This content is current only at the time of printing. This document was printed on 8 September 2020. A current copy is located at http://www.gitygostar.com/node/32901
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I want to submit a timeshift application
A timeshift application provides for the staged submission of supporting data packages allowing commencement of longer assessments (such as toxicology and environment) while other supporting data packages (such as efficacy and crop safety) are being completed.
Timeshift applications can be used for applications involving multiple assessment modules including:
- approval of a new active constituent
- registration of a product that contains a new active constituent
- registration of a product that contains an approved active constituent or variation of a registered product where two or more technical assessment modules (Items 2 to 10 of the module types) apply
- where there is a previously approved active constituent not in any currently registered products
- global joint reviews (GJRs)
- to facilitate the use of overseas assessments.
The application is assessed according to a project plan which is developed and agreed between the applicant and the APVMA as part of pre-application assistance (PAA) tier 2 or tier 3. A timeshift application cannot be submitted without an agreed project plan.
The agreed project plan sets out the sequence for the submission of each data package (chemistry and manufacture, toxicology, WHS, residues, environment, efficacy, crop safety, trade—including non-food and any special data if required) and timeframe for conducting the necessary modular assessments.
The Agricultural and Veterinary Chemicals (Administration) Act establishes the APVMA as an independent statutory authority of the Commonwealth responsible for the regulation and control of agvet chemicals in Australia up to the point of retail sale. This Act contains all the internal details of the establishment of and the functions and powers of the APVMA. It also contains provisions controlling the import and export of agvet chemicals.
The Agricultural and Veterinary Chemicals Act contains the constitutional and other legal provisions that enable the Agvet Code to have effect.
The Agricultural and Veterinary Chemicals Code Act, among other things, contains the detailed provisions allowing the APVMA to evaluate, approve or register and review active constituents and agricultural and veterinary chemical products (and their associated labels); and to issue permits and to license the manufacture of chemical products. It also contains provisions for controls to regulate the supply of chemical products; and provisions ensuring compliance with, and for the enforcement of, the code.
The Agricultural and Veterinary Chemicals Code Regulations 1995 prescribe detailed provisions of the Agvet Code.
The Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument 2014 sets out the information that must be contained in, or accompany an, application under the Agvet Code.
Section 6A of the Agricultural and Veterinary Chemicals Code Act states that the APVMA may make guidelines. The APVMA has a number of guidelines which fall under this, for example:
In addressing the criteria, the applicant may provide information, or valid scientific argument to address a specific criterion. The following sections of the Agvet code provide definitions for meeting the criteria:
- Safety (section 5A).
An active constituent or chemical product meets the safety criteria if use of the constituent or product, in accordance with any instructions approved, or to be approved, by the APVMA for the constituent or product or contained in an established standard:
a) is not, or would not be, an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and
b) is not, or would not be, likely to have an effect that is harmful to human beings; and
c) is not, or would not be, likely to have an unintended effect that is harmful to animals, plants or things or to the environment.
To satisfy the section 5A criteria, the APVMA considers chemistry and manufacture, toxicology (including poison scheduling), residues, worker health and safety, environment and target safety.
- Efficacy (section 5B).
A chemical product meets the efficacy criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA for the product or contained in an established standard, is, or would be, effective according to criteria determined by the APVMA by legislative instrument.
- Trade (section 5C)
A chemical product meets the trade criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA or contained in an established standard, does not, or would not, unduly prejudice trade or commerce between Australia and places outside Australia.
- Labelling (section 5D)
In approving a label for a container for chemical products, the APVMA must be satisfied that the label contains adequate instructions. This allows the APVMA to ensure that the risks of using the agvet chemical product are adequately mitigated through appropriate instructions.
The APVMA’s Agricultural labelling code and Veterinary labelling code also contain further labelling requirements that ensure a standard layout, legibility and further help in mitigating the risk of using agvet chemical products when used in accordance with the label instructions.
Section 8A of the Agvet Code provides the definition of meets the application requirements.
Section 8AG of the Agvet Regulations includes additional requirements for timeshift applications.
Parts 2 and 4 of the Agricultural and Veterinary Chemicals Code (Application Requirements) Instrument sets out the information that must be contained in, or accompany an, application under the Agvet Code.
6A of the Agvet Code states that the APVMA may make guidelines etc.
The APVMA has designed guidelines to help inform the APVMA and applicants as to the modules, data and information that will apply for different types of applications. The Guidelines are not the law. The APVMA will have regard to them, but from time to time may depart from them when determining the modules and supporting data and information necessary for a particular application. The APVMA has a number of guidelines which describe:
Applications may be withdrawn
Section 8D of the Agvet Code states that at any time after the application is made and before it is determined, the applicant may withdraw it by giving the APVMA written notice of the withdrawal signed by the applicant.
A timeshift application is defined in section 3BA of the Agvet Regs as:
(1)?An application is a timeshift application if:
- (a) it is covered by subregulation (2); and
- (b)?the applicant and the APVMA have agreed that it will be assessed in accordance with assessment periods set out in a project plan for the application agreed to by the applicant and the APVMA.
(2) An application is covered by this subregulation if:
- (a) the application is of a kind described in column 1 of Item 1, 2, 3, 4, 5, 10, 11, 14 or 15 of the table in clause 2.1 of Schedule 6; and
- (b) if the application is of a kind described in column 1 of Item 10 or 14—the APVMA has determined that at least 2 of the modules at Items 2 to 10 of the table in Schedule 7 are necessary for the application.
Note: the table in clause 2.1 of Schedule 6 sets out the assessment periods and fees applicable to applications. For timeshift applications, see Item 27 of the table.
Timeframe and fees
The modules required for a timeshift application will be agreed between the applicant and the APVMA during PAA and documented in the agreed project plan for the application.
More information about module types and fees can be found on our website.
If the applicant is issued with a requirement to provide additional information under section 159, or the applicant misses an agreed data submission deadline, the APVMA may revise the project plan to reflect any delays and/or the extended assessment period.