Standards, guidelines & publications

Over-the-counter medicines

Standards and guidelines

• 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
• Colourings permitted in medicines for oral use
  List of colourings permitted in complementary, OTC and prescription medicines for oral use and provides indicative data requirements for the evaluation of new colours for inclusion in medicines for oral use
• 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.
• 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.

Tools for sponsors

• 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.