Seeking comment on the draft Pre-application Assistance Fee legislative instrument

Submissions are invited from interested stakeholders on the draft Agricultural and Veterinary Chemicals Code (Pre-application Assistance Fee) Instrument 2015.

Following consultation we expect the instrument will be tabled in October 2015 and made available from the APVMA website as part of the overall improvement to pre-application assistance arrangements.

Background

Under new arrangements introduced on 1 July 2014, a potential applicant can apply for regulatory assistance before submitting an application to register or vary a product or to approve a permit or active constituent.

These pre-application assistance arrangements include a system for the APVMA to charge a fee for the assistance provided. The current fee arrangements are set out in detail in the Agricultural and Veterinary Chemicals Code Regulations (Pre-application Assistance Fee) Instrument 2014 and administrative requirements are in the Agricultural and Veterinary Chemicals Code Regulations 1995.

Following feedback from industry and stakeholders we undertook an independent review on the implementation and operation of the pre-application assistance arrangements, including the system for charging fees.

The review found that implementation had not met the standards required by our clients, and that we did not have adequate systems and processes in place to support it.

We have committed to address all the recommendations of the review and to re-design the process to better meet the needs of people seeking assistance with applications.

In consultation with industry we have developed a new integrated approach for handling all types of application advice and guidance—including the pre-application assistance arrangements described in the legislation.

As part of the new approach, a new legislative instrument has been drafted to replace the existing instrument and is now available for public consultation and comment.

Draft Instrument

The draft Instrument (PDF 31 KB) | (DOC 103 KB) and explanatory statement (PDF 88 KB) | (DOC 206 KB) sets out the criteria for working out unit-based fees and revokes the Agricultural and Veterinary Chemicals Code Regulations (Pre-application Assistance Fee) Instrument 2014.

Input sought

We are seeking feedback from all interested parties on the draft legislative instrument to ensure it:

• meets the needs of people seeking assistance under the pre-application assistance arrangements
• provides clear guidance on how fees will be charged and managed.

Consultation information

Please email your submission with ‘Submission to PAA Legislative Instrument Consultation’ in the subject line to enquiries@apvma.gov.au

Or post or fax to:

Enquiries

Case Management and Administration Unit
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604

Fax: +61 2 6210 4840

Closing date for submissions: 28 September 2015

For any further information please contact enquiries@apvma.gov.au or telephone +61 2 6210 4701.

Proposed integration of all assistance and guidance

Submissions are invited from interested stakeholders on the Agricultural and Veterinary Chemicals Code (pre-application Assistance Fee) Instrument 2015.

The review of pre-application assistance arrangements highlighted the need to provide industry with clearer information on all types of assistance and guidance available—and to give people the opportunity to select the level of assistance which suits them.

Re-designed pre-applications assistance arrangements

New arrangements planned to come into operation from October 2015 will mean all forms of assistance and guidance are integrated into a common, fit for purpose process.

The new process will filter all requests for assistance and guidance to reflect the effort and/or complexity required and the level of support needed, such as:

• general assistance
• technical advice
• technical assessments.

General assistance

General assistance is the first level of support we provide and includes clarification on general administrative requirements and help to find information on our website.

Technical advice (pre-application assistance)

If you need technical advice to make an application this would be done under the fee-for service pre-application assistance arrangements.

Pre-application assistance has been divided into three tiers so the fees we charge directly relate to the complexity and effort required.

Tier 1

Tier 1 pre-application assistance is designed to support the early stages of preparing an application such as guidance on the types of assessments necessary for the proposed application.

Tier 1 assistance has a one month timeframe and can include a meeting if needed. We will provide guidance and assistance on:

• planning your application
• the types of regulatory assessments likely to be needed for an application
• the relevancy of efficacy criteria
• likely assessment modules, fees and timeframes
• clarification of guidance documents on the website.

Tier 2

Tier 2 can be used for technical advice to support a particular application. Tier 2 has a two month timeframe and can include a meeting if needed. We will provide advice and assistance on:

• types of supporting data or information appropriate to the application
• relevance or suitability of overseas data and/or assessment reports
• the types of trials needed to generate required data
• a scientific matter relevant to an application
• the development of an agreed project plan for a timeshift application
• specific aspects of the design of a study or trial.

Tier 3

Tier 3 advice can include appraisal of specific study design and finalisation of project plans for Global Joint Reviews. Tier 3 has a three month timeframe and can include a meeting if needed. It can include:

• appraisal of trial protocols before commencement of studies
• assistance on a proposed new methodology or variations to existing data guidelines for generating data
• finalisation of project plans for Global Joint Reviews.

Technical Assessment (Item 25)

Technical assessment is reserved for determining that a data package addresses the safety, efficacy or trade criteria. An outcome of a technical assessment can be used by an applicant as part of a future product application.

The fees and timeframes for a technical assessment are modular—which the modules selected are based on the type and level of assessment. Under an Item 25 application, the APVMA will conduct a full technical assessment of a data submission. This may include assessments of data that is intended to be relied on to support a future application, including overseas data to determine its relevance to the safety, efficacy or trade criteria.

New charging arrangements for technical advice (pre-application assistance)

The review found that the current charging arrangements for pre-application assistance imposed unnecessary costs on both applicants and the APVMA and slowed processing.

As the principle of charging for pre-application assistance and the fees are set out in the legislation, the APVMA is seeking to improve the implementation at the administrative level within the current legislative arrangements.

The current process and methodology for calculating charges is complex and inefficient, involving multiple transactions between the APVMA and the applicant resulting in delays in the provision of advice. To reduce regulatory burden and improve delivery, a system of flat fees and a tiered level of charges is proposed.

Submissions are invited on proposed amendments to the Agricultural and Veterinary Chemicals Code Regulations (Pre-application Assistance Fee) Instrument 2015.

Elements of the proposed charging arrangements

The new charging arrangements would include mandatory and optional components including:

• a mandatory flat administration fee
• a mandatory unit feed structure relevant to the tier
• an optional fee to meet with the APVMA on any tier of assistance

Charges for the various elements of assistance is provided below.

* the unit cost and module types are set out in Schedule 7 of the Agricultural and Veterinary Chemicals Code Regulations 1995