Standards, guidelines & publications (OTC medicines)
- Australian regulatory guidelines for OTC medicines (ARGOM)
These Guidelines describe the information to be supplied with an application for registration of OTC (over-the-counter) medicines in the Australian Register of Therapeutic Goods
- Australian regulatory guidelines for sunscreens (ARGS)
These Guidelines describe the regulatory requirements and standards for sunscreens and their ingredients in Australia
- European Union guidelines
Lists of European Union Guidelines relating to medicines, both those published as adopted in Australia and those published as not adopted in Australia.
- Guidance 22: Colourings used in medicines for oral use
These guidelines relate to colourings in medicines for oral use that do not require evaluation of data by the TGA, and the information required to evaluate a colouring that is not in the published list of permitted colours
- Guidelines for levels and kinds of evidence to support indications and claims
These guidelines assist sponsors in determining the appropriate evidence to support indications and claims made in relation to Listable medicines.
- OTC medicines electronic lodgement and update of existing ARTG records
Provides general information about the TGA's eBusiness Services for OTC medicines sponsors, how to access it and how to use it
- TGA approved terminology for medicines
Lists of Australian Approved terminology that ensure accuracy and consistency in the information compiled in the ARTG. For medicines, the lists cover substances (active ingredients and excipients), containers, dosage forms, routes of administration and units of expression and proportion.
- Frequently asked questions about the new OTC business process (commenced April 2013)
Frequently asked questions and answers on the new OTC BPR process which commenced on 15 April 2013 and will be implemented in stages over 12 months, with full implementation in April 2014
- Determining the correct application level and supporting information required for OTC medicines submissions
OTC medicine applications are categorised according to risk, with five risk levels for applications for new medicines and four risk levels for applications to make changes to existing medicines
- OTC application categorisation framework
The OTC application categorisation framework defines the different OTC medicine application levels and the key application criteria
- OTC application route for umbrella branded medicines
The OTC Application Categorisation Framework defines the different application levels for applications for new medicines, and changes to existing medicines. Within this framework, applications for umbrella brand extensions are identified as requiring an increased level of assessment when the risks to consumers are considered to be higher.
- OTC application placement flowchart
This flowchart is a tool to assist the sponsor in categorising an application to register a 'new' medicine into the appropriate application level.
- OTC application placement question and answer tool
Use this tool to determine the correct application level for an OTC medicine application by answering a series of questions.
- OTC dossier documents matrix
This matrix provides a summary of which documents are required for each application level.
Web page last updated: Thursday, 12 September 2013