Mandatory requirements for an effective over-the-counter medicines application

On this page: Overview | Scope | Background | Version history

Overview

This document describes the information (and the form of that information) that must be submitted to the TGA in order for an application to register an over-the-counter (OTC) medicine to be considered effective and proceed to evaluation.

Scope

These requirements apply to applications to register an OTC medicine that are lodged with the TGA from 1 March 2016, including applications to change a registered OTC medicine that result 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.

Background

Applications for new registrations

Applications for new registrations are made under section 23 of the Act. Section 23 requires that applications:

• are made in accordance with a form or in a manner approved by the Secretary (subsection 23(1) of the Act; and
• include such information in a form approved by the Secretary as will allow the determination of the application (paragraph 23(2)(b) of the Act); and
• for restricted medicines include product information in the form approved under section 7D of the Act (paragraph 23(2)(ba) of the Act).
  1. A new registration is one that requires a new ARTG entry by reason of being separate and distinct goods under section 16 of the Act. This includes:
     • • new chemical entities
       • new strengths
       • new dosage forms
       • different directions for use
       • formulation changes
       • changes in trade name
       • extension of indication, etc.

Under the Therapeutic Goods (Groups) Order 2001, not all new registrations will result in a new AUST R number being allocated if the existing medicine is 'grouped' with the new medicine.

Section 23 instruments

The section 23 instruments specify how applications to register an OTC Medicine must be made and require applications to include the information described in the following regulatory documents in order to be effective and proceed to evaluation:

• Mandatory requirements for an effective over-the-counter medicine application (this document)
• CTD Module 1: OTC medicines.

OTC medicine applications

For information on the OTC application levels that are referred to in this document, and the application process, go to:

• Determining the correct application level for OTC medicines submissions
• OTC New medicine registration process
• Process to change a registered OTC medicine
• Changing an OTC medicine: using the changes table.

Version history