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OTC new medicines registration process

27 August 2020

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Step 3 - Determining your application level

Applications to register an OTC medicine are categorised into five levels, based on risk and have different fees and target evaluation times.

Determining the correct application level

It is important that you determine the correct application level.

If your application does not include the required data, in accordance with the application level, it will not be accepted for evaluation under section 23(2)(b) of the Therapeutic Goods Act 1989.

Five application levels for new OTC medicines

  1. N1 Generic medicines that meet the requirements for OTC new medicine N1 applications (clones or flavour/fragrance/colour variants of a currently registered medicine).
  2. N2 Generic medicines that fully meet a specific OTC monograph and the general requirements for OTC New Medicine N2 applications.
  3. N3 Generic medicines that are not an N1, N2 or N4 level application (N3 applications require CTD Modules 1 and 3).
  4. N4 Generic medicines that are one or more of the following:
    • require supporting safety and/or efficacy data
    • have not been previously registered as an OTC medicine following down - scheduling
    • require a higher level assessment due to the umbrella segment of the product name.
  5. N5 New medicines that are not generics, including either one or more new:
    • active ingredient (new chemical entity)
    • combination of active ingredients
    • indication
    • strength
    • dosage form
    • directions for use
    • patient population.

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