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Use this tool to determine the correct application level for an OTC medicine application by answering a series of questions.
Text version of OTC application placement question and answer tool
This text representation of this flowchart is provided as a list with numbered steps.
- Is the product an OTC medicine?
- No: This is not the correct application route for the medicine. - End flowchart.
- Yes: Go to Step 2
- Is the application to register a new medicine or to make a change to an existing medicine?
- 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.
- New product: Go to Step 3
- Is the active a new chemical entity?
- Yes: The correct application level is N5 - End flowchart.
- No: Go to Step 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?)
- No: The correct application level is N5 - End flowchart.
- Yes: Go to Step 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?
- Yes: The correct application level is N4 - End flowchart.
- No: Go to Step 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?
- Yes: The correct application level is N4 - End flowchart.
- No: Go to Step 7
- Is the medicine a clone or flavour/fragrance/colour (FFC) variant that complies fully with all of the requirements for these applications?
- Yes: The correct application level is N1 - End flowchart.
- No: Go to Step 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?
- Yes: The correct application level is N4 - End flowchart.
- No: Go to Step 9
- Is the medicine modified release (excluding enteric coated tablets/capsules)?
- Yes: The correct application level is N4 - End flowchart.
- No: Go to Step 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.
- Yes: The correct application level is N4 - End flowchart
- No: Go to Step 11
- Is the medicine a formulation dependant topical? (This question is for Australian applicants only. For New Zealand applicants please select 'No' to proceed)
- Yes: The correct application level is N4 - End flowchart.
- No: Go to Step 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.
- Yes: The correct application level is N4 - End flowchart.
- No: Go to Step 13
- Does the medicine comply fully with a specific OTC Monograph and all of the associated general requirements?
- Yes: The correct application level is N2 - End flowchart.
- No: Go to Step 14
- The correct application level is N3.
- End flowchart
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 |