New tailored guidance—changes to product formulations

We’ve published new tailored guidance to assist with applications to vary a product to make a change to the product’s formulation, for both agricultural and veterinary products.

Changes to the formulation of a product may be required for a variety of reasons, including the availability of excipients or changes to the purity of the source of active used in the formulation. Our new tailored guidance provides three registration pathways depending on the change required, and at the end of each pathway you’ll be redirected to our Online Services Portal to start your application.

Designed to make the registration process easier and more efficient, our tailored guidance pathways provide the information you need to lodge the right application, with the right data and supporting evidence to meet APVMA criteria.

Learn more about tailored guidance for applicants, and view the complete list of pathways available.

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URL

http://apvma.gov.au/node/70446
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