Guidance

This guidance provides information about preparing Consumer Medicine Information (CMI) documents that comply with current regulations.

Guidance on generic and originator medicines in the context of over-the-counter (OTC) non-prescription medicine applications.

Guidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.

Guidance for industry on how to apply for consent to supply therapeutic goods that do not comply with subsection 9(2) of TGO 92.

Guidance on the format requirements for dossiers.

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

Guidance for holding acceptable evidence to support indications and claims made about your listed medicine.

Guidance about evidence required to substantiate the quality of the product, for over-the-counter (OTC) medicine registration applications.

Guidance on submitting an effective application to register an over-the-counter (OTC) medicine.

Guidance on our approved terminology for medicines.

Guidance about administrative information to support over-the-counter (OTC) medicine applications in Australia.

This guidance describes the safety and efficacy data you will need for CTD Module 4 and Module 5 to support applications to either register an OTC medicine in the ARTG or vary the safety and/or efficacy aspects of a registered OTC medicine. (Formerly ARGOM Appendix 1)

Guidance to assist you with submitting acceptable applications for registration of over-the-counter (OTC) medicines.