Over-the-counter (OTC) application categorisation framework

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

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.

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).

An application for a 'generic' medicine that:

• requires supporting safety and/or efficacy (clinical/toxicological) data or a justification for not providing the data. Examples of such applications are included below this table and/or
• has not previously been registered as an OTC medicine following down scheduling and /or
• includes a risk associated with an umbrella branding segment requiring a higher level of assessment.

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).

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

• New therapeutic indications
• New strength
• New dosage form
• New directions
• New combination medicines
• Different patient population

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

Requires both:

• Safety and/or efficacy data (supporting clinical and/or toxicological data) or a justification for not providing such data
• 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)

'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).

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).

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.

Includes changes:

• classified as 'low risk' to the quality and non-quality aspects of a medicine and requires assessment of supporting safety and/or efficacy data or a justification for not providing the data and/or
• to the medicine name where the new name includes a risk associated with an umbrella branding segment requiring a higher level of assessment.

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.

• Updated and converted the tables to be web accessible
• Revised the information regarding changes to medicines to remove the repetition.
• Changed table heading to more accurately represent the content i.e. replacement of the word 'definition' with 'categorisation'.
• Removed any unnecessary text and included hyperlinks to core guidance.
• Included risk rating for each table
• Deleted references to the New Zealand specific Information.