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News and Views for September 2008

Welcome to the ACVM Group’s online newsletter. News and Views, which replaces AgVetLink, will be updated whenever we have news/issues etc that you should know about. We intend to keep it ‘short and sweet’. Issues that require more in-depth analysis will be summarised here and linked to relevant web pages.

Annual fees due before 1 October

Please remember that all invoices are due for payment before 1 October 2008. If payment is not received before this date the following action will be taken:

• you will receive a 10% penalty invoice under section 18 of the Ministry of Agriculture and Fisheries (Restructuring) Act 1995

• your product(s) will be prohibited from importation and/or manufacture under section 82 of the Agricultural Compounds and Veterinary Medicines Act 1997

• the prohibition notice will not be removed until payment on all outstanding debts and any penalty fees have been received.

Invoices and product lists for ACVM annual fees were posted in August. If you have not received your invoice, or if you have any questions, please contact:

Jane Chuang, Co-ordinator (Business Services), Approvals and ACVM Group
PO Box 2835, Wellington
Tel: 04 894 2563
Fax: 04 894 2566
Email: jane.chuang@nzfsa.govt.nz

New fees from 1 July 2008

Reminder: New fees and charges under the ACVM Act came into force on 1 July 2008.
Read the fees schedule for all the details

ACVM Act document receives 11 submissions

The consultation period for the first public discussion document on regulatory change was extended to the end of July, rather than closing on 11 July 2008.

NZFSA received 11 submissions on the document. (A summary of submissions will be posted onto the consultation section of the website shortly.) In general, none had significant concerns with the overall approach being proposed. However, some of the submissions did raise concerns over the proposals for:

• regulations to cover third party advertising

• compounding.

In light of these concerns, NZFSA is considering whether it should proceed with these proposals as originally developed and will keep you informed via News and Views.

ACVM Act implementation work currently under way

We are busy at the moment:

• working with NZFSA’s Policy Group and legal team on the appropriate regulatory mechanisms for implementation

• updating registration application forms (product data sheet or PDS) and information requirements, including provisional registrations

• developing policy, procedures and processes for recall or suspension of agricultural compounds and approval under special circumstances.

Cross-referencing applications need improvement

We receive a wide range of applications that make reference to the information provided in support of other registrations. This occurs with generic products (B2 applications), but it is also common for A2 applications (new species, formulation types or claims) to reference existing approvals.

The poor quality of many of these applications is causing considerable difficulty for data assessors as well as ACVM staff appraising information waivers and applications for registration. Most of the problems occur where information is referenced from several products and the big picture is lost.

Focus on actives—not formulations

The primary cross-reference must be made to products with data that support the active ingredients in the new application. This is the fundamental basis for the claims.

In establishing an argument to support stability, efficacy, safety and/or residues a reference may be made to similar formulations that contain different actives. This is where the problem develops. It is not unusual for applications that focus on the formulation rather than the active to propose claims that were never supported for the actives in the formulation to be registered.

As a general rule reference should be made to the original product, but in practice it may be more appropriate to include more recent products that were approved based on data that is more up to date or applicable.

Make sure your application is correct

If you do not cite the appropriate cross-references that support a registration application it is likely your application will be declined. Although the ACVM Group may be able to use knowledge of other products that are not referenced in making a decision, it is the applicant’s responsibility to make sure that the application is complete and supported by adequate argument and information.

When cross-referencing, always: • Cross-reference a product or products containing the same actives as the proposed formulation. • Construct a clear and logically structured application drawing together arguments based on equivalence and data specific to the proposed product. • Remember that data on innovative actives cannot be referenced for five years.

APVMA visit brings harmonisation closer

APVMA’s CEO, Eva Bennet-Jenkins, and two of her managers, John Paul and Neville Matthews, visited the ACVM Group in August to discuss a range of topics. A few of the highlights from the visit were:

• Alignment project: Progress was made on the side-by-side comparisons of information requirements for each country for agricultural chemicals and veterinary medicines. There is a proposal to pilot a parallel assessment of a registration application submitted in each country at the same time. This would assist in determining how well each country’s information requirements are aligned and give a better understanding of how each country undertakes its process, including risk management.

• Registration by reference: The ACVM Group and APVMA intend to trial ‘registration by reference’. When a veterinary medicine registration application is submitted in New Zealand for a product that is already registered in Australia, the ACVM Group would utilitise the Australian data assessment reports and APVMA’s regulatory assessment report (known as the TERA) as a basis for decision and risk management. At present, this is likely to be limited to companion animal (ie non food-producing) products. Both regulators are working on the final steps for this trial to occur.

