Journal · Updated 29 August 2026 · 7 min read
Edition 20 — what changed, and what to do about it.
The Medicines Australia Code of Conduct's Edition 20 has been in effect since 30 March 2025. What actually moved for the people who review, file and defend promotional material — the retired Minimum PI, the inclusions that now apply to every piece, the complaints gateway, the renumbered sections that stale SOPs still cite — and the six things to do about it.
Edition 20 of the Medicines Australia Code of Conduct was adopted at the association's annual general meeting on 30 October 2024 and took effect on 30 March 2025. Eighteen months on, most affiliates have updated the front of their SOPs and few have updated the citations inside them. This is a working list of what actually moved — for the people who review material, file transparency reports and answer complaints — sourced to the Code's text and to the Tool Kit guidance Medicines Australia published alongside it, with the things that did not change named too, because those are where the stale citations hide.
The shape of it
Edition 20 is a restructure, not an amendment. The Code now runs in six parts — A, the ten Overarching Principles; B, interactions with healthcare professionals (Sections 1–9); C, relevant stakeholders (10–11); D, patients and the public (12–13); E, transparency (14); F, governance (15–17) — with the operational detail moved out of the Code and into the Code Tool Kit, which is now where the templates, the hospitality cap and the complaints procedure live. Two consequences follow. Section numbers moved, so anything that cites Edition 19 by number is probably wrong now. And the Code is "systems neutral": promotional content is governed by what it does, not the medium that carries it — print, digital, social and whatever comes next fall under the same Principles and the same Sections 1 and 2.
The three to internalise first
1. The Minimum Product Information is no longer a required inclusion. Edition 19's Section 2.2 described the Min PI and required it in print and digital promotional material. Edition 20 replaces the mandate with § 2.1(d): "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". The Tool Kit's Prescribing Information Guidance (March 2025) is explicit that the Min PI is not required in any form of promotional material under Edition 20, and that companies may still use one voluntarily as a summary. It also notes that the PI-access statement, while common practice, "was not an explicit requirement in Code Edition 19" — so check existing materials for the access language, and add it where it's missing.
2. The inclusions apply to every piece, claim or no claim. § 2.1 opens: "All promotional material for a product, whether or not the material contains a promotional claim, must include or provide access to sufficient prescribing information". Edition 19 recognised a "reminder advertisement" — brand and logo, no therapeutic claim — as a category exempt from the Min PI. Edition 20 does not preserve the exemption. A journal placement of brand and logo carries the seven § 2.1(a)–(g) inclusions: brand name, Australian Approved Name beside the most prominent brand mark, boxed warning or black triangle where the TGA requires one, the PI-access statement, public funding status, supplier name and locality, and the date prepared.
3. Intercompany dialogue is the gateway to a complaint. Company-initiated complaints now go through the Intercompany Dialogue Standards in the Tool Kit, and Medicines Australia "will not accept a complaint from a Company unless it has been clearly demonstrated that intercompany dialogue has taken place and the complaint has not been resolved" § 15.1(c). Edition 20 also added § 15.5: either party may allege the other failed to follow the Standards, and the schedule of fines in § 15.6 carries a line for it — "Failure to follow Intercompany Dialogue Standards, $100,000". The Tool Kit's Industry Complaints Process (revised October 2025) sets out the mechanics: a formal written complaint, response and meeting windows measured in working days, and a Managing Director or Medical Director signature before Medicines Australia will accept it.
Renumbered — the citations to fix
These are the Edition 19 numbers most often still found in SOPs, training decks and template footers, and where the concept now lives.
| If your document says | Edition 20 says | Note |
|---|---|---|
| "Section 2.2" for the Min PI | Retired. The PI-access statement is § 2.1(d) | The Min PI is optional; the access statement is mandatory |
| "Section 8" for scientific exchange | § 7 | The Tool Kit's Virtual Meetings Guidance points readers to "Section 8 of Edition 19 as a guide" for what is now Section 7 |
| "Section 13" for the prohibition on promoting to the public | § 13 is Patient Support Programs. The prohibition is statutory — the Therapeutic Goods Act — and carried in the Code by § 10.1(a), § 10.2(a) and § 12 | There is no "Section 13(a) DTC prohibition" in Edition 20 |
| "Section 16" for sanctions | § 15.6 | § 16 is the committees — their membership, appointment and terms |
| "Section 17" for transfer-of-value reporting | § 14.1 | § 17 is Code of Conduct Reporting; transparency is the whole of § 14 |
The rule of thumb: identify the concept, then find it in Edition 20's contents page. Never carry a number across.
