Seeking input into how the APVMA provides pre-application assistance

This consultation closed on 3 July 2015.
Consultation period: 
11 June 2015 to 3 July 2015

Submissions are invited from interested stakeholders on how we provide assistance to industry, and in particular how we provide assistance to assist people in making and preparing applications.

Background

Under new arrangements introduced on 1 July 2014, a potential applicant may apply to the APVMA for regulatory assistance prior to the submission of an application to register or amend a pesticide or veterinary medicine product. A new scheme was introduced—Pre-application Assistance Arrangements (PAA), which includes a system for charging for PAA advice, as required by the Agricultural and Veterinary Chemicals Code Regulations (Pre-application Assistance Fee) Instrument 2014 and 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 PAA scheme.

The review highlighted that the implementation of PAA had not meet 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 implement all the recommendations arising out of the review and to re-designing the PAA process from beginning to end to meet our clients’ needs.

Following initial discussions with some users of PAA we have developed a draft approach for handling all types of pre-application advice and guidance—including PAA under the legislative scheme.

Integration of all forms of pre-application assistance and guidance

Industry can access assistance and guidance in a variety of ways including the website, by calling or emailing our general enquires line, by applying and paying for Pre-application assistance as well as through technical assessment.  The external review highlighted the need to provide clearer information for industry on the types of assistance and guidance available—so they can select the appropriate level of assistance to suittheir particular circumstance.

A re-designed PAA service could see all forms of pre-application assistance and guidance integrated into a common fit for purpose process to help meet all pre-application needs.

A common process could filter all requests for assistance using a system of three-tiers which would reflect the effort/complexity required, such as:

  • general advice
  • technical advice, and
  • technical assessments.

A description of the three possible tiers of advice is presented below for discussion.

 types of information or data required to address the statutory criteria for a specific regulatory proposal, the relevance of the efficacy or trade criteria for a specific regulatory proposal, potential relevance of overseas data and/or assessment reports for a specific regulatory proposal, how to develop an agreement on the project plan for a timeshift application, which may include agreements for global joint review applications, suitability of trial protocol, potential suitability of label instructions, and DMPRR (requiring technical consideration of project attributes). The diagram shows that stakeholders can apply for specific technical advice through the online portal and that timeframes and fees will apply. The third tier is the Assessment of data. The example provided is the assessment of a data package. The diagram shows that stakeholders can apply for the assessment of data through the online portal for a technical assessment (Item 25) and that timeframes and fees will apply.

By using a tiered approach which integrates all forms of pre-application assistance and guidance the APVMA could:

  • broaden the scope of PAA to all types of technical assistance including protocol assessments
  • offer modular timeframes based on the complexity of the technical advice
  • offer a modular fee structure based on complexity of the assistance provided.
Tier Principle Types of assistance Examples Timeframe Fee

General assistance (enquiry)

 

General guidance
  • the online portal
  • status of your application
  • finding information on the website
  • making an application - general administrative requirements
  • does my product require registration (general)
  • how do I apply for a permit?
  • how do I register my product?
  • how do I apply for consent to import?
Client service charter Nil

Specific technical assistance for PAA

Technical/ scientific opinion or recommendation related to a specific proposal 


No assessment of data (may look at data but not technically assess)

  • types of information (data) required to address the statutory criteria
  • the relevance of the efficacy or trade criteria 
  • assistance on generating information to support an application
  • assistance on likely assessment, fees and timeframes

1 month

 

Simple PAA (read and answer quickly)

Flat fee on application

  • potential relevance of overseas data and/or assessment reports
  • how to develop an agreement on the project plan for a timeshift application, which may include agreements for global joint review applications
  • Suitability of overseas data
  • Assistance on the types of supporting information that may be needed to support an application
  • Development of a project plan for a ‘timeshift’ application

2 month

 

More complex PAA question

Research required

Need input
Modular fee based on complexity
  • suitability of trial protocol
  • potential suitability of label instructions
  • assistance to determine whether a trial protocol would be likely to give data suitable for regulatory purposes
  • are the proposed labelling instructions complete and/or suitable to meet the labelling criteria if data supports them

2–3 months

 

Complex

Meeting requested
Modular fee based on complexity

Technical assessment 

(Item 25)

 

 

Data assessment


Assessment where data is provided related to a specific proposal

Data assessment

  • Assessment of a data package, including assessment of:
    • data an applicant is considering submitting to the APVMA as part of a proposed application for registration
    • an overseas data package to determine whether the data is sufficient to address the statutory criteria for a regulatory proposal to be made in Australia.
Confirmation that the data addresses the environmental exposure aspects of the safety criteria

As provided for under

 

Agricultural and Veterinary Chemicals Code Regulations 1995

Charging arrangements

The external review found that the current PAA arrangements impose unnecessary costs on applicants and the APVMA, slows the processing of applications and recommended the APVMA seek to have the current charging arrangements removed or revised to make them less burdensome and more efficient, including eliminating or simplifying the process. The APVMA was also asked to consider a charging system based on similar principles to the modular arrangements currently applied for other applications.

The principle of charging for PAA and the level of the fees to be applied is set out in the Agricultural and Veterinary Chemicals Code Regulations 1995 and therefore is beyond our direct control of the APVMA. However, changes could be made to the implementation of the charging arrangements which is contributing to the cost and complexity of managing PAA.

The current process and methodology for calculating charges is complex and involves multiple transactions between different parts of the APVMA and the applicant for relatively small sums of money. Given the very small sums of money collected, it could be more efficient to offer flat fees and/or a tiered level of charges for different kinds of application. Your comments are sought on possible revised charging arrangements.

Any changes to the charging arrangements are likely to require amendments to the Agricultural and Veterinary Chemicals Code Regulations (Pre-application Assistance Fee) Instrument 2014.

Input sought

Your feedback is sought on the proposed:

  • integrated approach concept
  • three tiers and the different types of assistance and principles underpinning each tier
  • expected timeframes for the provision of assistance
  • reasonable module fee arrangements

Consultation information

The APVMA is seeking feedback on its draft proposal for new pre-application assistance arrangements.

Please email your written submission marked 'PAA consultation submission' in the subject line to enquiries@apvma.gov.au

Or post to:

Director, Case Management and Administration Unit
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston ACT 2604

Closing date for submissions: 3 July 2015

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

To protect your privacy, please do not include contact information in your feedback. If you would like a response, please contact us.