Mandatory Requirements for an Effective Over-the-counter Medicines Application

Therapeutic Goods (Groups) Order No. 1 of 2001 – OTC Medicine Registration Guidelines

The Therapeutic Goods (Groups) Order No. 1 of 2001 outlines the requirements for applications related to the registration of  over-the-counter (OTC) medicines. Key points include:

-Mandatory Information for Registration: The document specifies the required details for registering OTC medicines, including:

• Organization and format of application dossiers.
• Content of the dossier, ensuring all necessary information is included.
• Justification for any non-compliance with technical data requirements or guidelines.

New Registrations & Section 23 Instruments: The document covers procedures for new OTC medicine registrations and the use of Section 23 instruments for regulatory actions.

Updated Contact Information: The updated OTC contact email address was added on 20-Nov-2024 for inquiries and submissions.

This document serves as a comprehensive guide for companies seeking to register OTC medicines, ensuring compliance with regulatory standards.

Region: Australia

Source: https://www.tga.gov.au/publication/mandatory-requirements-effective-over-counter-medicines-application