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Standards, guidelines & publications (OTC medicines)
Related information
Over-the-counter medicines
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Replaces the existing ARGOM (the superseded guidance will be progressively archived) - Proposed new notifications process: registered medicines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