All medicinal products, prescription, OTC (over the counter) or complementary must be entered on the Australian Register of Therapeutic Goods (ARTG) before supply may commence.
Advantage Medical Products Consulting can assist you to quickly establish the specific requirements for your product. We can provide a complete application service, ensuring all your data meets the relevant guidelines, lodge applications and liaise with the TGA throughout the evaluation process, allowing you to focus on your core business.
The TGA will not accept your application if your overseas manufacturer does not meet Australia’s Standard of Good Manufacturing Practice. If you consider your manufacturer to meet this standard, please email a copy of your GMP certificate and we can quickly tell you if it satisfies TGA requirements.
If your manufacturer cannot provide suitable evidence of GMP, the products can not be supplied in Australia.
Other requirements include:
- All products to be entered on the ARTG must have a sponsor in Australia
- The labels must be in English and meet Australia’s standard for medicines labelling
- For prescription medicines, data must be available for evaluation which satisfies the TGA prescription medicine guidelines. Australia also requires administrative and prescribing information.
- For over the counter (OTC) medicines, data must be available for evaluation which satisfies the TGA OTC medicine guidelines.
- Complementary medicines may be registered (higher risk) or listed (lower risk)
- For registered complementary medicines, data must be available for evaluation which satisfies the TGA complementary medicine guidelines
- Listed complementary medicines are entered directly on the ARTG using the online electronic lodgement facility (ELF). All ingredients must be eligible for listed medicines and labels must be in English and meet Australia’s standards.
New Zealand Requirements
All prescription and OTC medicines require prior approval from MEDSAFE before supply in New Zealand. New medicines and related product applications and changed medicines and related product notifications can be prepared and lodged with MEDSAFE.
New Zealand is in a time of transition for complementary medicines currently regulated as dietary supplements without claims. The Dietary Supplements Database is being used to collect information about complementary medicines on the New Zealand market.