Rejuran Advertising Rules vs Profhilo Advertising Australia
In the world of non-surgical cosmetic procedures, terms like “Rejuran” and “Profhilo” have become household names among aesthetic clinics and patients alike. But for registered health practitioners in Australia, understanding what you can and cannot say in your marketing is critical — especially when it comes to differentiating between medical devices and prescription-only medicines.
In this post, we break down the TGA and AHPRA advertising rules, explain how product classification affects compliance, and help your clinic avoid costly missteps.
Understanding TGA Schedule 4 Advertising and ARTG Classification for Injectables
At the core of compliant advertising is understanding how a product is regulated in Australia.
Rejuran – A Class III Medical Device
Rejuran is listed on the Australian Register of Therapeutic Goods (ARTG ID: 412630) as a Class III medical device. Its key ingredient is polynucleotides (PDRN), derived from purified salmon DNA. Despite its biological origin, Rejuran is not listed under any schedule in the Poisons Standard, and is not classified as a medicine.
Because of this classification:
✅ It is legal to advertise Rejuran publicly, provided all claims comply with TGA’s advertising code and AHPRA guidelines.
❌ You cannot make unsubstantiated therapeutic claims (e.g. “heals skin” or “repairs DNA”).
✅ Descriptive, non-therapeutic phrases such as “supports skin rejuvenation” or “contains polynucleotides” may be acceptable with caution.
Important: Even though Rejuran can be advertised, all statements must still be evidence-based, non-misleading, and avoid exaggeration or glamorised outcomes.
Profhilo – A Prescription-Only Hyaluronic Acid Injectable
Profhilo, on the other hand, contains hyaluronic acid (HA) — a substance listed under Schedule 4 (S4) of the Poisons Standard. Despite being ARTG-listed as a Class III medical device, the presence of a Schedule 4 ingredient overrides its classification in terms of advertising.
This means:
❌ You cannot advertise Profhilo by name to the public.
❌ You cannot refer to “hyaluronic acid injectables” in a promotional way.
✅ Profhilo may be discussed only in private consultations under the direction of a prescriber.
Attempting to advertise Profhilo publicly — including indirect references like “HA injectables that hydrate from within” — is a breach of Section 42DL(1)(f) of the Therapeutic Goods Act 1989 and may result in enforcement action.
AHPRA Advertising Guidelines and Cosmetic Clinic Compliance
Know the Difference Before You Write
Here’s a simple breakdown:
| Product | Classification | Schedule Status | Public Advertising Allowed? |
|---|---|---|---|
| Rejuran | Class III Medical Device | Not Scheduled | ✅ Yes (with limitations) |
| Profhilo | Class III Medical Device | Schedule 4 (S4) | ❌ No |
If a product is a prescription medicine, it is off-limits for advertising — regardless of whether it is listed on the ARTG or not. Even referencing the product’s effects (e.g. “improves skin elasticity”) may be a breach if it’s implied to relate to a Schedule 4 product.
Key Takeaways for Clinics and Cosmetic Providers
1. Medical Device vs Prescription Medicine in Cosmetic Injectables
Before promoting any brand name, check whether it is:
Listed on the ARTG
Categorised as a medical device or medicine
Contains ingredients scheduled under the Poisons Standard
Use the TGA’s online ARTG database to verify product status.
2. Injectables Advertising Australia: What You Can and Can’t Say
Statements like “hydrating skin boosters” or “HA-based injectables” may still breach TGA guidelines if they indirectly promote a Schedule 4 product like Profhilo or Botox.
When in doubt: if it requires a prescription, don’t advertise it.
3.Avoiding Breaches of the Therapeutic Goods Advertising Code
Just because a product is ARTG-listed as a Class III device doesn’t automatically mean it’s safe to advertise. The active ingredient’s scheduling is what determines advertising permissibility — not just the device classification.
This distinction is crucial and commonly misunderstood.
4. Understanding Prescription Medicine Promotion Restrictions
For products like Rejuran, you may mention the brand, but consider including a disclaimer such as:
Rejuran is a Class III medical device registered with the TGA (ARTG ID: 412630). It is not a prescription-only medicine, but is used in professional settings only. Always consult a qualified practitioner.
This demonstrates transparency and helps prevent accusations of misleading advertising.
Final Word – When in Doubt, Leave It Out
Australian cosmetic advertising regulations are among the strictest in the world. If you’re unsure about a claim, product name, or phrase, err on the side of caution. Breaching the advertising rules can lead to warnings, deregistration, or court action under the National Law and the Therapeutic Goods Act 1989.