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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.