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.
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).
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 dosage forms
different directions for use
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)
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.