You are here
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.
- ServiceOutline of the process for entering your non-prescription medicine onto the Australian Register of Therapeutic Goods.
- 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
- GuidanceThese guidelines provide details and guidance on the clinical evidence requirements for medical devices, including In Vitro Diagnostic medical devices (IVDs), under Australian legislation.
- Safety alertsRead our safety advisory for Medicines containing Withania somnifera (Withania, Ashwagandha). Be aware of potential gastrointestinal symptoms and very rare cases of liver injury.
- Product recallsThere have been reports of the dose counter stopping after the 10th dose and not locking after the 60th dose. If this happens, you should return the product to your place of purchase or contact Boehringer Ingelheim.
- Media releasesThe TGA has issued 2 infringement notices totalling $37,560 to Queensland-based company Akula Foods Pty Ltd for the alleged unlawful import of unregistered complementary medicines
- Liquefy Health Pty Ltd fined for allegedly importing and advertising unapproved complementary medicinesMedia releasesThe TGA has issued 4 infringement notices totalling $75,120 to Liquefy Health Pty Ltd for the alleged unlawful importation and advertising of unapproved complementary medicines.
- NoticesAnnouncement about the launch of the pilot Single Inspection Program, a global approach to Good Manufacturing Practice inspections of third country manufacturers.
- Closes onConsultationWe are seeking feedback on whether certain international scientific guidelines should be adopted.
- Closed onConsultationThe TGA is seeking feedback on proposed clarification and updates to the regulation of sunscreens. Closing date: 31 May 2023