The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
The OTC application categorisation framework defines the different OTC medicine application levels and identifies the key application criteria. This document assists sponsors to identify the appropriate application level when applying to register an OTC medicine or make a change to a registered OTC medicine.
New medicines
| Application level | Definition of the application level | Key application criteria |
|---|---|---|
| N1 | An application submitted as a 'Clone' described in the OTC new N1 applications An application for a flavour/fragrance/colour (FFC) variant of a fully evaluated parent where the total content of the FFC agent(s) affected is ≤ 2% w/w or w/v and where the medicine otherwise meets all the requirements applying to a 'Clone'. The medicine name does not include a risk associated with an umbrella branding segment that requires a higher level of assessment. | Parent medicine must have been fully evaluated for safety, efficacy and quality [cannot be a 'grandfather' registered medicine] and must comply with current standards, including RASML. Full access to the rights of the parent medicine is provided |
| N2 | An application which complies with an OTC Medicine Monograph, as described in OTC N2 applications and OTC medicine monographs. The medicine name does not include a risk associated with an umbrella branding segment that requires a higher level of assessment. | The medicine complies fully with the requirements of a specific OTC Medicine Monograph together with the Requirements for OTC new medicines N2 applications (using OTC Monographs). |
| Application level | Definition of the application level | Key application criteria |
|---|---|---|
| N3 | New application for a 'generic' medicine other than those in levels N1, N2 or N4 The medicine name does not include a risk associated with an umbrella branding segment that requires a higher level of assessment. | Does not entail evaluation of safety and efficacy data. Do not provide safety and efficacy data for applications at this level. Requires full evaluation of Quality data (CTD module 3). However, in the circumstance where all quality aspects of the product are identical to a product which has previously been fully evaluated by the TGA, then you may provide an abbreviated module 3 dossier (including finished product specifications for the proposed product). |
| N4 | An application for a 'generic' medicine that:
| Requires evaluation of Quality data (CTD module 3). However, in the circumstance where all quality aspects of the product are identical to a product which has previously been fully evaluated by the TGA, then you may provide an abbreviated module 3 dossier (including finished product specifications for the proposed product). |
Examples of generic applications requiring safety and/or efficacy data
- Modified release medicines (excluding enteric coated tablets/capsules)
- A generic medicine application requiring bioequivalence data or a justification for not providing the data
- Medicines with:
- a new excipient
- an excipient with a new route of administration
- an excipient at a higher concentration than that which has previously been approved.
- Applications for medicines that require both:
- a brand equivalence statement
- bioequivalence data or a justification for not providing the data
- Formulation dependent topical medicines.
| Application level | Definition of the application level | Key application criteria |
|---|---|---|
| N5 | An application for a new medicine that is an extension to a 'Generic category' medicine including:
An application for a medicine containing a new chemical entity as an active ingredient. | Requires both:
|
Changes to medicines
NOTE: Where a change application includes multiple changes covering different categories, the whole application is to be classified at the level of the highest category change in the application.
| Application level | Categorisation of application level | Key application criteria |
|---|---|---|
| CN | Changes identified in the Changes Table as application level CN | 'Notification' changes, where their implementation would not impact the quality, safety or efficacy of a medicine. Includes changes classified as 'negligible risk' to the quality and non-quality aspects of a medicine. Does not require assessment of safety, efficacy and/or quality data (or a justification for not providing such data). |
| C1 | Changes identified in the Changes Table as application level C1 | Includes changes classified as 'negligible risk' to the quality and non-quality aspects of a medicine. Does not require assessment of safety, efficacy and/or quality data (or a justification for not providing such data). |
| Application level | Categorisation of application level | Key application criteria |
|---|---|---|
| C2 | Changes identified in the Changes Table as application level C2 | Includes changes classified as 'low risk' to the quality and non-quality aspects of a medicine. Does not require assessment of safety and/or efficacy data (or a justification for not providing such data). May require assessment of quality data. |
| C3 | Changes identified in the Changes Table as application level C3 | Includes changes:
|
| Application level | Categorisation of application level | Key application criteria |
|---|---|---|
| C4 | Changes identified in the Changes Table as application level C4 | Includes non-quality changes classified as 'moderate risk'. Requires assessment of safety and/or efficacy data (clinical and/or toxicological) to support the proposed changes or a justification for not providing the data. |
| Version | Description of change | Author | Effective date |
|---|---|---|---|
| V1.0 | Original publication | OMA - OTCME | April 2013 |
| V1.1 |
| OTC Medicines and Regulatory Guidance | 30 November 2015 |
| V1.2 | Updated to include CN application level | OTC Medicines Evaluation Section / Scientific Operations Management Section | June 2017 |