Over-the-counter (OTC) application placement flowchart

Introduction

The OTC application placement flowchart (the 'flowchart') is a tool to assist the sponsor in categorising an application to register a 'new' medicine into the appropriate application level. Sponsors wanting to change the details of a currently registered OTC medicine are referred to the Process to change a registered OTC medicine.

The flowchart has been developed primarily to assist the sponsor or regulatory affairs consultant experienced in the OTC regulatory environment to quickly categorise their application into the correct level. The sponsors who are less experienced in the OTC regulatory environment and those users less familiar with the terminology used in the flowchart, such as 'generic' medicine and 'umbrella branding issue', will still benefit from the use of the flowchart as a general guidance but would be advised to refer closely to the guidance documents specified within the document and the accompanying tools such as the OTC application categorisation framework and/or the OTC application placement Q&A tool to confirm the application level.

OTC application placement flowchart

Text version of OTC application placement flowchart

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

1. New or change application?
   Is this an application for a new OTC medicine or a change to a registered OTC medicine?
   1. CHANGE: Refer to Process to change a registered OTC medicine - end flowchart
   2. NEW: Go to Step 2
2. Generic?
   Is the proposed new medicine a 'generic OTC medicine'? (Also see OTC medicines - Safety and efficacy data).
   1. NO: Application level is N5 - end flowchart
   2. YES: Got to Step 3
3. Umbrella branding issue?
   Does the product include an umbrella segment that requires a higher level of assessment? (Refer OTC application route for umbrella branded medicines).
   1. YES: Application level is N4 - end flowchart
   2. NO: Go to Step 4

4. Clone or variant of a fragrance/flavour/colour ('FFC')?
   Is the application for either:

   1. a clone of a fully evaluated parent; or
   2. for a FFC variant of a fully evaluated parent (where the total content of the FFC agent(s) is present at ≤2%)?

   As detailed in OTC new medicine N1 applications

   1. YES: Application level is N1 - end flowchart
   2. NO: Go to Step 5
5. Safety/efficacy data required, higher level umbrella brand assessment, or not previously registered as an OTC medicine following down scheduling?
   Do one or more of the following apply?;
   • Data required to support the safety and/or efficacy of the product.
   • Medicine not previously registered as an OTC following down scheduling
   • Includes an umbrella brand that requires a higher level of assessment.
   1. YES: Application level is N4 - end flowchart
   2. NO: Go to Step 6
6. Monograph?
   Does the product fully meet all the requirements of an OTC Medicines Monograph?
   1. YES: Application level is N2 - end flowchart
   2. NO: Application level is N3 - end flowchart