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Standard pathway

Information on the stages of preparation, and application for Class 2, 3 or 4 biologicals.

Find information below on the preparation and submitting of an application for inclusion of a Class 2, 3 or 4 biological in the Australian Register of Therapeutic Goods (ARTG).

Guidance and resources

Applying for inclusion of a Class 2, 3 or 4 biological on the ARTG - a step-by-step guide

24 November 2022

Reference material

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