Guidance

Guidance on how to interpret Essential Principle 13B and how it applies to your device.

Information that must be submitted in order for an application to list an assessed listed medicine in the Australian Register of Therapeutic Goods (ARTG).

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 complying with therapeutic goods advertising requirements.

Guidance for manufacturers in the development of Technical Master Files (TMF) relevant to blood, blood components and haematopoietic progenitor cells.

Guidance and examples to help you understand the regulatory framework for personalised medical devices.

Guidance about how to advertise therapeutic goods exclusively to health professionals.

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.

Guidance for sponsors or suppliers of biologicals in Australia on their ongoing responsibilities after a product is included on the Australian Register. of Therapeutic Goods (ARTG).

Guidance for sunscreen manufacturers who must comply with the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE009-13).

Guidance on good manufacturing practice (GMP) compliance requirements for domestic and overseas manufacturers of medicines and biologicals.

Guidance explaining regulatory requirements for in-house in-vitro diagnostic medical devices (IVDs).

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

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.

Guidance applies to self-tests and point-of-care combo test kits.

OTC medicine monograph guidance.

Guidance for sponsors, manufacturers and providers of faecal microbiota transplant (FMT) products.

Guidance about how to request reconsideration of 'reviewable' initial decisions by the Minister for Health.

Guidance about the process of applying for a priority determination, which is the first step of the priority review registration pathway.

Guidance for sponsors of faecal microbiota transplant (FMT) products, which are regulated as biologicals.

Guidance to assist Australian corporations seeking to apply for an Australian conformity assessment body (CAB) determination for medical devices (including IVDs) by the TGA.