I want to register a new product that contains a new active constituent
For a new agvet chemical product that contains a new active constituent, the APVMA must approve both the active constituent and register the product.
Registering a new product that contains a new active constituent is made via:
I want to register a new product with an existing active or new combination of approved actives
Registering a new agvet chemical product containing an existing active may be assessed under:
- Item 10 – New product – modular assessment.
Common application types submitted under Item 10 include:
Gazette No 24, 28 November 2023
Contents
- Agricultural chemical products and approved labels – 1
- Veterinary chemical products and approved labels – 16
- Approved active constituents – 21
- Amendments to the APVMA MRL Standard – 29
- Proposal to amend Schedule 20 in the Australian New Zealand Food Standards Code – 30
- Agvet chemical voluntary recall: Macspred Glymac™ Bi Dri 800 Herbicide – 35
- Agvet chemical voluntary recall: Treidlia Auslepto Vaccine – 36
- Notice of cancellation at the request of the holder – 37
Chemical product
For a chemical product, the Australian Pesticides and Veterinary Medicines Authority (APVMA) must be satisfied that the product meets the safety criteria, the efficacy criteria, the trade criteria, and the labelling criteria.
Labelling Codes
The Agricultural and Veterinary Chemicals Code (Agvet Code), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 and the Agricultural and Veterinary Code Regulations 1995 (Agvet Code Regulations) requires that all agricultural and veterinary chemical (agvet) products supplied to the marketplace must have a label attached to the container. In addition, the Australian Pesticides and Veterinary Medicines Authority (APVMA) cannot register an agvet product without also approving a label for containers for the product.