Australian regulatory guidelines for OTC medicines (ARGOM)
Review of the Australian Regulatory Guidelines for Over-The-Counter Medicines
Aims and approach
The TGA has begun a project which will review and amend the current Australian Regulatory Guidelines for Over-The-Counter Medicines (ARGOM), published in 2003. This project will bring the ARGOM up to date to reflect the current TGA regulatory environment and business practices for Over-The-Counter (OTC) Medicines. The project is called ARGOM-09.
The ARGOM 2003 is being updated to:
- ensure that the guidelines reflect current legislative regulatory requirements;
- streamline processes where possible;
- improve the usability and consistency of the information available to stakeholders in relation to the Australian regulatory requirements for OTC medicines;
- provide increased transparency about decision making processes; and
- clarify post market monitoring of OTC medicines.
It is anticipated that, during the ARGOM update process, the TGA will initiate additional longer-term projects to consider particular aspects of the current regulatory requirements and business processes related to OTC medicine regulation. An example of one such project will be the development of a new guideline for OTC antiseptic and skin disinfectant products.
The updated ARGOM will be drafted in liaison with industry stakeholders. The TGA will work with the Australian Self-Medication Industry (ASMI), the Generic Medicines Industry Association (GMiA), the Australian Association of Cosmetic Chemists (ASCC), and the Advocate for the Consumer, Cosmetic, hygiene and specialty products sector (ACCORD). Each new draft of an ARGOM chapter will be published on this website to enable broader public consultation.
ARGOM, 2003 will remain as the guidance document until it can be fully replaced by the updated ARGOM (2009).
Project duration
Re-drafting and consultation of the ARGOM will occur from October 2008 onwards. It is intended that the public consultation of the revised ARGOM will commence in early 2010, and publication will occur during 2010.
Contact for further information
Comments regarding the ARGOM-09 project may be sent by email (preferred) or by post, and should include your full contact details.
ARGOM-09 Project Manager: Dr Vanessa Burgess
Email: vanessa.burgess@tga.gov.au
Telephone: 02 6232 8621
Dr. Vanessa Burgess
OTC Medicines Section
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Australia
ARGOM
These Guidelines describe the information to be supplied with an application for registration of OTC (over-the-counter) medicines in the Australian Register of Therapeutic Goods (ARTG). These medicines will be subject to evaluation by the Non-prescription Medicines Branch of the Therapeutic Goods Administration, in accordance with Section 25 of the Therapeutic Goods Act 1989.
This information will enable the determination of the application for registration and, accordingly, the Guidelines are approved for the purposes of subsection 23(2) of the Therapeutic Goods Act 1989 with effect from 1 July 2003.
The Guidelines also give guidance on the information required to be submitted for consideration of applications to vary information about therapeutic goods included in the Register, which are made under subsection 9D(1), (2) or (3) of the Therapeutic Goods Act 1989.
Complete ARGOM document
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Australian regulatory guidelines for OTC medicines (complete document) (pdf,691kb)
Individual sections of ARGOM
- Foreword, contents, Chapter 1 - Introduction (pdf,87kb)
- Chapter 2 - Overview (pdf,74kb)
- Chapter 3 - The application (pdf,80kb)
- Chapter 4 - Quality, 4A Manufacture, 4B Formulation, 4C Starting material specifications, 4D Finished product specifications, 4E Stability testing, 4F Microbiological testing (pdf,220kb)
- Also see: Colourings permitted in medicines for oral use <http://www.tga.gov.au/meds/colourings.htm>
- Chapter 5 - Presentation, 5A Product name, 5B Labelling, 5C Product information (PI), 5D Consumer Medicine Information (CMI), 5E Changes to scheduling (pdf,128kb)
- Chapter 6A Efficacy and safety, 6B New substances (pdf,108kb)
- Chapter 7 - Review of decisions, Chapter 8 - Post marketing surveillance (pdf,61kb)
- Chapter 9 - MEC guidelines (pdf,185kb)
- Chapter 10 - Sunscreens (pdf,121kb)
- Chapter 11 - Changes to OTC Medicines (pdf,134kb)
Hardcopies of ARGOM
If you require this document in hardcopy please complete a publications order form <http://www.tga.gov.au/pubs/puborder.htm>. Payment must accompany the order.
- Australian price (GST inclusive): $100.00
- Overseas price (+ Airmail): $90.90 (+$25.00)