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Mandatory requirements for an effective application to vary the Permissible Ingredients Determination
This document describes the information (and the form of that information) that must be submitted for an application under section 26BD of the Therapeutic Goods Act 1989 (‘the Act’) to vary the Therapeutic Goods (Permissible Ingredients) Determination to pass preliminary assessment and proceed to evaluation.
These requirements apply to applications for the addition of new ingredients, or variation of existing ingredients, as listed in the Permissible Ingredients Determination, that are lodged with the TGA from 1 February 2023, including applications for a proposed new role, route of administration, or a change to the existing requirements for use of a current permitted ingredient.
Background
All listed medicines (AUST L listed medicines and AUST L[A] assessed listed medicines) may only contain ingredients included in the Permissible Ingredients Determination. The Permissible Ingredients Determination is a legislative instrument made by the Minister for Health and Aged Care under section 26BB of the Act.
For a new substance to be included or an existing substance to be varied in the Permissible Ingredients Determination, an applicant must make an application to the Secretary under section 26BD of the Act for a recommendation that the Minister vary the Permissible Ingredients Determination.
Subsection 26BD(3) requires that applications:
- are made in accordance with a form determined by the Secretary; and
- be accompanied by the kind of information determined by the Secretary.
Therapeutic Goods (Information that must accompany application made under section 26BD of the Therapeutic Goods Act 1989) Determination
The Therapeutic Goods (Permissible Ingredients—Information that Must Accompany Application for Variation) Determination 2023 specifies how applications for substances to vary the Permissible Ingredients Determination must be made and requires applications to include the information described in the ‘Mandatory requirements for an application to vary the Permissible Ingredients Determination’ to pass preliminary assessment and proceed to evaluation.
For information on the different levels of substance applications (IN1-IN4) that are referred to in this document, the application process, and further detail on individual requirements, please see: