The APVMA is aware that overseas holders are not currently able to submit item 24V applications through the online services portal. We are looking at rectifying this issue and until this is rectified overseas holders are requested to submit an item 18 application instead, noting in their executive summary that they would have submitted the application as an item 24V (specifying the modules that would have been included), and requesting a fee waiver for the cost difference.
From 1 February 2023, new chemistry and health modules with lower fees and timeframes that are applicable to some categories of active constituent application came into force. The chemistry and relevant health modules applicable to active constituent applications from 1 February 2023 are listed in Table 1.
| Module | Fee | Timeframe | Situation* |
|---|---|---|---|
| Chemistry 1 (2.1) | $11 074 | 13 months | New active constituent requiring a full chemistry assessment with or without an accompanying product |
| Chemistry 2 (2.2) | $3 075 | 9 months | New biological or industrial chemical active with or without an accompanying product |
| Chemistry 3 (2.3) | $1 954 | 6 months | New source of existing active other than those described in Chemistry 5 (2.5) Variation to an approval for an existing active constituent, other than those described in Chemistry 4 (2.4) or Chemistry 5 (2.5) |
| Chemistry 4 (2.4) | $970 | 3 months | Variation to an approval for an existing active constituent not complying with a monograph in BP, Ph Eur or USP to add a new site of manufacture with no change in manufacturing process or specifications/Declaration of Composition. |
| Chemistry 5 (2.5) | $480 | 2 months | New source of existing active complying with a monograph in BP, Ph Eur or USP Variation to an approval for an existing active complying with a monograph in BP, Ph Eur or USP. |
| Health 2 (3.2) | $27 920 | 11 months | Health assessment for a new active with food crop/animal uses and not mentioned in Health 3 or 4 where no exposure assessment is required due to any product being assessed separately (Health 1 is available to cover concurrent assessment of a new active and an associated product). |
| Health 3 (3.3) | $18 980 | 9 months | Health assessment for a new active without food uses and not mentioned in Health 4. |
| Health 4 (3.4) | $7 963 | 5 months | Health assessment for a new biological active constituent. |
| Health 6 (3.6) | $2 000 | 2 months | Health assessment for novel impurities in a new source of an approved active. |
* For further information on the modules and application types, please see the module descriptors.
From 1 February 2023, applicants have been able to make applications for approval of and variation to active constituents as an Item 24 modular application type.
What is an Item 24?
Item 24 is a modular application item made under section 10 or 27 of the Agvet Code and requiring a technical assessment, other than those covered by Items 1 to 18. It can be used for applications for active constituent approvals or variations to existing approvals. In the latter case, it is also referred to as an Item 24V. Whilst Item 24 is effectively a miscellaneous application item to cover situations not picked up by other application items, it can now be used more widely for active constituent approvals as all current items specific to active constituent approval (Items 15-18) are fixed fee and timeframe application items and do not allow the use of the new lower fee and timeframe chemistry modules.
Which application item should I choose?
Depending on the type of application, different items will be appropriate. The relevant application items for active constituents, including applications for active constituent approval in conjunction with a product registration, are summarised below.
Item 15
This application item is a fixed fee and timeframe item, costing $38,776 and with a timeframe of 14 months (prior to any extension due to a 159 notice). This should be used for applications for approval of a new active constituent without an associated product registration, and where a full assessment is required for chemistry and toxicology, and poison scheduling is required.
Item 15 incorporates a Chemistry 1 assessment, a Health 2 assessment, and a Poison Scheduling module, along with modules for Preliminary Assessment, Finalisation 1 and Limits on Use of Information.
In situations where you are also seeking registration of a product, an application item covering both approval of a new active constituent and registration of a product (Items 1, 2 or 27) may be more cost- and time-effective.
For approvals of new active constituents where a lower level of chemistry and/or health assessment is required, or poison scheduling is not required (e.g. due to an existing appropriate listing in the Poison Standard for other uses such as human pharmaceuticals), it may be cheaper and/or faster to use an Item 24 with the appropriate modules.
More detailed advice on specific scenarios can be given via pre-application assistance.
Item 16
This application item will no longer be routinely available by direct submission into the PPLA, as in most circumstances, a modular application under an Item 24 will be more cost or time effective. Item 16 will still be available as a recategorized item in case it proves to be the most expedient option for a particular application.
Item 17
This application item is a fixed fee and timeframe item, costing $5,442 and with a timeframe of 7 months (prior to any extension due to a 159 notice). This should be used for applications for a new active constituent approval where no toxicological assessment is required. It incorporates a Chemistry 3 assessment together with appropriate modules for preliminary assessment, finalisation and limits on use of information.
Most Item 17 applications are for new approvals of existing active constituents, although they have occasionally used for approval of new active constituents where no toxicological assessment is required.
Item 17 chemistry assessments include evaluation of spectroscopic identification, manufacturing process and quality control, batch analyses, specifications or Declaration of Composition, and analytical methods. Item 17 is appropriate for approval of new sources of existing actives which are not covered by a monograph in an APVMA recognised pharmacopoeia (BP, Ph Eur or USP). New source approvals for the majority of agricultural active constituents as well as veterinary active constituents manufactured to standards other than BP, Ph Eur or USP (commonly referred to as manufacturers specifications or MS actives) are considered under Item 17s.
Where a health assessment is required for an active constituent approval, an Item 17 application cannot be used and Item 24 is likely to be the appropriate option. Item 24s will also be used where a lower level of chemistry assessment than a Chemistry 3 is required.
