This content is current only at the time of printing. This document was printed on 7 April 2020. A current copy is located at https://apvma.gov.au/taxonomy/term/17971
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I want to register a new product which 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 which contains a new active constituent is made via:
Item 1 – New product, new active constituent—full assessment required of the active constituent and product
Item 2 – New product, new active constituent—less than full assessment required of the active constituent and product
Item 27 – Timeshift application (requires PAA and an agreed project plan).
Which application form do you need?
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, worker health and safety, environment and efficacy and safety. It may also include trade and special data modules, if applicable.
Applications involving less than full assessment (Item 2) include where the active constituent is:
- a biological
- currently used in domestic or industrial chemicals
- an adjuvant for use with other agricultural products
- proposed for uses (excluding vertebrate poisons) only in:
- a non-food crop
- domestically in the home, home garden or a swimming pool or spa
- buildings not used in animal production (for example, warehouses, offices, or glasshouses).
Alternatively, a timeshift application (Item 27) may apply which allows flexibility for the staged submission of data to support an application. This can streamline an application with longer assessments such as toxicology and environment by commencing those assessments before the data for efficacy and crop safety are submitted for assessment. Timeshift applications can also be used to facilitate global joint reviews (GJRs) and the use of overseas assessments.
Note: The APVMA encourages the submission of international assessments to support applications for the approval of new active constituents and registration of new products. The submission of international assessments and underlying data may reduce assessment timeframes for major applications.
Pre-application assistance is available to give applicants advice on the requirements of an application before submission.