OTC application placement question and answer tool

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:
   • a new excipient or
   • an excipient with a new route of administration or at a higher dosage than allowed?
   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