This content is current only at the time of printing. This document was printed on 4 October 2022. A current copy is located at https://apvma.gov.au/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 Australian Pesticides and Veterinary Medicines Authority (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 the APVMA Online Services Portal. The type of application is determined by 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 or label approvals, registration holders and permit holders must provide the APVMA with any relevant information in relation to the constituent, product, label or permit as soon as they become aware of the information. Relevant information includes any information that shows the safety, efficacy, trade or labelling criteria may no longer be met or any information that contradicts information held by the APVMA for the active constituent, label, product or permit. Information on how to provide this information to APVMA is available on our website.