Guidance

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

The requirements for an effective OTC medicines application commences 1 March 2016.

Administrative information to support OTC medicine applications in Australia

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 3.

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

Guidance on the format requirements for dossiers. Amendments to Part C to update the reference for dossier requirements for biologicals.

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 on our approved terminology for medicines.

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

Guidance explaining types of variations, for registered medicines and biologicals, that can be submitted as notifications due to being very low risk.

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).

OTC medicine monograph guidance: Topical nasal decongestants.

OTC medicine monograph guidance: Bromhexine hydrochloride.

This OTC Medicine Monograph guidance outlines requirements for Australian market authorisation of oral medicines containing ranitidine hydrochloride as a single active ingredient when applied for as an OTC New Medicine N2 application.

OTC medicine monograph: Topical imidazole antifungals for dermal use - clotrimazole and miconazole nitrate.

Guidance on the market authorisation requirements for over-the-counter (OTC) New Medicine N2 applications for new products that contain aspirin as a single active ingredient.

OTC medicine monograph guidance: paracetamol for oral use.

This OTC medicine monograph outlines the requirements for Australian market authorisation of oral medicines containing loperamide hydrochloride as a single active ingredient when applied for as an OTC New Medicine N2 application.

OTC medicine monograph guidance: Laxatives: Docusate sodium and/or sennosides.

This OTC Medicine Monograph outlines the requirements for Australian market authorisation of a cough expectorant containing guaifenesin as a single active ingredient when applied for as an OTC new medicine N2 application.

OTC medicine monograph guidance.

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).