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…A full assessment (Item 1) involves a comprehensive assessment of data for both the active constituent/s and the proposed chemical product is required for chemistry and manufacture, toxicology, poisons scheduling, residues and trade,…
A full assessment (Item 1) involves a comprehensive assessment of data for both the active constituent/s and the proposed chemical product is required for chemistry and manufacture, toxicology, poisons scheduling, residues and trade,…
Most applications to register new veterinary chemical products containing a new active constituent are submitted as a less than full assessment (Item 2) because one or more modules can be assessed below level 1. Examples include products…
Applications to register a new product based on that product being similar or closely similar to a registered reference product can be made via one of the following item numbers:
Item 5…
- Legislation
A registered chemical product can be marketed under more than one brand name. An application can be made for the approval of a label for a container for a registered chemical product under Schedule 6 Part 2 Item 10A…
- Legislation
A registered chemical product can be marketed under more than one brand name. An application can be made for the approval of a label for a container for a registered chemical product under Schedule 6 Part 2 Item 10A of the Agvet…
For registration, veterinary chemical products must be shown to be safe and effective when used in accordance with any approved directions for use. Product labels must adequately reflect these directions, including restraints, contraindications,…
- Legislation Framework
The Agricultural and Veterinary Chemicals (Administration) Act 1992 establishes the APVMA as an independent statutory authority of the Commonwealth, responsible for the regulation and…
- Legislation Framework
The Agricultural and Veterinary Chemicals (Administration) Act 1992 establishes the APVMA as an independent statutory authority of the Commonwealth, responsible for the regulation and…