Australian regulatory guidelines for OTC medicines (ARGOM)

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,689kb)*

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,128kb)
• Chapter 11 - Changes to OTC Medicines (pdf,125kb)

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. Please note: this document is only available in hardcopy as a double-sided black & white print on plain A4 paper. It does not come with a folder and is not bound in any way.

• Australian price (GST inclusive): $100.00
• Overseas price (+ Airmail): $90.90 (+$25.00)

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