{"id":"F2015L01752","name":"Agricultural and Veterinary Chemicals Code (Pre-application Assistance Fee) Instrument 2015","slug":"agricultural-and-veterinary-chemicals-code-pre-application-assistance-fee-instrument-2015","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":93552,"registerId":"commonwealth-F2015L01752-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Agricultural and Veterinary Chemicals Code (Pre-application Assistance Fee) Instrument 2015","content":"![](image.001.png)\n\nAgricultural and Veterinary Chemicals Code (Pre‑application Assistance Fee) Instrument 2015\n\nAgricultural and Veterinary Chemicals Code Act 1994\n\nI, Kareena Arthy, Chief Executive Officer of the Australian Pesticides and Veterinary Medicines Authority, make this Instrument under subsection 164(1A) of the Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Agricultural and Veterinary Chemicals Code Act 1994.\n\nKareena Arthy\n\nChief Executive Officer\n\nDated this 2 November 2015\n\nPlaceholder 1 of 11\n\nPlaceholder 2 of 11\n\nPlaceholder 3 of 11\n\nPlaceholder 4 of 11\n\nPlaceholder 5 of 11\n\nPlaceholder 6 of 11\n\nPlaceholder 7 of 11\n\nPlaceholder 8 of 11\n\nPlaceholder 9 of 11\n\nPlaceholder 10 of 11\n\nPlaceholder 11 of 11\n\nPlaceholder\n\n(a) Name of Instrument\n\nThis Instrument is the Agricultural and Veterinary Chemicals Code (Pre-application Assistance Fee) Instrument 2015.\n\n(b) Commencement\n\nThis Instrument commences on the day after it is registered.\n\n(c) Revocation and transitional arrangements\n\n(1) This Instrument revokes the Agricultural and Veterinary Chemicals Code Regulations (Pre-application Assistance Fee) Instrument 2014 (the 2014 Instrument).\n\n(2) However, the 2014 Instrument continues to apply, and this Instrument does not apply, to applications for pre-application assistance made before the commencement of this Instrument.\n\n4 Overview\n\nThis Instrument sets out the criteria for working out which pre-application assistance fee applies under the Agricultural and Veterinary Chemicals Code Regulations 1995 (the Regulations) in a particular case.\n\nSubregulation 69B(3) of the Regulations prescribes the fee of $192.50 (GST inclusive) for one unit, or a part of one unit, that is payable in respect of pre-application assistance provided by the APVMA under regulation 8AT.\n\nSubregulation 69B(4) provides that a 2‑unit fee is payable in all cases; additional units attract fees pursuant to subregulation 69B(5). This Instrument sets out the criteria for working out which fees apply in a particular case.\n\n5 Pre-application assistance\n\nThe following table sets out the criteria for working out which pre-application assistance fee applies under regulation 69B of the Regulations in a particular case. Each application will fall within a tier and will include one or more elements of assistance. The fee is worked out by working out which tier applies to the application and which elements of assistance are involved.\n\n```html\n

Pre-application assistance tier

Elements of assistance

Fee under the Regulations

Tier 1

Administration by the APVMA

The 1‑unit fee ($192.50)

Preparation of a written response to the application, including research

The 2‑unit fee ($385)

Meeting between the applicant and the APVMA

The 2‑unit fee ($385)

Tier 2

Administration by the APVMA

The 1‑unit fee ($192.50)

Preparation of a written response to the application, including research

The 4‑unit fee ($770)

Meeting between the applicant and the APVMA

The 2‑unit fee ($385)

Tier 3

Administration by the APVMA

The 1‑unit fee ($192.50)

Preparation of a written response to the application, including analysis

The 6‑unit fee ($1,155), per module type*.

If the assistance involves more than one module type, more than one 6‑unit fee applies.

Meeting between the applicant and the APVMA

The 2‑unit fee ($385)

