How tampons are regulated in Australia
Tampons are therapeutic goods that are exempt from the requirement to be entered on the Australian Register of Therapeutic Goods (ARTG) before being supplied in Australia.
Prior to 1 July 2018, tampons were required to be listed on the ARTG in order to be able to be legally supplied. As a result of recent regulatory amendments, these products became exempt goods and therefore you are no longer required to have ARTG entry for these products.
For sponsors and applicants
To reflect this regulatory amendment, you may need to do the following:
- Existing ARTG entries
- Sponsors with existing ARTG entries for tampons can contact the TGA and request cancellation of their listed ARTG entries for these products. The TGA will notify you when your ARTG entry is cancelled.
- If you decide to maintain ARTG listing for these products, you will continue be responsible for paying all respective future annual charges.
- Current applications
- You no longer require ARTG listing for tampons, and therefore you may decide to withdraw your application. If you choose to do so, you will be free from paying any future fees or charges. You should know, however, that there is no provision for us to refund the fees you have already paid.
- If you decide to continue with your application, the TGA will follow the normal assessment process, and you will be obliged to pay all respective fees and charges (as applicable).
Guidance on the regulation of tampons in Australia
Even though tampons are no longer required to have ARTG entry before being supplied in Australia, they must still meet the requirements under AS 2869:2008 Tampons - Menstrual.
For guidance on the regulatory requirements stated in the Standard, please see:
If you experience an adverse event with a tampon, please tell us about it: Medical device adverse event reporting by medical device users.