I want to register a product that is the same as a reference product
Registering a new product that is the same as a registered reference product is also known as a ‘repack’.
The new product must be the same formulation with the same ingredients as the reference product, be in the same containers and be manufactured by a manufacturer of the reference product. The use pattern, label claims and use instructions for the new product must be the same as those of the reference product. The legislated definition of 'the same' can be found in the legislation section of the application guidance provided below.
I want to register a veterinary product that is based on an existing registered reference product and is closely similar and data is not required (Item 7)
Schedule 6 of the Agvet Code Regulations provides statutory definitions of when a proposed product is similar or closely similar to a reference product. To determine the appropriate Item number, you need to first establish whether your product meets the statutory definition of similar or closely similar in relation to your nominated reference product.
I want to register a product that is based on an existing registered reference product
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: