This content is current only at the time of printing. This document was printed on 29 April 2017. A current copy is located at http://apvma.gov.au/node/967
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1. What is this guideline about?
- This guideline is made pursuant to section 6A of the Agvet Code.
- The purpose of this guideline is to set out our principles and processes in relation to performing our functions and exercising our powers relating to recategorising applications under regulation 70B of the Agvet Code Regulations.
- It covers the circumstances in which we will recategorise an application.
- The provisions of the Agvet Code and the Agvet Code Regulations covered by this guideline are outlined in the annexure to this guideline.
- This guideline commences on 1 July 2014.
2. When will we recategorise an application?
- We will recategorise an application to ensure that:
- the correct level of assessment is applied
- the correct fees are charged, and
- the correct assessment period is allocated for the processing of the application.
- We will recategorise an application only where the information provided by the applicant is sufficient for us to assess the recategorised application. We will not recategorise an application where we would need further information to assess the recategorised application.
- Any recategorisation of an application must be consistent with the Agvet Code and the Agvet Code Regulations.
- An application for registration of a chemical product containing an approved active constituent is lodged. In accordance with the information provided with the application, the application is initially categorised as an item 6 application (see the table in Part 2 of Schedule 6 to the Agvet Code Regulations), on the basis that we consider (based on the applicant’s application) that the proposed product may be closely similar to a registered product. During assessment of the application, we determine that the product is similar to the registered product but not closely similar, and that therefore the application is more correctly categorised as an item 5 application. The applicant has only provided chemistry and manufacture data, but we also require efficacy or target species safety data to assess an item 5 application. Since efficacy or target species data was not provided with the application, we will not recategorise the application.
3. Annexure—relevant legal provisions
- Different applications made under the Agvet Code may require different assessments for us to be satisfied about the safety, efficacy, trade or labelling criteria set out in the Agvet Code (as the case may be). The fee structure and assessment timeframes in the Agvet Code Regulations reflect the different assessments that may be required.
- After certain applications are made under the Agvet Code, we categorise the application, based on the information provided with the application, in line with a particular item of the table in Part 2 of Schedule 6 to the Agvet Code Regulations. Where required, the application is also assigned particular modules, levels or types mentioned in Schedule 7 to the Agvet Code Regulations. This categorisation is based on the level of assessment we consider is required for the application to be determined in accordance with the requirements of the Agvet Code and the Agvet Code Regulations.
- The application fee is payable, in part, at the time the application is made. The balance is payable within 28 days of notice being given to the applicant in relation to the application (and our initial categorisation of the application). This is because the application fee is prescribed for the making of the application, not for the completion of the assessment of the application.
- After payment of the relevant fee and preliminary assessment of the application, and prior to determination of the application, we may recategorise the application on the basis that:
- the application is more correctly categorised as an application of a kind mentioned in a different item of the table in Part 2 of Schedule 6 to the Agvet Code Regulations, or
- different modules, levels and types mentioned in Schedule 7 to the Agvet Code Regulations are necessary for the application.
- We must give the applicant notice of the recategorised application. As a consequence of the recategorisation, different application fees may apply to the recategorised application.
Note: Division 9.2 and Schedules 6 and 7 of the Agvet Code Regulations deal with fees in respect of applications. Regulation 70B of the Agvet Code Regulations deals with recategorised applications.