This content is current only at the time of printing. This document was printed on 8 September 2020. A current copy is located at http://www.gitygostar.com/node/18586
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Changes to products and actives
After an active constituent is approved or a chemical product is registered there are a number of ways to make changes depending on the type of information you are changing and whether it is relevant. These include:
- making an application to vary a relevant particular or condition
- notifying the APVMA of minor changes, or
- reporting relevant information.
Making a variation application or notifying a minor change
If the change is to a relevant particular or condition for a product or active constituent, or to notify the APVMA of a minor change, the application is made through APVMA online services. The type of application is determined by the using the decision tree which leads the user through a series of questions to determine whether the application is made as a notifiable variation of a minor change or an application under a particular ‘item’.
For information about what to include in specific product variation applications see the data guidelines. Relevant particulars for products and active constituents are set out at regulations 16 and 15 of the Agricultural and Veterinary Chemicals Code Regulations 1995 (Agvet Code Regulations) respectively.
Reporting relevant information
Holders of active constituent approvals, registration holders and permit holders must provide the APVMA with any relevant information they become aware of that shows the safety, trade or efficacy criteria may no longer be met, or that contradicts information held by the APVMA for the active constituent or product.