More detailed advice on specific scenarios can be given via pre-application assistance.
Item 18
Item 18 is for variations to the particulars or conditions of an existing active approval. It is a fixed fee ($4,252) and timeframe (7 months) item. Some variation applications for existing active approvals may now be made through a Chemistry 4 or Chemistry 5 assessment, in which case an Item 24 (see below) will be a cheaper and faster option than an Item 18. Item 18 remains the appropriate option for variations to existing active approvals requiring a Chemistry 3 assessment. Common uses for Item 18s (or 24Vs, see below) are to add or substitute one or more sites of manufacture for an existing approval, or to change the specifications (composition and purity) for an approved active.
More detailed advice on specific scenarios can be given via pre-application assistance.
Notifiable variation (NV)
An NV can be used for some very minor variations to an active constituent approval:
- A change to the name of a manufacturer of an active constituent
- A change to the address of the site of manufacture of an active constituent where there is no physical change of location (e.g., a change in a street name or numbering)
Further information on NVs can be found on the APVMA website.
Item 24/24V
Item 24 is a modular application item that can be used for a new approval (Item 24) or variation of an existing approval (Item 24V) for active constituents.
There are a number of scenarios where an Item 24/24V will be appropriate for your active constituent application.
- Approval or variation of an approval for a new source of an existing active constituent manufactured to the standard of a monograph in BP, Ph Eur or USP and requiring a Chemistry 5 assessment.
- Variation of an approval for an existing active constituent not complying with a BP, Ph Eur or USP monograph to add a new manufacturing site with no change in manufacturing process or specifications and requiring a Chemistry 4 assessment.
- Approval of a new active constituent that does not require full assessments for chemistry, health and poison scheduling.
- Approval of a new source of an existing active constituent where a health assessment is required for manufacturing impurities that have not been covered by a previous health assessment. In this case, applications are often recategorized from Item 17 once new impurities are identified as part of the chemistry assessment.
How do I submit an Item 24?
The decision tree and online services portal has now been updated to include the ability to submit both Item 24 and Item 24V applications. You will see in the decision tree several new questions for active constituents under both the approval and variation pathway to give an Item 24 decision ID. These questions are labelled with Item 24 in addition to providing examples of what is submitted under an Item 24 to make them easy to differentiate.
The application form is used for both Item 24 and 24V applications and our administration staff at creation will correctly assign them as item 24 or 24V applications. If you are submitting a variation, please make sure to include the active number of the active constituent you wish to be varied as part of your submission.
If you have a draft application currently in progress as an Item 17 or Item 18 that meets the Item 24 criteria, please clearly state in the executive summary that you want your application to be an Item 24 application and list the modules required. If you have submitted an application and it has not passed preliminary assessment, please forward the request for consideration as an Item 24 or 24V to the APVMA Enquiries Team.
If you have any further questions, please contact enquiries@apvma.gov.au.
Which modules should I choose for my Item 24 and what will the fee and timeframe be?
While an Item 24 is modular and therefore it is not possible to give an answer for all possible scenarios, the modules, fees and timeframes for some common situations for use of an Item 24 are summarised in Table 2.
| Situation | Modules | Fees | Timeframe |
|---|---|---|---|
| Approval of a new source or variation of an approval for an active complying with a BP, Ph Eur or USP monograph. | Preliminary Assessment Chemistry 5 Finalisation 3 | $902 $480 $1 730 (total $3 112) | 4 months, 7 months (extended assessment period) |
| Variation of an active approval where active does not comply with a monograph in BP, Ph Eur or USP to add a new manufacturing site with no change in manufacturing process or specifications. | Preliminary Assessment Chemistry 4 Finalisation 3 | $902 $970 $1 730 (total $3 602) | 5 months, 8 months (extended assessment period) |
| Approval of a new source of an existing active constituent where a toxicological assessment is required for new impurities. | Preliminary Assessment Health 6 | $902 $1 954 $2 000 $3 090 (total $7 946) | 8 months, 12 months (extended assessment period) |
Application types for concurrent approval of an active constituent and product registration
Item 1
This is a fixed fee ($116,501) and timeframe (18 months) application item covering approval of a new active constituent and registration of a product and requiring a full assessment across all scientific assessment areas.
Item 2
This is a modular application item for approval of an active constituent and registration of a product that is generally used for products with new actives where a full assessment is not required for all areas.
Item 27
This is a modular application item for timeshift applications where the data dossier is submitted in stages, rather than only at the time of application. Item 27 can be used for a full range of application types, including product registration accompanied by approval of a new or existing active constituent when 2 or more modules are part of the assessment, and requires a project plan to be developed via pre-application assistance.
Item 5/6
Item 5 or 6 applications for registration of new products with existing active constituents which are similar or closely similar respectively to a reference product can also incorporate an application for approval of a new source of an existing active constituent complying with a monograph in the BP, Ph Eur or USP. As Items 5 and 6 have fixed fees and timeframes, there is no additional fee or timeframe associated with the approval of the active.
Item 10
Item 10 is a modular application item for registration of a new product containing existing active constituents. Item 10 applications can also incorporate applications for approval of new sources of existing active constituents. In that case, an additional Chemistry 5 module will be charged for each pharmacopoeia active, and an additional Chemistry 3 module will be charged for each non-pharmacopoeia active.
For further questions regarding specific scenarios where the above guidance does not provide an answer, you may wish to submit an application for pre-application assistance for advice on the most appropriate item and modules for your proposed application.