\n```\n\n\\* A module type is a type of module set out in one of items 2 to 10 of Schedule 7 to the Regulations.\n\nWhere:\n\n(a) Tier 1 pre-application assistance is for applicants seeking guidance in the early stages of preparing for the making of an application. It is to assist applicants in clarifying the types of regulatory assessments likely to be conducted for a particular submission to inform that applicant in collating relevant information and data likely to be necessary.\n\n(b) Tier 2 pre-application assistance includes all the aspects of Tier 1 with further provision for applicants who are seeking guidance in matters relating to the types of information and data that may be appropriate in a particular submission.\n\n(c) Tier 3 pre-application assistance includes all the aspects of Tier 1 and Tier 2 with further provision for applicants seeking appraisal of the specifics of conducting studies and finalisation of project plans for Global Joint Reviews.\n\nExamples of the application of the above criteria to particular cases:\n\n(a) The 3-unit fee of $577.50 applies for the provision of Tier 1 pre-application assistance consisting of administration and a written response.\n\n(b) The 5-unit fee of $962.50 applies for the provision of Tier 2 pre-application assistance consisting of administration and a written response.\n\n(c) The 7-unit fee of $1,347.50 applies for the provision of Tier 2 pre-application assistance consisting of administration, a written response and a meeting.\n\n(d) The 9-unit fee of $1,732.50 applies for the provision of Tier 3 pre-application assistance consisting of administration, 1 module type (e.g. efficacy and safety) and a meeting.\n\n(d) The 13-unit fee of $2,502.50 applies for the provision of Tier 3 pre-application assistance consisting of administration, 2 module types (e.g. efficacy and safety, and residues) and no meeting.","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"This instrument is a technical, administrative update and does not expand the regulatory reach or create new regulatory obligations. It replaces the 2014 fee‑mapping instrument and clarifies how to calculate unit‑based fees for pre‑application assistance under existing Regulations. The core scope — charging applicants for pre‑application assistance and basing fees on units defined in the Regulations — is unchanged; the instrument only specifies the unit counts associated with particular tiers and assistance elements (see s.1(c), s.4–5)."},"complexity_factors":["Short instrument (single-page with a single operative table — s.4 and s.5)","Small number of clearly defined tiers (3 tiers) and elements (administration, written response, meeting, module types)","One defined monetary unit value ($192.50) referenced from the Regulations (subreg.69B(3) via instrument s.4)","Cross-reference to the Regulations for fee mechanics (subreg.69B(3)–(5)) and to Schedule 7 for 'module types' (s.5)","Simple arithmetic mapping (units × $192.50), with worked examples provided","Some discretionary application risk: APVMA must classify requests into tiers/elements (implementation complexity rather than drafting complexity)","Transitional revocation clause preserving prior instrument for pre‑commencement requests (s.1(c))"],"plain_english_summary":"**What this instrument does (mechanically)\n\n- This is a short administrative instrument made by the CEO of the Australian Pesticides and Veterinary Medicines Authority (APVMA) under subsection 164(1A) of the Agvet Code. It sets out the criteria for working out which pre-application assistance fee applies under the Agricultural and Veterinary Chemicals Code Regulations 1995 (the Regulations) in a particular case (see s.4 and s.5).\n\n- The Regulations express fees in \"units\" and prescribe the monetary value of one unit as $192.50 (GST inclusive) (see s.4). The Regulations also provide that a 2‑unit fee is payable in all cases and that additional units are charged under the Regulations; this instrument tells you how many units different types of pre-application assistance count for (see s.4).\n\n- The instrument divides pre-application assistance into three tiers and lists the elements of assistance that may be provided (administration, written response including research/analysis, meetings). For Tier 3 it also treats “module types” (as defined by Schedule 7 to the Regulations) as separate chargeable elements. The instrument maps each element to a number of units, and the fee in dollars is the unit count multiplied by $192.50 (see the table in s.5).\n\n- It revokes the 2014 pre-application assistance instrument but preserves the old instrument for applications made before this instrument commenced (transitional arrangement, s.1(c)).\n\nWho it affects\n\n- Applicants (companies, researchers or others) who ask the APVMA for pre-application assistance about agricultural or veterinary chemical submissions. Those applicants pay the fee set out by applying the table in this instrument together with the Regulations.\n\n- The APVMA, which administratively classifies the assistance provided (tier, elements, module types) and collects the fee.\n\nWhy it matters (official purpose-claim and operational effect)\n\n- The APVMA’s stated purpose is to provide transparent criteria so applicants know which fee applies for different kinds of pre-application help (see s.4).\n\n- Operationally, the instrument standardises charging: simple administrative queries are low‑unit; written responses and meetings add units; Tier 3 technical inputs multiply costs by module type, so complex technical pre-application assistance attracts higher fees (see s.5).