Topical Non-Prescription Cream — Regulatory Governance & Compliance Framework

Published:

November 4, 2025

1. Purpose & Scope

This framework establishes governance for formulating, manufacturing, labelling, and marketing topical non-prescription creams under Australian law. It ensures compliance with the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, TGA OTC Guidelines, AICIS cosmetics regulations, and ACCC product safety standards.

2. Classification: Cosmetic vs Therapeutic Product

Under the Therapeutic Goods Act 1989, a cosmetic is applied externally for beautifying without therapeutic effect ¹. Therapeutic goods make medical or physiological claims and must be entered on the ARTG ². Misclassification can lead to product seizure and penalties under section 30 of the Act ¹.

3. Ingredient Governance (AICIS vs TGA)

Cosmetic ingredients must appear on the AICIS Inventory ³. Therapeutic actives such as corticosteroids or antibiotics are regulated under the TGA Poisons Standard ⁴. New chemicals require AICIS introduction notification before manufacture or import.

4. Scheduling and Poisons Standard (SUSMP)

The Poisons Standard (SUSMP) classifies actives by risk ⁴. Schedule 2 actives may be pharmacist-only; Schedule 4 substances (e.g., retinoids >0.05%) are prescription-only. Sponsors must verify each ingredient’s scheduling via the TGA Ingredient Database ⁵.

5. Manufacturing Standards (TGA GMP Licensing)

Therapeutic topical creams require TGA GMP-licensed manufacturing ⁶. Cosmetic-only producers are exempt but must maintain traceability and hygiene per AICIS and ACCC standards ⁷.

6. Product Labelling Requirements

Therapeutic labels must meet TGO 92 ⁸; cosmetics must follow ACCC Cosmetic Information Standards ⁷. Labels must show ingredients, batch, expiry, sponsor, and warnings. False or misleading claims breach both the TGA Advertising Code and Australian Consumer Law ⁹.

7. Advertising & Claims

Only ARTG-listed products can make therapeutic claims ⁹. All advertising must comply with the Therapeutic Goods Advertising Code 2021 and be truthful, not misleading, and scientifically substantiated ⁹¹⁰.

8. Packaging, Storage & Shelf-Life

Packaging must ensure stability and prevent contamination. Preservatives must follow the AICIS Cosmetic Ingredient Handbook ³. Shelf-life validation should follow ARGOM Appendix 3 ¹⁰.

9. Safety, Recall & Adverse Event Reporting

Sponsors must maintain pharmacovigilance and report adverse events per TGA guidelines ¹¹. Recalls follow the Uniform Recall Procedure for Therapeutic Goods (URPTG) ¹². Cosmetic recalls follow ACCC Product Safety Guidelines ⁷.

10. Documentation & Ongoing Compliance

Maintain Product Information Dossiers including formulation, stability, and risk data ¹⁰. Review classification annually and ensure all claims, packaging, and advertising meet current laws. Conduct pre-clearance review for marketing materials to ensure compliance with TGA and ACCC requirements.

Sources

Therapeutic Goods Administration (TGA) (2024), Therapeutic Goods Act 1989 (Cth), viewed 04 November 2025, https://www.legislation.gov.au/Series/C2004A03952 ↩
Therapeutic Goods Administration (TGA) (2019), Therapeutic Goods Regulations 1990 (Cth) – Consolidated to 1 October 2025, viewed 04 November 2025, https://www.legislation.gov.au/Series/F1996B00406 ↩
Australian Industrial Chemicals Introduction Scheme (AICIS) (2024), Cosmetics and soap: Personal care, skin-care, make-up and other cosmetic products, viewed 04 November 2025, https://www.industrialchemicals.gov.au/cosmetics-and-soap/personal-care-skincare-make-and-other-cosmetic-products ↩
Therapeutic Goods Administration (TGA) 2024, Poisons Standard (SUSMP), viewed 04 November 2025, https://www.tga.gov.au/how-we-regulate/ingredients-and-scheduling-medicines-and-chemicals/poisons-standard-and-scheduling-medicines-and-chemicals ↩
Therapeutic Goods Administration (TGA) 2025, Ingredient Database and Scheduling Portal, viewed 04 November 2025, https://www.ebs.tga.gov.au/ ↩
Therapeutic Goods Administration (TGA) (2024), Manufacturing principles for therapeutic goods (GMP licensing), viewed 04 November 2025, https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medicine/good-manufacturing-practice-gmp ↩
Australian Competition and Consumer Commission (ACCC) 2024, Cosmetic product safety and labelling, viewed 04 November 2025, https://www.productsafety.gov.au/products/health-lifestyle/cosmetics ↩
Therapeutic Goods Administration (TGA) (2019), Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92), viewed 04 November 2025, https://www.tga.gov.au/resources/legislation/therapeutic-goods-order-no-92-standard-labels-non-prescription-medicines ↩
Therapeutic Goods Administration (TGA) (2021), Therapeutic Goods Advertising Code 2021, viewed 04 November 2025, https://www.tga.gov.au/resources/legislation/therapeutic-goods-therapeutic-goods-advertising-code-instrument-2021 ↩
Therapeutic Goods Administration (TGA) (2025), Australian Regulatory Guidelines for OTC Medicines (ARGOM), viewed 04 November 2025, https://www.tga.gov.au/how-we-regulate/australian-regulatory-guidelines-args/australian-regulatory-guidelines-otc-medicines-argom ↩
Therapeutic Goods Administration (TGA) 2023, Pharmacovigilance responsibilities of medicine sponsors, viewed 04 November 2025, https://www.tga.gov.au/resources/resource/guidance/pharmacovigilance-responsibilities-medicine-sponsors ↩
Therapeutic Goods Administration (TGA) (2024), Uniform Recall Procedure for Therapeutic Goods (URPTG) – Version 2.4 March 2024, viewed 04 November 2025, https://www.tga.gov.au/sites/default/files/2024-03/uniform-recall-procedure-therapeutic-goods-urptg.pdf ↩

Disclaimer for Newcastle Cosmetic Doctor Policies & Procedures

The policies and procedures contained within this document are the exclusive property of Newcastle Cosmetic Doctor and are provided for internal clinical governance and educational purposes only. These materials represent the internal operational framework, safety standards, and evidence-based protocols developed and implemented by Dr. Bart John Scanlon and the Newcastle Cosmetic Doctor team. They are designed specifically for use within Newcastle Cosmetic Doctor and reflect our clinic’s own professional standards, risk assessments, and compliance obligations under Australian law and regulatory authorities. External individuals, practitioners, or organisations must not copy, reproduce, distribute, or rely upon these materials, in whole or in part, for their own clinical, commercial, or educational use without prior written consent from Newcastle Cosmetic Doctor. These materials do not constitute medical, legal, or professional advice and are not intended to be adopted as official protocols or procedures by any other entity. Any external use or adaptation must be independently reviewed and modified to meet the relevant laws, guidelines, and standards applicable to the user’s own jurisdiction, scope of practice, and facility operations. Newcastle Cosmetic Doctor and Dr. Bart Scanlon accept no liability for any loss, injury, or damage arising from the unauthorised use, reliance upon, or misinterpretation of this material.