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:

  • Item 1 – New product, new active constituent – full assessment required of the active constituent and product. Fixed fee and timeframe. A complete data package is required to be submitted with your application.
  • Item 2 – New product, new active constituent – less than full assessment required of the active constituent and product. Variable, modular fee and timeframe.  A complete data package is required to be submitted with your application.
  • Item 27 – Modular, timeshift application allowing full or reduced assessments of active constituents and products. Variable, modular fee and timeframe. Staged submission of supporting data packages according to an agreed project plan. Requires pre-application assistance.

Which application form do you need?

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