Guidance

Understand the regulatory requirements for supplying UDI compliant medical devices in Australia

Timeframes for supplying UDI compliant medical devices in Australia

This Guidance describe the requirements and standards for sunscreens (and their ingredients), that we regulate as therapeutic goods in Australia

Guidance to help sponsors understand the potential overlap between certain foods, medicines, devices and cosmetics.

Guidance to assist sponsors and manufacturers comply with Therapeutic Goods (Microbiological standards for medicines) (TGO 100) Order 2018.

Australian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 4.

Australian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 3.

This guidance is to assist you to apply for a Certificate of Free Sale or an Export Certificate for medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs).

This guidance is to assist entities and individuals planning to export medicines (including prescription, over-the-counter (OTC) and complementary medicines) either for commercial supply, or for non-commercial purposes (for example, for a family member or friend).

Guidance to change an ARTG registered over-the-counter (OTC) medicine.

Guidance for industry organisations applying to add a medicine to the Australian Register of Therapeutic Goods (ARTG).

Guidance about application pathways and data requirements for new generic medicines, and variations to existing medicines.

This guidance will help you understand our pharmacovigilance inspection program (PVIP).

This guidance explains requirements for registering a non-prescription over-the-counter (OTC) medicine on the Australian Register of Therapeutic Goods (ARTG).

Guidance on requirements for Australian market authorisation of preparations containing bromhexine hydrochloride, for an OTC new medicine N2 application.

Guidance on requirements for Australian market authorisation of topical nasal decongestant medicines, for an OTC new medicine N2 application.

Guidance on requirements for Australian market authorisation of tablets containing aspirin, for an OTC new medicine N2 application.

Guidance on requirements for Australian market authorisation of topical imidazole antifungal medicines for dermal use, containing clotrimazole or miconazole nitrate, for an OTC New Medicine N2 application.

Guidance on requirements for Australian market authorisation of oral medicines containing ranitidine hydrochloride, for an OTC new medicine N2 application.

Guidance on requirements for Australian market authorisation of oral medicines containing paracetamol, for an OTC New Medicine N2 application.

Guidance on requirements for Australian market authorisation of oral medicines containing loperamide hydrochloride, for an OTC New Medicine N2 application.

Guidance on requirements for Australian market authorisation of oral laxative medicines containing docusate sodium and/or sennosides, for an OTC new medicine N2 application.

Guidance on specific criteria and paperwork required for submission to the TGA to ensure conformance with TGO 93.

Guidance on requirements for Australian market authorisation of oral preparations containing dextromethorphan hydrobromide, for an OTC new medicine N2 application.

Guidance on requirements for Australian market authorisation of a cough expectorant containing guaifenesin, for an OTC new medicine N2 application.