This consultation closed on 3 July 2015
Consultation period
11 June 2015 to 3 July 2015Submissions 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.
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 |
|
|
Client service charter | Nil |
|
Specific technical assistance for PAA |
Technical/ scientific opinion or recommendation related to a specific proposal
|
|
|
1 month
Simple PAA (read and answer quickly) |
Flat fee on application |
|
|
2 month
More complex PAA question Research required Need input |
Modular fee based on complexity | ||
|
|
2–3 months
Complex Meeting requested |
Modular fee based on complexity | ||
|
Technical assessment (Item 25)
|
Data assessment
|
Data assessment
|
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.