Retired, moved or narrowed
The hospitality cap left the Code. The per-head figure that used to sit in the Code's text is now in the Tool Kit: § 4.5(c) refers to "a capped maximum spend per person… This amount is outlined in the Code Tool Kit." The Hospitality and Venues Guidance (revised March 2025) sets it at AUD $140 per person per meal, excluding gratuities and GST. Cite the Tool Kit for the number, not the Code — and expect the number to move without a new edition.
"Reminder advertisement" is gone as a category — see the second point above. The piece still exists; the exemption doesn't.
Balance has its own clause and a definition. § 1.1 sets out the requirement — "proportionate weight to the benefits and risks of a product" — and the Glossary defines balance in one line. The media release describes this as a more concise definition to guide companies; in practice it gives reviewers a clause to cite where Edition 19 left them citing the general standard.
New
Section 15.5 and the Intercompany Dialogue Standards — covered above; the Standards are binding through § 15.1(c), and a $100,000 fine attaches to not following them.
Two-way communication in scientific exchange. The lead-in to § 7 now states that scientific exchange "must be for the purposes of enhancing scientific understanding… The intent of such activities must be non-promotional with a focus on exchange being two-way communication." The Tool Kit's Scientific Exchange FAQs (March 2025) treat this as a requirement to be met: a one-way presentation to healthcare professionals, without a genuine opportunity for exchange, does not satisfy Section 7.
Disclosure Australia, by name. § 14.1(h) names the central reporting system for transfers of value to healthcare professionals — "Disclosure Australia, which will be searchable and downloadable in a format compatible with database management systems" — and § 14.2 and § 14.4 fix the calendar around it. Grants and donations to healthcare organisations are inside the transparency reporting framework § 14(a), § 14.2; the launch release names their inclusion as one of the edition's changes.
Consumer media, strengthened. The launch release names "strengthened guidance on ethical and responsible product-related statements to consumer media, including social media" among the changes. In the Code that is § 10.1 — the circumstances in which a product-specific media statement may be issued, the seven things it must contain, and what it must not — and § 10.2 on social media, which treats it "in the same way as more traditional media activities".
What did not change
For completeness — because a reviewer who knows these carry over will not go looking for a renumbering that isn't there:
- The Overarching Principles: ten, no sub-structure.
- The § 4.5 hospitality mechanics — no entertainment, no private homes, no companions or family — even though the dollar cap moved.
- The substantiation carve-outs in § 1.2: posters, abstracts and personal communications not sole substantiation; data on file not sole substantiation for safety or efficacy; no selective use of positive results.
- The transparency cadence and the three-year publication window § 14(d).
- The Working Together Guide as the reference for patient-organisation engagement § 11(a).
Six things to do
- Search your materials for the PI-access statement. It's the one thing Edition 20 made explicit that Edition 19 didn't. Add it where it's missing; the Min PI can stay if it's accurate, but it no longer carries the obligation § 2.1(d).
- Pull your reminder ads. Anything brand-and-logo in market now needs the seven inclusions § 2.1.
- Find-and-replace the section numbers in SOPs, training, template footers and approval checklists — Section 8, 13, 16 and 17 in particular, per the table above.
- Move the hospitality cap out of your policy text and into a reference to the Tool Kit, and check the current figure there before every event § 4.5(c).
- Rewrite the complaints SOP around intercompany dialogue: the Standards, the windows, the signatory § 15.1(c), § 15.5.
- Re-read your scientific exchange formats against "two-way communication" § 7 — a webinar with a Q&A box is a different thing from a presentation.
Everything here is the Code as it stands today. When Edition 21 is adopted, this post becomes the historical half of a new one.