This content is current only at the time of printing. This document was printed on 13 September 2020. A current copy is located at http://www.xlg888.com/node/967
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1. What is this guideline about?
- This guideline is made pursuant to section 6A of the Agricultural and Veterinary Chemicals Code as scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (Cth) (Agvet Code).
- The purpose of this guideline is to set out our principles and processes in relation to performing the APVMA’s functions and exercising its powers relating to recategorising applications under regulation 70B of the Agricultural and Veterinary Chemicals Code Regulations 1995 (Cth) (Agvet Code Regulations).
- It covers the circumstances in which the APVMA 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 21 July 2020.
2. When will we recategorise an application?
- The APVMA may recategorise an application if the relevant application fee has been paid; and
- the APVMA determines, at any time after preliminary assessment of the application, that the application is more correctly categorised as an application of a kind mentioned in a different item of the table in clause 2.1 of Schedule 6 to the Agvet Code Regulations, (the recategorised item); or
- the APVMA consider, at any time after preliminary assessment of the application, that different modules, levels and types mentioned in Schedule 7 (the recategorised modules) are necessary for the application.
- The APVMA will recategorise an application to ensure that the correct item, module, level and type are applied.
- The APVMA may recategorise an application where the information provided by the applicant is sufficient for the APVMA to assess the recategorised application. The APVMA may also recategorise an application where the APVMA would need further information to assess the application and the APVMA has reasonable grounds to believe that the applicant already holds that information
- The APVMA will provide the applicant with a notice specifying the reasons for the proposed recategorisation and provide the applicant with an opportunity to respond before determining whether to recategorise.
- 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 the APVMA consider (based on the applicant’s application) that the proposed product may be closely similar to a registered product. During assessment of the application, the APVMA 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 the APVMA 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, the APVMA will not recategorise the application.
3. Annexure—relevant legal provisions
- After payment of the relevant fee and preliminary assessment of the application, and prior to determination of the application, the APVMA? may recategorise the application.
- Before recategorising the application, the APVMA? must provide the applicant with a notice outlining? proposed reasons for doing so, and providing the applicant with an opportunity to respond.
- As a consequence of the recategorisation, different application fees and assessment periods 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.