This content is current only at the time of printing. This document was printed on 21 September 2018. A current copy is located at https://apvma.gov.au/node/27681
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Improved application pathways
We’re developing guidance material tailored to the information you need to lodge the right application, with the right data and supporting evidence to meet APVMA criteria.
Whether you’re registering a new product or making a variation, you’ll have access to current and clear guidance for that application type, before you enter our online services portal.
By improving our guidance material for applicants, we aim to make the registration process smoother and more efficient for the most common application types. This approach provides the relevant guidance up front, so you can more easily submit an accurate and quality application.
The tailored guidance provides an alternative pathway to the existing decision tree, which will still remain available.
This project is one of our business improvement projects funded through the Australian Government’s Agricultural Competitiveness White Paper, to improve access to agricultural and veterinary chemicals. It also addresses a key recommendation from the Australian National Audit Office 2017 report, Pesticide and veterinary medicine regulatory reform.
We’ve developed tailored guidance for applications to:
- vary a product pack size
- vary the sites of manufacture
- vary my product to add a new crop, animal, species or situation
- register a product that is the same as a reference product.
We’ll be gradually providing more guidance materials for other common application types, including:
I want to vary my product
- to add a new use within an existing crop, animal, species or situation
- to make a change to the formulation
- to make a change to the shelf life or expiry date
- to include a new dose rate/frequency of application
- to include new application methods/routes of administration/equipment
- to establish a new trade statement
- to alter a contraindication or side effects statement
- to alter the re-entry or handling instructions.
I want to register a new product which
- is a combination of existing active constituents
- has a new formulation type or dose form
- has a brand new active constituent
- where the assessment will be conducted as a timeshift.