
You are here
The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.
OTC application categorisation framework
Related information
Version 1.0, March 2013
Introduction
The OTC application categorisation framework defines the different OTC medicine application levels and the key application criteria.
New medicines - application categorisation framework
Risk rating | Application level | Definition of application level | Key application criteria | |
---|---|---|---|---|
Negligible | New generic medicines | N1 |
An application submitted as a 'Clone', as described in ARGOM. 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 product otherwise meets all the requirements applying to a 'Clone'.
New Zealand specificAdditional classification due to an additional pack size of a previously approved product. |
|
N2 |
An application which complies with an OTC Medicine Monograph, as described in ARGOM.
|
|
||
Low | N3 |
New application for a 'generic' medicine (as defined in ARGOM Appendix 1) other than those 'generic' applications in levels N1, N2 or N4
|
|
|
N4 |
An application for a 'generic' medicine where the medicine:
|
|
||
Moderate | Generic extensions / NCE | N5 |
An application for a new product that is an extension to a 'Generic category' product including:
An application for a product containing a new chemical entity as an active ingredient. |
|
Footnote
- Refer to OTC Application Route for Umbrella Branded Medicines for the determination of correct application level for umbrella branded medicines
Appendix X
- Modified release products (excluding enteric coated tablets/capsules).
- Application for a generic of a registered product where bioequivalence data are required or where a justification for not providing bioequivalence is required.
- Product includes a new excipient, an excipient with a new route of administration or an excipient at a higher concentration than that which has previously been approved.
- Applications for products where a brand equivalence statement is requested and where bioequivalence evaluation is required or where a justification for not providing bioequivalence is required.
- Formulation dependent topical products.
- An application for an OTC product as a result of a change in scheduling for the particular product from the 'Prescription Only Medicine' schedule to a lower (OTC) schedule, where no such products are previously approved as an OTC medicine.
Changes to approved medicines - application categorisation framework
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.
Risk rating | Appliation level | Definition of application level | Key application criteria |
---|---|---|---|
Negligible | C1 |
Quality and non-quality changes
|
Changes identified in the 'Changes Table' (refer ARGOM) as Application Level C1. Australia specificThis category would be equivalent to the types of changes previously categorised as an 'N' (notification) in ARGOM Ch.11 New Zealand specificThis category would be equivalent to the types of changes previously categorised as a 'Self-Assessable' change in the NZRGM |
Low | C2 |
Quality changes1
Non-quality changes - no safety & efficacy data required1
|
Changes identified in the 'Changes Table' (refer ARGOM) as Application Level C2.
New Zealand specificIf changing the product name:
|
C3 |
Umbrella branding: higher level of assessment1
Non-quality changes - safety & efficacy data may be required1
|
Changes identified in the 'Changes Table' (refer ARGOM) as Application Level C3. |
|
Moderate | C4 |
Non-quality changes – data are required1
Quality changes1[New Zealand specific]
|
Changes identified in the 'Changes Table' (refer ARGOM) as Application Level C4. |
Footnotes
- New Zealand specific: may be referred for assessment under section 24(5) of the Medicines Act 1981
- Refer to OTC Application Route for Umbrella Branded Medicines for the determination of correct application level for umbrella branded medicines
Version | Description of change | Author | Effective date |
---|---|---|---|
V1.0 | Original publication | OMA - OTCME | April 2013 |