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'.

• the product name does not include an umbrella segment categorised as requiring a higher level of assessment.

New Zealand specific

Additional classification due to an additional pack size of a previously approved product.

• Parent product must have been fully evaluated for safety, efficacy and quality [cannot be a 'grandfather' registered product] and the parent product must comply with current standards, including RASML in Australia and the Medsafe Labelling Statements Database in New Zealand.
• Full access to the rights of the parent product is provided.

An application which complies with an OTC Medicine Monograph, as described in ARGOM.

• the product name does not include an umbrella segment categorised as requiring a higher level of assessment¹.

• The product complies fully with the requirements of a specific OTC Medicine Monograph together with the Requirements for OTC New Product N2 applications (using OTC Monographs) document.

New application for a 'generic' medicine (as defined in ARGOM Appendix 1) other than those 'generic' applications in levels N1, N2 or N4

• the product name does not include an umbrella segment categorised as requiring a higher level of assessment¹.

• Does not entail evaluation of safety and efficacy data; safety and efficacy data are not required for applications at this level and should not be provided.
• Does not include applications included in Appendix X.
• Quality (CTD module 3) data are evaluated in full. However, in the circumstance where all quality aspects of the product are identical to a product which has previously been fully evaluated by the regulator, then the sponsor may provide an abbreviated module 3 dossier (including finished product specifications for the proposed product).

An application for a 'generic' medicine where the medicine:

1. is included in Appendix X (but which is not a level N1 application) and/or
2. includes an umbrella branded product name where the umbrella segment is categorised as requiring a higher level of assessment¹ and/or
3. requires supporting safety and/or efficacy (clinical/ toxicological) data or a justification for not providing such data.

• Quality (CTD module 3) data are evaluated in full. However, in the circumstance where all quality aspects of the product are identical to a product which has previously been fully evaluated by the regulator, then the sponsor may provide an abbreviated module 3 dossier (including finished product specifications for the proposed product).

An application for a new product that is an extension to a 'Generic category' product including:

• new therapeutic indications
• new strengths
• new dosage forms
• new directions
• new combination products
• different patient population

An application for a product containing a new chemical entity as an active ingredient.

• Safety and/or efficacy data (supporting clinical and/or toxicological data) or justification for not providing such data are required.
• Quality (CTD module 3) data are evaluated in full. However, in the circumstance where all quality aspects of the product are identical to a product which has previously been fully evaluated by the regulator, then the sponsor may provide an abbreviated module 3 dossier (including finished product specifications for the proposed product).

Quality and non-quality changes

• Includes minor non-quality and quality related changes

Changes identified in the 'Changes Table' (refer ARGOM) as Application Level C1.

Australia specific

This category would be equivalent to the types of changes previously categorised as an 'N' (notification) in ARGOM Ch.11

New Zealand specific

This category would be equivalent to the types of changes previously categorised as a 'Self-Assessable' change in the NZRGM

Quality changes¹

• Changes to quality aspects of a product excluding changes described in levels C1 or C4

Non-quality changes - no safety & efficacy data required¹

• Changes to the non-quality aspects of the product excluding changes described in C1, C3 or C4 and excluding changes requiring the provision of safety and efficacy data (or a justification for not providing such data).

Changes identified in the 'Changes Table' (refer ARGOM) as Application Level C2.

• Includes changes to product name except those changes involving an umbrella branded product where the umbrella segment is categorised as requiring a higher level of assessment² - assessed in level C3.
• This application level can include changes to a product involving a new indication or directions for use / new patient population but only where the provision of safety & efficacy data are not required. For example, a new indication for a registered product where that indication has been previously evaluated and approved for a very similar ('generic') product.

New Zealand specific

If changing the product name:

• a change application is required if the product is replacing an existing product
• a new product application is required if adding a new product.

Umbrella branding: higher level of assessment1

• Changes to the product name where the new name includes an umbrella segment categorised as requiring a higher level of assessment²

Non-quality changes - safety & efficacy data may be required¹

• Changes requiring evaluation of safety and/or efficacy data (or a justification for not providing such data) to support changes to labelling (incl. PI or Data sheet / CMI) except those changes described in C4

Changes identified in the 'Changes Table' (refer ARGOM) as Application Level C3.

Non-quality changes – data are required¹

• Where safety and efficacy data (clinical and/or toxicological) are required to support the proposed changes or where a justification for not providing such data would be required.

Quality changes¹

[New Zealand specific]

• New type of manufacturing process for a finished product
• New manufacturing process for an active ingredient
• New container / closure / packaging
• Formulation changes

Changes identified in the 'Changes Table' (refer ARGOM) as Application Level C4.