This content is current only at the time of printing. This document was printed on 23 June 2021. A current copy is located at http://www.plural-consulting.com/node/267
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The legislation requires us to publish certain information to support the transparency of our decisions. We do this by publishing application summaries and information about our decisions on our website or in the Australian Pesticides and Veterinary Medicines Authority (APVMA) Gazette.
Application summaries – early disclosure
For most applications for an active constituent or agvet chemical product, we publish a ‘summary of application’ on our website shortly after the application has passed preliminary assessment. This allows us to publicly acknowledge that an application has been made, while publishing the information that has been submitted to support the application.
One of the benefits of this approach is that other government authorities that have functions within our legislation – such as Food Standards Australia New Zealand and the Office of the Gene Technology Regulator – are able to disclose the existence of an application to allow other related regulatory actions to occur.
The type of applications to which early disclosure applies include those for new active constituents, products, labels, and applications involving variations to products and labels, where the variation involves a change to the use, supply or disposal of the product.
- Applicant name.
- Application number.
- Active constituent name and number.
- Product name and number.
- Application purpose and description of active constituent or product use.
- The data list that was provided with the application.
- The relevant reference active constituent and/or product names and numbers.
Publication of information on manufacturing licences
When we issue a new licence, vary a current licence, or suspend or cancel a licence, we publish certain information in the Gazette. The information published may include the following details:
- The licence number, company name, address, product types, step(s) of manufacture and issue date of new/amended licences.
- A brief description of licence changes.
- The date of licence cancellation or suspension, including legislative reason.
- The date of revocation of licence, cancellation or suspension.
Publication on approval or variation of an active constituent or registration
When the APVMA grants an application for approval or variation of an active constituent or registration, we publish certain information in the Gazette or on our website. The information published may include a combination of the following details:
- The constituent, product or label that has been approved or registered and the date of the approval or registration.
- A brief statement about the conditions of the approval or registration that directly regulate the use of the constituent or product.
- The relevant particulars or conditions that have been varied and the date of the variation.
- A brief statement of the nature of, and reasons for, the variation.
- The name of the applicant for the approval, registration or variation.
- The application number.
- The name and distinguishing number of the active constituent.
- The name and distinguishing number of the chemical product.
- The distinguishing number of the label approval.
- The name of the active constituents of the chemical product.
- A short description of the application and its purpose, including the way in which the active constituent or chemical product is intended to be used.
- Brief details about the APVMA's decision.
- Information contained in the data list that has been afforded a limitation period.