Guidance

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 for hand sanitiser manufacturers, suppliers and advertisers about meeting their regulatory obligations.

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.

Guidance for manufacturers of medical or surgical face masks and respirators on the standards and key performance aspects required for inclusion on the Australian Register of Therapeutic Goods (ARTG).

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

Information to assist sponsors and manufacturers of products making antiviral claims determine if their product require an entry in the Australian Register of Therapeutic Goods (ARTG) to be legally imported and/or supplied in Australia.

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 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.

Guidance on how to meet child-resistant packaging requirements in the Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95).

Guidance explaining how to find out which statements (if any) are required by the RASML for a particular over-the-counter (OTC) or complementary medicine.