition 20 rather than taken on trust.

How to use it

Run it on the piece as it will ship — the exported PDF, the built page, the final deck — not the working file. Read what is visible, not what you know is meant. Where an item fails, note the clause beside it; that is what a reviewer will cite, and it is what the fix has to answer. And treat the list as a floor: the Code is a principles-based document, and its standard for promotion is one sentence that no checklist exhausts — that information, claims and graphics are "current, accurate, balanced, consistent with the approved product information, and do not mislead directly, by implication, or by omission" § 1.

1. Before you start

• You have the current Australian Product Information for the product open — not the global label, not last year's PI. Every check below runs against it § OP 8.
• You have the current PBS position for the product — listed, restricted, authority required, not listed — as of today, not as of the brief § 2.1(e).
• You know the material class the piece belongs to — HCP promotional, patient aid, disease awareness, consumer media statement, event material — because the required inclusions differ by class. This checklist is written for promotional material directed at healthcare professionals; the consumer media statement set is at the end.
• The references are attached as files, not listed as citations. A reviewer cannot check a citation; they can check a PDF.

2. Every claim, against the PI

• Every indication the piece states or implies is the PI's, in the PI's terms § OP 8.
• Every population — age, line of therapy, severity, prior treatment — is one the PI covers; nothing widens it § OP 8.
• Every dose, regimen and strength matches the PI; nothing rounds, simplifies or extends § OP 8.
• Every endpoint and outcome claimed is one the PI carries, or is substantiated to the standard in section 3 and consistent with the PI § OP 8, § 1.
• Every safety statement — contraindications, precautions, adverse effects, interactions — is the PI's, not softened § OP 8, § 1.1(a).
• Claims about competitor products are held to the same PI standard "irrespective of the source on which the claim is based" § OP 8.
• The piece does not mislead "directly, by implication, or by omission" — read the impression it leaves, not only its sentences § 1.

3. Every claim, substantiated

• Every promotional claim is referenced, and the reference "provide[s] the appropriate level of evidence for the claim being made", reflects "the body of evidence", and lets a reader "independently evaluate the validity of the results" § 1(a).
• The reference says what the claim says — the sentence, the figure, the population, the endpoint. Read the cited page, not the abstract.
• No claim rests solely on a poster, an abstract, a "personal communication" or unpublished data § 1.2(a).
• No safety or efficacy claim rests solely on "data on file" § 1.2(b). Where data on file is used at all, it is available to be supplied on request.
• Where the evidence is a systematic review or meta-analysis, the piece does not select "consistent positive results while neglecting consistent negative results" § 1.2(d).
• Any claim resting on a secondary endpoint in a study whose primary endpoint was not met is consistent with the body of evidence, reflects the study's conclusion, and makes clear the primary endpoint was not met § 1.2(e).
• Post-hoc analyses are identified as post-hoc, used in the context of the primary endpoint, and qualified § 1.2(g).
• Animal or laboratory data do not stand alone, and where used carry a statement that such data "do not necessarily predict clinical effects" § 1.2(i).
• Every comparative claim shows its statistical significance; the accepted level is p < 0.05 § 1.2(j). A non-significant result says so "in full" § 1.2(k); a result with no significance reported says the p value is not available § 1.2(l).
• Comparative claims resting on clinically important differences give the reader enough to judge the significance § 1.2(m).
• No "hanging" comparative — better, stronger, faster, more widely prescribed, than nothing named § 1(h).
• Any superlative is substantiated by evidence of the level a superlative needs § 1(f).
• Qualifying statements sit directly below or adjacent to the claim they qualify, linked by a readily identifiable symbol, and are prominent § 1(b).
• Any clinical benefit claimed is "of a magnitude that is generally accepted as clinically meaningful" § 1(d).
• Any healthcare professional's name, image or quotation has their documented approval on file § 1(g).
• The substantiation file can be produced within ten working days of a request § 1(i).

4. Balance

• For each efficacy claim, risk information is present with comparable prominence, placement and extent — "proportionate weight to the benefits and risks" § 1.1(b).
• Product and risk information are treated "as relevant as any therapeutic, promotional, or non-promotional claim" — not relegated to the back page in six-point type § 1.1(b).
• The depth of the risk presentation suits "the complexity of the promotional material, the therapy area, stage of product lifecycle" — a survival-curve piece carries more than a reminder item § 1.1(c).
• Adverse-event data get the same visual treatment as efficacy data — the same chart type, the same scale, the same emphasis.
• The piece supports "appropriate use consistent with the Product Information" rather than use beyond it § 1.1(a).

5. The seven mandatory inclusions

§ 2.1 applies to "all promotional material for a product, whether or not the material contains a promotional claim" — so a brand-and-logo placement runs this list too.

