APVMA: Tailored guidance for applicants

2020-03-27

We’re improving our guidance material, tailoring it 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.

The following tailored guidance is available now. At the end of the process you’ll be able to start an application:

New product registrations

I want to register a new product with an existing active or new combination of approved actives

I want to register a new product which contains a new active constituent

I want to register a product that is based on an existing registered reference product

I want to register a product that is the same as a reference product.

Additional labels for a registered product

I want an additional marketing name for my existing registered product.

Variations to registered products

I want to vary my product to amend a restraint, contraindication, precaution or side effect statement (vet products only)—New

I want to vary my product to alter the shelf life/expiry date, in-use shelf life and/or storage conditions—New

I want to vary a re-entry or handling instruction for my product

I want to vary a withholding period and/or export interval

I want to vary my product to add a new crop, animal species or situation

I want to vary the sites of manufacture

I want to vary a product pack size.

Timeshift applications

I want to submit a timeshift application.

The tailored guidance materials are an alternative pathway to the existing decision tree, which is still available.

We’ll be gradually making more tailored guidance available for other common types of applications.

22 October 2019

APVMA, 27 March 2020
; https://apvma.gov.au/node/27441