Agricultural Chemical Product Registration
Conditions of Registration are applied at the time the APVMA registers an agricultural chemical product. The conditions set out the registrant's responsibilities for ensuring the quality of agricultural active constituents.
Under the conditions the product registrant must ensure the active constituent is sourced from an APVMA manufacturing site listed in the Record of Approved Active Constituents.
The conditions also require that the active constituents meet the relevant APVMA standards. Among other things, these standards set out the purity and the maximum concentration for specified impurities.
The product registrant or a nominated third party must keep records for each batch of active constituent used in the registered product, including batch analysis records, and the name and address of the manufacturing site for that batch of active constituent. The records must be made available to the APVMA within 10 days of any request and must be kept for two years after the manufacture of the agricultural chemical product.
The APVMA will consider requests for variations to the standard conditions on a case-by case basis. New applicants or existing registrants must provide additional information to support any proposals for alternative conditions.
Certain active constituents might be excluded from the requirements of APVMA approval where they have not been primarily developed for agricultural use. In such cases where the chemical product only contains active constituents for which a standard doesn't exist, the standard conditions will not be applied.
Where an active constituent is contained in a manufacturing concentrate and a standard for the manufacturing concentrate does not exist, it is the responsibility of the registrant to establish compliance with APVMA standards for active constituents.
See the Standard conditions of registration.
Variations to Conditions of Registration
The APVMA must be satisfied that the conditions of product registration, related to analysis results and record keeping are appropriate for compliance purposes. The APVMA must also be satisfied that the the analysis results ensure compliance with the APVMA Standard. The APVMA believes that repeated, individual batch analysis is the optimal mechanism for this.
Industry members have suggested that there are numerous alternatives to batch analysis that could be used e.g. skip-lot testing under a quality assurance scheme. If applicants/registrants propose that alternative conditions could apply, then applicants will need to provide information that allows the APVMA to be satisfied that such alternatives are equivalent to repeated, individual batch analysis.
Additional information may include matters such as:
- reference to the QA/QC program of the manufacturer of an active constituent that has been previously considered by the APVMA on application for approval of an active constituent or approval of an active constituent from a different site of manufacture (eg in cases where impurities are not expected to occur because of a unique manufacturing process);
- verification of incoming material (active constituent) against the APVMA Standard under a QA/QC program for agricultural chemical products (eg skip lot testing of active constituent where trend analysis demonstrates appropriate quality control);
- relevant scientific argument about the proposed program of batch analysis of active constituent that would be equivalent to individual, repeated batch analysis against the APVMA Standard.
When individual, repeated batch analysis is undertaken, compliance action can be considered on a batch-by-batch basis. In the absence of individual, repeated batch analysis, the APVMA may need to take compliance action on a larger scale eg. involving all product (rather than batch-by-batch).
The APVMA does not intend auditing QA/QC systems as part of the compliance program.
More Information
Please read more information about Active Constituents.