Supplying biologicals

Guidance for people who want to access biologicals that are not included on the Australian Register of Therapeutic Goods (ARTG).

An outline of the regulatory process and a summary of the requirements to successfully submit a biologicals application.

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

This guidance outlines the information needed in your dossier for us to be able to effectively review your application for a biological therapeutic good.

Guidance on the stages of preparing and submitting an application for inclusion of a Class 2, 3 or 4 biological in the ARTG.

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

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

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).

This guidance is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a biological

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

This guidance is for all sponsors of products regulated as biologicals.

Guidance about how to promote your business and service, without advertising biologicals to the public.

Release on non-conforming biologicals is only permitted under prescribed circumstances and for an individual patient. Access to the request form and instructions are within the guidance document.