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Mandatory requirements for an assessed listed medicine application to pass preliminary assessment
Version 1.0, March 2018
This document describes the information (and the form of that information) that must be submitted to the TGA in order for an application to list an assessed listed medicine in the Australian Register of Therapeutic Goods (ARTG) to pass preliminary assessment and proceed to evaluation.
These requirements apply to applications to list an assessed listed medicines in the ARTG that are lodged with the TGA from March 2018, including applications to change an assessed listed medicine that results in a separate and distinct good under subsection 16(1) of the Therapeutic Goods Act 1989 (the Act) to which the Therapeutic Goods (Groups) Order No. 1 of 2001 applies.
Application for new assessed listed medicines
Applications for new listings in the ARTG as an assessed listed medicine are made under section 23B of the Act. Section 23B requires that applications:
- are made in accordance with a form or in a manner approved by the Secretary (subparagraph 23B(2)(a)(i) of the Act); and
- include such information in a form approved by the Secretary as will allow the determination of the application (subsection 23B(9) and 23B(10) of the Act)
Section 23 instruments
The Section 23 instruments specify how applications to list a complementary medicine under section 26AE of the Act ('assessed listed medicines') must be made and require applications to include the information described in the following regulatory documents in order to pass preliminary assessment and proceed to evaluation:
- Mandatory requirements for an effective assessed listed medicine application (this document); and
- CTD Module 1: Administrative information for assessed listed medicines