Supply a prescription medicine

In order for a prescription medicine to be registered in the Australian Register of Therapeutic Goods (ARTG) a sponsoring company (the sponsor) is required to submit an application to the Therapeutic Goods Administration (TGA).

An application to register a prescription medicine consists of:

• data that support the quality, safety and efficacy of the product for its intended use
• completed forms
• the payment of fees.

Australia has a 2-tiered system for the regulation of medicines.

• Higher risk medicines must be registered in the ARTG, which involves evaluating the quality, safety and effectiveness of the product.
• Lower risk medicines containing pre-approved, low-risk ingredients and that make limited claims can be listed in the ARTG.

For details on manufacturing prescription medicines go to Manufacture a medicine.

Steps to register a prescription medicine

Before you apply to register a prescription medicine in the ARTG, please read Prescription medicines registration process. This document explains the mandatory requirements, including:

• supporting documentation
• application pathways
• pre-submission planning
• application milestones
• scheduling
• concurrent applications
• mandatory requirements for an effective application.

If you need further guidance, consider whether you need a pre-submission meeting. See Pre-submission meetings with TGA.