\n\nAnalytical note on incentives, costs, and trade-offs\n\n- Who pays: Applicants pay—each assistance request is priced by unit count (see s.4–5). The APVMA recovers the cost of staff time and expertise through these fees.\n\n- Who decides: The APVMA (via CEO-delegated staff/processes) determines the tier and which elements apply to a particular request. The instrument provides objective categories (tier 1–3 and listed elements) but requires the APVMA to apply those categories to each request (s.5).\n\n- Behavioural effects: Applicants may narrow requests or avoid meetings/module work to limit fees. Conversely, applicants needing multi‑module technical appraisal (Tier 3) should expect multiple 6‑unit charges (one per module type), which raises the marginal cost of comprehensive pre-application technical work (s.5).\n\n- Distribution of costs and benefits: The instrument concentrates clarity and administrative consistency as a benefit for both APVMA and applicants who can budget fees in advance. Costs are borne by applicants seeking advice; smaller or less‑resourced applicants may face proportionally higher barriers where multi‑module technical assistance is required.\n\n- Implementation and compliance risks: The mapping is simple, but it depends on APVMA classification (tier, whether a question requires a written response vs. a simple admin reply, which module types apply). That introduces some discretionary judgment and potential for dispute about unit counts. The instrument cross‑references Schedule 7 module types (s.5), so applicants must check the Regulations to know which module types trigger extra 6‑unit fees.\n\n- Trade-offs and opportunity costs: The schedule makes more complex, technical pre‑application assistance (Tier 3, multi‑module) comparatively expensive. That may reduce the quantity or breadth of early technical engagement with the regulator, shifting some study‑planning costs back onto applicants or leading to a phased approach (pay for selected modules first).\n\nKey mechanical numbers and examples (from the instrument)\n\n- One unit = $192.50 (GST inclusive) (s.4).\n- Examples supplied by the instrument:\n - Tier 1 administration + written response = 3 units = $577.50 (example a).\n - Tier 2 administration + written response = 5 units = $962.50 (example b).\n - Tier 2 administration + written response + meeting = 7 units = $1,347.50 (example c).\n - Tier 3 administration + 1 module type + meeting = 9 units = $1,732.50 (example d).\n - Tier 3 administration + 2 module types (no meeting) = 13 units = $2,502.50 (example e).\n\nRelevant cross‑references you should check when using this instrument\n\n- The Regulations for the underlying fee structure (subregulations 69B(3)–(5)) and the definition/valuation of units.\n- Schedule 7 of the Regulations for the definition of module types used to calculate multiple 6‑unit charges in Tier 3 (s.5).\n\nBottom line\n\n- This instrument does not change what pre‑application assistance is, but it standardises and clarifies how many fee units different kinds of assistance attract. That makes fee outcomes predictable in most cases, but it still requires APVMA classification of the assistance and cross‑checking the Regulations (Schedule 7) to calculate final fees."},"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"The instrument maintains its original narrow purpose: setting pre-application assistance fees. It is a direct replacement of the 2014 instrument with identical scope, merely updating the fee structure and tier descriptions without expanding into new regulatory territory."},"complexity_factors":["Short, single-purpose instrument (approximately 2 pages of substantive content)","Only 3 defined tiers with clear, mutually exclusive criteria","Simple arithmetic fee calculation based on unit multiples ($192.50 per unit)","Single cross-reference to parent Regulations (Schedule 7, items 2–10 for module types)","Straightforward transitional provision preserving old fees for existing applications","No nested exceptions, conditional logic, or discretionary powers","Fee structure presented in readable table format with worked examples"],"plain_english_summary":"The instrument sets a tiered fee schedule for pre-application assistance from the APVMA, charging applicants for administrative help, written advice and meetings before lodging pesticide or veterinary medicine registrations. It uses fee “units” (A$192.50 each) and scales from basic guidance to detailed technical appraisals, so simple queries are relatively cheap while complex, multi‑module or international review support can be much more costly. It tells companies and advisers what to expect to pay upfront."}},"importantCases":[],"_links":{"self":"/api/acts/agricultural-and-veterinary-chemicals-code-pre-application-assistance-fee-instrument-2015","history":"/api/acts/agricultural-and-veterinary-chemicals-code-pre-application-assistance-fee-instrument-2015/history","analysis":"/api/acts/agricultural-and-veterinary-chemicals-code-pre-application-assistance-fee-instrument-2015/analysis","conflicts":"/api/acts/agricultural-and-veterinary-chemicals-code-pre-application-assistance-fee-instrument-2015/conflicts","importantCases":"/api/acts/agricultural-and-veterinary-chemicals-code-pre-application-assistance-fee-instrument-2015/important-cases","documents":"/api/acts/agricultural-and-veterinary-chemicals-code-pre-application-assistance-fee-instrument-2015/documents"}}