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ARGOM: Guidelines on the pre-market application and evaluation process for OTC medicines

Version 1.3, April 2014

29 November 2015

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Risk based approach to regulating OTC medicines

The TGA applies risk management principles described in the international risk management standard, ISO 31000:2009, to the regulation of therapeutic products. This standard was also used as the basis for the risk categorisation frameworks for OTC medicine applications.

Risks are rated in terms of the likelihood of an event occurring and the consequence if it were to occur. Consequence is the outcome of an event affecting objectives, whereas likelihood is the chance of something happening, whether defined, measured or determined objectively or subjectively, qualitatively or quantitatively, and described using general terms or mathematically (such as a probability or a frequency over a given time period).

Risk based application levels

For new product applications, there are five risk levels, from Level N1 to Level N5. For application to change an OTC medicine, there are four risk levels, from Level C1 to Level C4.

The application levels have timelines that are defined on the TGA website and submission requirements that are detailed in the OTC application categorisation framework and the OTC dossier documents matrix. OTC medicines that contain well-understood active ingredients and clones of existing OTC medicines fall into the lower risk levels, while more complex applications such as those involving new active ingredients or new indications fall into the higher risk levels. Lower risk application levels require less supporting information and follow a shorter timeline than applications in higher levels.

In summary, the application levels include:

  • N1. Clones and flavour/fragrance/colour variants.
  • N2. Generic medicines that fully meet a specific OTC monograph and all of the general requirements.
  • N3. Generic medicines that do not require data to support the safety or efficacy of the product.
  • N4. Includes generic medicines that:
    • require safety and/or efficacy data or a justification for not providing data. (For example, bioequivalence data, safety data to support a new excipient, or data to support a new label claim.)
    • have not been previously evaluated as an OTC medicine following down-scheduling.
    • require a higher level assessment due to the umbrella segment of the product name.
  • N5. New medicines that are not generics (e.g. new chemical entities, new indications).
  • C1. Minor changes (self-assessable requests and safety related requests) that were previously categorised as notifications in the ARGOM.
  • C2. Changes to quality aspects and non-quality aspects where no safety and efficacy data are required.
  • C3. Changes to the product name where a higher level of assessment is required due to umbrella branding. Non-quality changes where some safety and efficacy data may be required, other than C4 changes.
  • C4. Changes to the indications or directions for use where safety and efficacy data are required.

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