• (a) The brand name of the product.
• (b) The Australian Approved Name(s) of the active ingredient(s), "placed adjacent to the most prominent presentation of the brand name" — beside the biggest brand mark, not in the footer.
• (c) Any boxed warning and/or black triangle statement the TGA requires, worded as the PI has it.
• (d) A statement directing healthcare professionals to review the PI before prescribing, with "the means for healthcare professionals to access the PI immediately in electronic or other form" — a URL, a QR code — "or the telephone number for the Company medical information service".
• (e) A statement of the product's public funding or reimbursement status, with or without listing details, "or a direction to where the relevant information is available" — and it matches today's PBS position.
• (f) The name of the supplier and "the city, town or locality of the registered office" — both; the name alone does not satisfy the clause.
• (g) The date the material "was prepared or last revised" — and it is this version's date.

Not on the list, and not a § 2.1 failure if absent: a job or approval code. Print one anyway; it is how the withdrawn version gets found.

6. Presentation

• The promotional material is "clearly distinguishable as such" — nothing dressed as editorial or education § 2(b).
• PI statements, qualifying statements and references are "clearly legible" § 2(d) — at the size they will print or render, on the device they will be read on.
• Everything visible on its own — the first page, the fold, the first slide, the banner before the click — is "accurate and consistent with the Code when read in isolation" § 2(e).
• Graphics carry the same standard as text: charts are not truncated, scaled or coloured to overstate § 1.
• Where the piece links to material the company did not develop, the reader is told before they leave, in the Code's words: "The information a reader is about to be referred to may not comply with the Australian regulatory requirements…" § 2.2(c).

7. Audience and channel

• The material can be "viewed or accessed" only by healthcare professionals § 2(a).
• Online, that restriction is real — "a mechanism such as password protection for system entry" § 2.2(a).
• On social media, content the public can see carries no promotional claims for a prescription product, and content with claims is "restricted to a verified healthcare professional audience" § 10.2(a), § 10.2(b).
• Nothing promotional sits in prescribing software where a patient could see it during a consultation § 2.3(a).
• If the piece is for patients, it goes "only to patients already prescribed the product and must not be promotional"; items used outside the home carry a company name and logo only § 12(d).
• If the piece is a CMI or PI made available to the public, it is "in [its] entire form" and "not amended, abridged or displayed in a promotional manner" § 12(a).

8. The paperwork

• The references are attached, in full, in the version the claim cites.
• Every "data on file" reference exists as a document someone can hand over § 1.2(b), § 1(i).
• Every healthcare professional approval is on file before the piece leaves § 1(g).
• The PI version and the PBS position the piece was checked against are recorded with the approval — so the next reviewer knows what "current" meant on the day.
• The final signatory has signed the version that ships, not the one before the agency's last change.

9. After sign-off — the re-review triggers

A piece that passed in March can be non-compliant in June with nothing on the page altered. Bring it back when:

• The PI changes — a new indication, a narrowed population, a new contraindication or boxed warning. Items (c) and (d) above, and every claim in section 2, are live again § OP 8, § 2.1(c), § 2.1(d).
• The PBS position changes — a listing, a restriction, a delisting. Item (e) is live again § 2.1(e).
• New evidence lands that changes the body of evidence a claim rests on § 1.2(c).
• A complaint names the piece, or a competitor's piece in the same category is found in breach — read yours the way their medical director would.
• The piece is adapted — a new channel, a new format, a translation. The walk starts again from section 1; the seven inclusions do not carry across by themselves.

For a product-specific consumer media statement

A different set applies. A media statement to consumer media may be issued in the circumstances § 10.1(b) names — a new product or indication registration, new or changed public funding, or, in consultation with the TGA, safety, shortage, recall or withdrawal — once per circumstance § 10.1(c), and not before the product or indication is registered and healthcare professionals have been told § 10.1(d). It "must contain all of the following" § 10.1(e):

• (i) the product's brand name;
• (ii) the Australian Approved Name of the active ingredients;
• (iii) its approved indications, relevant to the statement;
• (iv) therapeutic class;
• (v) public funding status and restrictions, or a notation if the product is not publicly funded;
• (vi) a summary of the side effect profile, precautions, adverse effects, warnings, contraindications and interactions; and
• (vii) a copy of, or a link to, the Consumer Medicine Information.

It may also carry a non-comparative description of the mechanism of action, the price to the patient, and the date of availability § 10.1(f). It must not carry promotional statements or claims, comparisons with other products, promotional or comparative quotes from experts or patients, an image of the packaging, or a reference to a product access program, and must not be accompanied by anything designed to encourage use of a prescription product § 10.1(g).

What this list is not

It is not the Code, and where the two disagree the Code wins — the full text is a click away in the sources. It does not replace your reviewers: a piece can tick every line and still leave the wrong impression, which is what they are there to judge. And it does not cover events, hospitality, grants, patient support programs or transparency reporting, each of which has its own sections. What it does is take the find-the-error work off each reviewer's desk, so every step can be about judgment.