This content is current only at the time of printing. This document was printed on 19 September 2020. A current copy is located at http://www.xlg888.com/node/960
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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 scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (Cth) (Agvet Code).
- The purpose of this guideline is to set out the APVMA’s principles and processes in relation to performing the APVMA’s functions and exercising its powers relating to altering applications made under sections 10, 26B, 27, 48 and 110 of the Agvet Code.
- This guideline covers the circumstances in which the APVMA will consider altering applications, and how the APVMA? will obtain consent.
- The provisions of the Agvet Code and the Agricultural and Veterinary Chemicals Code Regulations 1995 (Cth) (Agvet Code Regulations) covered by this guideline are outlined in the annexure to this guideline.
- This guideline commences on 20 July 2020.
2. What are the circumstances in which we will consider altering an application?
- The APVMA expect applicants or holders to lodge an application that contains or is accompanied by all relevant information such that the application ‘meets the application requirements’ (see section 8A).
- The APVMA may ask an applicant to consent to the alteration of an application where:
- the alteration is necessary for the APVMA to continue to assess an application (rather than propose to refuse it); and
- it would be more efficient to alter the application than to refuse the application and have the applicant or holder resubmit the application.
- The APVMA will take into account the following considerations in determining whether altering an application might be efficient:
- whether the APVMA has completed work that the APVMA will be required to repeat if the application were not altered and consequently refused and then resubmitted by the applicant or holder;
- the extent and complexity of the alteration required
- the degree to which the proposed alteration would affect the time available to the APVMA to determine the application; and
- the APVMA resourcing capacity (and the capacity of the bodies that we consult with in assessing applications) and our other regulatory responsibilities.
- The APVMA is not required to alter an application to correct a deficiency.
Any amendment of an application must be consistent with the Agvet Code and the Agvet Code Regulations.
- An application has been made that contains typographical or other minor errors or omissions. The APVMA? may seek to alter the application to correct those errors or omissions.
- An application has been made under Item 15 for registration of a novel active constituent. The application assessment process has been proceeding for 11 out of the maximum 14 months. Some components of the assessment have already been completed, and other components are almost finished. A problem is discovered in the application which could be remedied by altering the application without affecting the APVMA’s ability to complete the assessment of the application within the timeframe. In this case, the APVMA may seek to alter the application and continue the assessment rather than give notice to the applicant under section 8S of the Agvet Code of the APVMA’s? proposal to refuse the application (and potentially have the applicant or holder resubmit the application).
3. Obtaining consent—when and how?
- If the APVMA decides that an application should be altered (in accordance with this guideline), the APVMA? will make contact with the applicant or the holder to discuss the reasons for proposing to alter the application, and to seek their consent to the alteration.
An email exchange between the APVMA and the applicant or holder confirming the terms of the alteration may satisfy the requirements for written consent.
- After submitting an application for registration of a chemical product (and before its determination), the applicant becomes aware of new evidence that says one of the proposed uses of the product is unsafe. After the applicant notifies the APVMA? of that new information, as required by section 160A of the Agvet Code, the APVMA? will discuss with the applicant or holder the possible alteration of the application to remove the unsafe proposed use. The applicant agrees to the alteration and the APVMA? exchanges emails with the applicant in which the terms of the alteration and the applicant’s consent to it are clearly specified.
4. Annexure—relevant legal provisions
- The APVMA has the power to alter certain applications made under the Agvet Code. Such alterations may only be made with the written consent of the applicant or holder.
- The APVMA has the power to alter the following applications:
- applications for the approval of an active constituent for a proposed or existing chemical product, for registration of a chemical product, or for approval of a label for containers for a chemical product (section 10(1));
- applications for the variation of a relevant particular prescribed by legislative instrument of an approval or registration (section 26B(1));
- applications for the variation of the relevant particulars or conditions of an active constituent, a chemical product, or a label for a chemical product (section 27)(1) and (2));
- applications for the renewal (or further renewal) of the registration of a chemical product (section 48(1));
- e. applications for a permit (section 110).
Some applications can only be altered after they have passed preliminary assessment.
Note: Section 11(4) of the Agvet Code deals with altering applications for approval or registration. Sections 26B(3) and 28(4) deal with altering applications for variation. Section 48(5) deals with altering applications for renewal. Section 110A(5) deals with altering applications for a permit.