This content is current only at the time of printing. This document was printed on 11 May 2021. A current copy is located at https://apvma.gov.au/node/1047
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Chemistry and manufacture requirements for variation of a registered agricultural chemical product
Applicants may apply for the following variations to the particulars or conditions of registration of a registered agricultural chemical product:
- changes to the formulation
- changes to the product specifications (with or without changes in the formulation process)
- changes to specifications of the non-active constituents
- extension of shelf life
- extension of in-use shelf life
- change to storage temperature conditions
- changes to pack size
- a non-statutory condition relating to packaging material and/or closure systems.
1. General information
The registration holder is responsible for notifying the APVMA of any proposed changes to the formulation of the product and the formulation process of the product. Similarly, the registration holder must apply to the APVMA to make changes to the storage conditions, shelf life (where applicable) and pack sizes of products in the marketplace. We assess these proposed changes to determine whether the change has any impact on the safety of the product and whether the product still satisfies the statutory criteria for safety.
2. Satisfying the safety criteria for a variation to a registered agricultural chemical product
Registration holders may satisfy us of the safety statutory criteria through provision of any of the following, either singly or in combination:
- data that allow us to be satisfied of the statutory criterion
- valid and relevant scientific argument that satisfies us of the statutory criterion
- reference to previously submitted data that are directly relevant to the current application
- reference to directly relevant overseas assessments and decisions.
Further information about using each of these approaches is available in the guideline, Putting your application together—approval, registration and variation.
2.1. Providing data to satisfy the safety criteria
You should provide the following information with each application for variation to particulars or conditions of registration of a product, where applicable:
- product details
- distinguishing name
- formulation type
- physical and chemical properties
- details of formulator and formulation site
- formulation composition
- any changes to the formulation process and quality control steps
- batch analysis data
- stability data
- full details of the analytical method(s) used
- appropriate validation data for the analytical method(s).
2.2. Providing valid and relevant scientific argument
You may use valid and relevant scientific argument to satisfy us of the safety criteria for a variation to a registered agricultural chemical product. Argument may also be used in conjunction with data.
2.3. Reference to previously-submitted data
If the manufacturing process or the analytical methods have been assessed and accepted by us in a previous application, you may refer to the data provided in that application.
A suitable reference should include the product registration number, the application number and the data reference number. We reserve the right to request that you resubmit any or all the referenced data you previously submitted.
2.4. Using overseas data assessments and decisions
We may accept data that have been generated overseas in support of a variation to a registered product. In using overseas data and decisions, we will consider:
- the similarity of the Australian and overseas products
- the relevance of the data to Australian climatic and environmental conditions, agricultural systems
- any differences between the approaches and legislative responsibilities of the Australian and the overseas regulatory decision-making authority.
3. Data list
You should provide a data list, irrespective of whether the data are eligible for limitation on use.
4. Template for the dossier to support an application for variation
The dossier you submit to support an application for variation of the particulars or conditions of a registered agricultural chemical product should contain the following content sections:
- Table of contents
- Overall summary
- Distinguishing product name
- Formulator and formulation plant details
- Formulation type
- Formulation composition
- Common or chemical names of the constituents
- Chemical Abstracts Service registry number (if available)
- Concentration of all active and non-active constituents in the formulation
- Reference to quality standards
- Purpose in the formulation of the non-active constituents
- Batch records
- Formulation process and quality control
- Cleaning and validation of equipment—this should include a description of the method and specifications for cleaning of equipment between different batches that contain different active constituents, non-active constituents or formulation type.
- Physical and chemical properties of the product
- Potential for the formation of impurities of toxicological concern
- Product specifications
- Batch analysis data
- Stability data
- Accelerated testing
- Real-time testing
- Cold-stability testing for liquid products
- Analytical methods
- Description of analytical methods
- Purity of the reference standards
- Chromatograms of the sample and reference standard
- Worked examples of the calculations
- Validation data
- Recovery (accuracy)
- Limit of detection (LOD) and limit of quantitation (LOQ) for relevant impurities
- Data list.