On this page: Standards and guidelines | Tools for sponsors

Standards and guidelines

• Australian regulatory guidelines for OTC medicines (ARGOM)
  Replaces the existing ARGOM (the superseded guidance will be progressively archived)
• Proposed new notifications process: registered medicines
  Guidance on proposed new notifications process for registered medicines to support anticipated changes to legislation
• Scientific guidelines
  Lists of European Union Guidelines relating to medicines
• Colourings used in medicines for topical and oral use
  Lists the colourings that may be used in topical and oral medicines, the regulatory and data requirements for new colourings
• TGA approved terminology for medicines
  Lists of approved terminology that ensure accuracy and consistency in the information compiled in the ARTG

Tools for sponsors

• Determining the correct application level and supporting information required for OTC medicines submissions
  OTC medicine applications are categorised according to risk
• OTC application categorisation framework
  Defines the different OTC medicine application levels and the key application criteria
• OTC application route for umbrella branded medicines
  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
  Tool to assist sponsors in categorising applications to register a 'new' medicine into the appropriate application level
• OTC application placement question and answer tool
  Tool to determine the correct application level for an OTC medicine application
• OTC dossier documents matrix
  Provides a summary of which documents are required for each application level