The Australian Pesticides and Veterinary Medicines Authority (APVMA) offers a range of assistance and guidance, including:
General assistance
The APVMA can provide assistance to clarify general administrative requirements, information on our website and APVMA Online Services Portal.
For general assistance please contact us.
Pre-application assistance
The APVMA may provide pre-application assistance. This assistance gives applicants the opportunity to reduce the uncertainty associated with making an application.
Pre-application assistance can be used for any type of application and can include advice about:
- whether an application for registration is required
- types of information required to address the statutory criteria
- types of supporting data appropriate to the application
- types of trials needed to generate appropriate data
- the use of overseas data and/or assessments
- suitability of a trial protocol
- project plans.
Further information on pre-application assistance is available on apvma.gov.au.
Technical assessment
The APMVA may provide a technical assessment of data – also known as an Item 25 application. A technical assessment involves the APVMA assessing data which may be used to support a future application for registration of a chemical product, variation to relevant particulars associated with approval or registration, or approval of an active constituent, and may include consideration of overseas data. Data may be submitted to determine its relevance to the safety, efficacy and trade criteria.
The fee and assessment period for your application is prescribed in Item 25 of Schedule 6 of the Agvet Code Regulations. The fee for this application type is modular, which means fees and assessment period will depend on which assessment modules are relevant to your application. All Item 25 applications require the Finalisation 3 module.
Applications for technical assessment can be made through our Online Services Portal.