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Purpose of this manual
This manual is intended to provide stakeholders, including industry and the general public, with a general description of the assessment approaches and practices that the APVMA applies to the evaluation of chemistry and manufacture data. The chemistry and manufacture data is evaluated as part of the APVMA determination whether the safety and efficacy criteria for the approval of active constituents and the registration of pesticide and veterinary medicine products have been met.
This manual provides more detail about the APVMA risk assessment approach and is complementary to the information provided about the APVMA approach to the safeguarding aspects of our science, risk management and regulation according to risk.
For prospective applicants, this manual should be considered in conjunction with the APVMA data guidelines for chemistry and manufacture.
Chemistry and manufacture data is evaluated and assessed to confirm the identity of the compounds contained in actives or products and to confirm the specifications for compounds or products including specifications for any impurities likely to be present. The assessment should also confirm that the manufacturing processes are under control and will produce the compounds or product formulations as described and within specifications—particularly those for any toxicologically significant impurities. For products, and for the first assessment of an active constituent an assessment of the stability of the product (active) is also conducted. The measurement techniques need to be validated to ensure they are fit for purpose to confirm that they accurately represent the compounds present and that any statistical analysis used to interpret that data is also appropriate. The chemistry data also provides physicochemical parameters useful to the human health, residues and dietary risk and environmental risk assessments of an active or a product.
This manual does not apply to immunological type active constituents in veterinary chemical products, for example vaccines.
This document applies to biological pesticides such as Bacillus thuringiensis and naturally derived actives or botanicals such as tea tree oil.
The assessment of Listed Chemical Products—does not require evaluation of data and consequently is outside the scope of this document.
It is expected that by using this document the user would be able to:
- determine that the chemistry and manufacture data generated to support an active constituent approval or a chemical product registration is fit for its intended purpose (ie likely to result in the granting of the approval of the active and/or registration of a chemical product application), and
- highlight to the applicant prior to the submission of an application the likely gaps in the chemistry and manufacture data that might require further data, justification or clarification or that might be expected to result in additional measures that the applicant may take to address any data gaps.
Throughout this manual it will be apparent that there are differences in the data typically required for, and the APVMA assessment processes for, pesticide active constituents and chemical products compared to veterinary medicine active constituents and chemical products. This approach reflects the differences contained in the Agvet Code and the different approaches adopted as international best practice for pesticide active constituents and chemical products, and for veterinary medicine active constituents and chemical products.