Supply a non-prescription medicine
Information on how to supply a non-prescription medicine.
Non-prescription medicines are comprised of complementary medicines and over-the-counter medicines, including sunscreens.
There are the following types of non-prescription medicines:
- listed medicines
- assessed listed medicines
- registered complementary medicines
- over-the-counter (OTC) medicines.
These are categorised on the ingredients they contain and therapeutic indications (claimed health benefits) they use.
- An overview of the regulation of complementary medicines in Australia
- Pathways to evaluating your medicine
- Changes to nappy rash products
- Submitting data in the eCTD format
- Submitting data in the NeeS format
- Pathways for complementary medicine products
Inhalation and nasal sprays
Listed and registered medicines
- Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines
- Notifications process: registered medicines
- Listed complementary medicines
- What do I require to have a listed medicine in the ARTG?
- Information on our proposed updated evidence guidelines for listed medicines
- Information on our proposed updated evidence guidelines for listed medicines - 28 March
- Webinar presentation: Information session on the revised evidence guidelines for listed medicines, 23 March 2022
- Mandatory requirements for an effective registered complementary medicine application
- Overview of the regulation of listed medicines and registered complementary medicines
Assessed listed medicines
- Assessed listed medicines
- Assessed listed medicines pathway for complementary medicines
- Assessed listed medicines pathway: frequently asked questions
- Australian Regulatory Guidelines for OTC medicines (ARGOM)
- OTC new medicines registration process
- Process to change a registered OTC medicine
- Approved manner of making an application under section 23 of the Therapeutic Goods Act 1989 for a registered OTC medicine
- ARGOM Appendix 2: Guidelines on quality aspects of OTC applications
- Requirements for OTC new medicines N2 applications (using OTC medicine monographs)
- Mandatory requirements for an effective over-the-counter medicines application
- NewsThe Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open until 18 December 2022 for medicine sponsors to complete.
- Media releasesThe TGA has issued two infringement notices totalling $5,328 to a Queensland-based individual for the alleged unlawful use of a prohibited representation and endorsement in advertising a listed complementary medicine.
- NewsTell us your experience using of the beta Database of Adverse Event Notifications (DAEN) - medicines.