Earlier this year the APVMA released new risk assessment Module Descriptors required for new applications for Agriculture and Veterinary chemicals for applications received after 1 February 2023. The new document can now be reviewed to understand better how the changes will affect your registration. While the APVMA is still preparing updates to the website according to new changes, this document will guide industry stakeholders in how to prepare for new applications. Many changes are already present on the website.
The main changes for agriculture chemicals include:
- A new ‘Health’ module combining the previously labelled Toxicity and Work Health Safety
- Two new module options for Chemistry with reduced fees and timeframes
- One new module option for Environment with reduced fees and timeframes
- Changes to Residues including two new modules
- Removal of the module numbers, now to be known as more meaningful names
One positive change is providing possible timeframe and fee reductions for applications where appropriate overseas assessments are submitted, along with supporting data, as long as the holder engages the APVMA with a Pre-application Assistance (PAA) meeting and project plan.
Finalisation of product registration now may be faster for some products. In some cases, the finalisation stage may take only 2 months, rather than the previous standard 3 months.
Changes to Chemistry Modules
If a product falls under the two new Chemistry modules (Chemistry 4 or Chemistry 5) then the fees may be reduced from previous chemistry module requirements. These apply to some situations where a product is extending a shelf-life, changed storage conditions, or approval of a new source of active where there is a standard or monograph. The timeframes are also reduced from 6-13 months to a quicker 2-3 months.
Changes to Environment Modules
If a product falls under the new Environment module (Environment 4) then the fees may be reduced from previous environment module requirements. These apply to some situations where the only assessment is for new spray-drift reduction technology and/or deposition curve, or variation of registered products requiring specific spray-drift assessments. The timeframe for the new module is only 3 months (previous options were 4-13 months).
Changes to Residue Modules
If a product falls under the two new Residue modules (Residue 3 or Residue 5) then the fees may be reduced from previous residue module requirements. The new modules may provide an alternative to the previous modules 5.2 and 5.4 under certain situations, giving applicants faster timeframes and lower related fees.
New Health Module
There are 6 new health modules (Health 1 – 6) to replace the previous Toxicology and WHS modules. In short, these modules replace the following old modules:
|New Module||Replaces old module(s)|
|Health 1||Tox 3.1 and OHS 6.1 combined|
|Health 2||Tox 3.1 only|
|Health 3||Tox 3.2 and OHS 6.2 combined|
|Health 4||Tox 3.3 and OHS 6.3 combined|
|Health 5||Tox 3.3 OR OHS 6.3|
|Health 6||New module for approval of a new source of an approved Active considering novel impurities.|