Guidance

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

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

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

Guidance on TGO 107: Mandatory labelling requirements for biologicals and human cell and tissue materials.

Guidance to explain how the intended use of a biological product influences its classification and exemptions.

Guidance on the legislative, regulatory and good clinical practice requirements when conducting clinical trials in Australia using unapproved therapeutic goods.

Guidance about the regulation of sport supplements in Australia for importers and sellers.

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

Guidance on medical device application processing timeframes.

Guidance about how we regulate biologicals that are packaged, or combined, with other therapeutic goods.

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

This guidance helps sponsors and manufacturers of ‘unapproved’ therapeutic vapes understand quality and safety requirements, under the Therapeutic Goods (Medical Device Standard —Therapeutic Vaping Devices) Amendment Order 2024.

Guidance on the quality and labelling requirements of Therapeutic Goods Legislation Amendment (Standard for Therapeutic Vaping Goods) (TGO 110) Instrument 2024.

Guidance to help manufacturers and sponsors navigate packaging terms across the industry, to meet regulatory requirements.

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.

This guidance describes the requirements for manufacturers and sponsors of faecal microbial transplant (FMT) products in TGO 105.

Guidance for the requirements applicable to medical devices containing poisons.

Guidance updated to reflect expectations of the new PIC/S guide to GMP PE009-13.

How to meet regulatory requirements for the manufacture and supply of menstrual cups in Australia.

Guidance on mandatory warning statements for labels of medicines containing neuromuscular blocking agents.

Guidance to help manufacturers of active medical devices, including software-based medical devices, to classify their devices.

Guidance for manufacturers and sponsors on the product standards that apply to haematopoietic progenitor cells (HPCs).

Guidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.

Guidance for sponsors on how and when to use a boxed warning in PI or a CMI.