TG: ARTG? (8)

The first thing you should do is search the Australian Register of Therapeutic Goods (ARTG) for the product you want to supply.

Searching the ARTG

In most cases, therapeutic goods must be entered in the ARTG before they can be lawfully supplied in or exported from Australia. 

We enter therapeutic goods in the ARTG when:

• higher risk therapeutic goods have been assessed as meeting the requirements for quality, safety and, where appropriate, efficacy and/or performance; or
• lower risk therapeutic good applications have been validated.

For medicines and biologicals, each separate and distinct product will usually have its own ARTG entry. The Therapeutic Goods Act 1989 describes when products are considered separate and distinct (for example, different dosage, formulation and indications).

For medical devices, each kind of device will have its own ARTG entry.

If your product is not in the ARTG, you will need to apply to become a sponsor and have your product entered in the ARTG.  

Products already in the ARTG

If your product is in the ARTG, we have already authorised it for supply for another sponsor. You can apply to become a sponsor yourself and have your product entered in the ARTG under a different product name, or contact the sponsor of the ARTG entry to find out if you can become a wholesaler or retailer.