Guidance

This guidance outlines pharmacists’ regulatory responsibilities when supplying therapeutic vapes to support patients in quitting smoking or managing nicotine dependence.

Guidance on providing adventitious agent safety information in applications for medicines containing, or manufactured using, materials of animal or human origin.

Guidance on TGO 109: Standards for Biologicals - General and Specific Requirements.

Guidance explaining how the method of preparation influences classification and whether autologous HCTs are eligible for exemptions.

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

Guidance to help determine whether products are separate and distinct biologicals that will need to be included as separate ARTG entries.

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

Guidance to help work out if your autologous HCT product is exempt from some aspects of our regulation.

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

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.

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

Guidance on the application of the Therapeutic Goods (Vaping Goods - Possession and Supply) Determination 2024.

Australian Regulatory Guidelines for Biologicals (ARGB). This guidance will help you understand how to classify your biological.

Guidance for preparing and submitting an application for inclusion of a Class 1 biological on the ARTG.

From 1 March 2024, a sponsor notice must be given by a sponsor of a vaping good to the TGA before the good is imported into, or supplied in, Australia following domestic manufacture.

Risk management plans for medicines and biologicals has been updated with new content, new Australia-Specific Annex and a new form.

Guidance on the two mechanisms to provide information about a drug substance sourced from a third-party manufacturer.