Regulation of antibacterial hand washes
Question: I would like to import an antibacterial hand wash to sell in Australia. What regulations do I have to meet in order to do this?
Antibacterial hand washes are currently regulated as medicines by the TGA. However, one of the recommendations in the report Regulation of Cosmetic Chemicals: Final Report and Recommendations, published in November 2005 and available on the NICNAS website is that antibacterial skin washes be regulated as cosmetics.
Pending legislative underpinning of these recommendations, interim arrangements are in operation under NICNAS, the cosmetics regulator. This means that businesses introducing an antibacterial skin wash can choose to either remain regulated as a medicine by the TGA or apply to NICNAS under interim arrangements to have the product regulated as a cosmetic. This provision is available for antibacterial skin products other than those used for:
- Prevention of the transmission of disease; or
- Specifically for use in clinical/surgical settings.
Forms and guidance on interim arrangements, including further explanation of these exclusion criteria, are available on the NICNAS website <http://www.nicnas.gov.au>.