OTC application placement question and answer tool

Version 1.1, May 2016

10 May 2016

Use this tool to determine the correct application level for an OTC medicine application by answering a series of questions.

How to access a pdf document

Text version of OTC application placement question and answer tool

This text representation of this flowchart is provided as a list with numbered steps.

  1. Is the product an OTC medicine?
    1. No: This is not the correct application route for the medicine. - End flowchart.
    2. Yes: Go to Step 2
  2. Is the application to register a new medicine or to make a change to an existing medicine?
    1. Change: Use the guidelines Changing an OTC medicine: using the Changes Tables to determine which application level applies to each change. The application needs to be submitted at the highest applicable level. - End flowchart.
    2. New product: Go to Step 3
  3. Is the active a new chemical entity?
    1. Yes: The correct application level is N5 - End flowchart.
    2. No: Go to Step 4
  4. Does the medicine have the same:
    • quantity per dose of each of the active substances, and
    • dosage form, and
    • safety and efficacy properties, for example
      • directions for use
      • indications
      • target population
    as a fully evaluated approved OTC medicine? (ie. Is it a 'generic' medicine?)
    1. No: The correct application level is N5 - End flowchart.
    2. Yes: Go to Step 5
  5. Use the flowchart for determining the assessment level for umbrella branded medicines. Does the product name include an umbrella segment that is categorised as requiring a higher level of assessment?
    1. Yes: The correct application level is N4 - End flowchart.
    2. No: Go to Step 6
  6. Is the application for a medicine that was previously a 'Prescription Only Medicine' and no such medicine has been approved as an OTC medicine?
    1. Yes: The correct application level is N4 - End flowchart.
    2. No: Go to Step 7
  7. Is the medicine a clone or flavour/fragrance/colour (FFC) variant that complies fully with all of the requirements for these applications?
    1. Yes: The correct application level is N1 - End flowchart.
    2. No: Go to Step 8
  8. Are safety data or a justification for not providing safety data required because the medicine contains:
    1. Yes: The correct application level is N4 - End flowchart.
    2. No: Go to Step 9
  9. Is the medicine modified release (excluding enteric coated tablets/capsules)?
    1. Yes: The correct application level is N4 - End flowchart.
    2. No: Go to Step 10
  10. Is bioequivalence data or a justification for not providing bioequivalence data required to support the application, either because:
    • the medicine is a generic of a registered medicine for which such data are required.
    • a brand equivalence statement has been requested.
    1. Yes: The correct application level is N4 - End flowchart
    2. No: Go to Step 11
  11. Is the medicine a formulation dependant topical? (This question is for Australian applicants only. For New Zealand applicants please select 'No' to proceed)
    1. Yes: The correct application level is N4 - End flowchart.
    2. No: Go to Step 12
  12. Is safety or efficacy data required for any other reason? For example, to support a statement in the PI document or a label claim.
    1. Yes: The correct application level is N4 - End flowchart.
    2. No: Go to Step 13
  13. Does the medicine comply fully with a specific OTC Monograph and all of the associated general requirements?
    1. Yes: The correct application level is N2 - End flowchart.
    2. No: Go to Step 14
  14. The correct application level is N3.
  15. End flowchart
Version history
Version Description of change Author Effective date
V1.0 Original publication OMA - OTCME April 2013
V1.1 Update to hyperlinks and superseded references COMB-OTCME May 2016