• International co-operation: APVMA and the ACVM Group have proposed to work more closely together on some of the international fora such as VICH and OECD.

• Adverse Event Reporting: The two organisations will explore options on how to work more closely together in this area.

• Memorandum of Understanding: It was agreed that, in light of some of the activities, the current MoU between APVMA and the ACVM Group needs to be refreshed.

• Mutual interest: Updates were given in a number of areas of mutual interest such as data protection, Access Status Policy, bee products, and MRLs. The meeting was valuable for both organisations and it was agreed a more regular schedule of meetings would be beneficial.

Reports from conferences and seminars

The following short summaries of recent conferences and seminars provide you with ACVM highlights.

APVMA Registration Seminar: ‘Back to Basics’

12-13 June 2008, Canberra

This was APVMA’s first registration seminar in five years. In light of recent work in terms of building trans-Tasman relationships and identifying areas where harmonisation may be achieved, APVMA kindly invited ACVM staff to attend. Nasser Ahmed (Advisor: ACVM Standards-Animals) and Bruce Nalder (Advisor: Plants) attended on behalf of the ACVM Group.

• Sessions divided into streams: The seminar started with an introduction to the APVMA, governing legislation, electronic payment of charges and an overview of the registration process. Later sessions were split into different streams for veterinary chemicals, agricultural chemicals, data, and registration and communication.

• Communication encouraged: Presentations covered a wide variety of topics related to the APVMA registration process, with an emphasis on common application issues, deficiencies/mistakes and encouraging increased communication between applicants and the APVMA throughout the registration process, but particularly during planning/development and prior to submission of ‘major’ applications.

• Annual visit suggested: APVMA suggested that it would be useful for companies to visit them annually and provide updates on submissions proposed for the coming year. This way, APVMA would have an indication of likely workloads and resources required.

• Slides available: Although conflicting times meant that not all sessions could be attended, attendees were provided with a bound copy of presentation slides.
Slides of sessions are also available via the APVMA website

• Thanks: Not only did the seminar provide a forum for discussion on the registration process, it also provided a chance to meet with APVMA staff, Australian-based registrants, prospective registrants and consultants. Our thanks to APVMA for the invitation to attend.

APVMA Industry Technical Liaison Committee meeting

While in Canberra, Bruce and Nasser had the opportunity to attend an APVMA Industry Technical Liaison Committee (ITC) meeting. The ITC, which meets approximately 3 times a year, is made up of representatives from the Industry Liaison Committee (ILC) and specialist technical groups. It supports the ILC (the main industry forum) by addressing technical issues affecting regulatory policy, programs and performance.

ACVM challenges are not unique: From an ACVM perspective the meeting provided some insight into APVMA’s relationship with industry and their consultation process. The meeting was well chaired and industry comments generally well thought through and presented. From some of the discussions it was clear that challenges faced by the ACVM Group in terms of maintaining appropriate staff capability and managing processes, including regulatory timeframes, are not unique to New Zealand.

Society of Environmental Toxicology and Chemistry (SETAC) World Conference

3-7 August 2008, Sydney

Andrew Pearson attended the 5th Society of Environmental Toxicology and Chemistry (SETAC) World Conference in Sydney. Highlights were:

• Emerging issues: A number of emerging issues such as polyfluorinated alkyl substances and the large amount of work being undertaken to characterise estrogenic compounds in dairy effluent were discussed.

• Seminars: There were interesting seminars on work undertaken in determining polychlorinated dibenzodioxins in Sydney Harbour and the advances in charting bioavailability and crop uptake of heavy metals (particularly cadmium) through soil contamination. It was a good opportunity to network with people involved in these areas of work.

• Risk assessment: There was a very insightful half-day course on interpreting human and statistical error in risk assessment.

New Zealand Plant Protection Conference

11-14 August 2008, Paihia

Warren Hughes, Beth Dye and Rebecca Fisher attended this annual conference, which is an opportunity for the ACVM Group to keep abreast of research developments in the agricultural chemical industry and to network with other industry sectors, particularly researchers and chemical companies. This year Warren Hughes chaired the session on Agrichemicals. Highlights were:

• Movement toward sustainable management: Historically, the backbone of the conference has been presentation of papers on chemical control. This year’s conference highlighted the movement away from research on traditional chemicals, and more into areas on sustainable management including biological control.

• Possible merger announced: While the conference was proceeding, Crop and Food and HortResearch released a press statement that both organisations were looking at the possibility of a merger. It was interesting to hear the immediate feedback from those attending the conference on the benefits or otherwise of such a merger.

We hope you enjoyed this first issue. Remember to check back for the latest News and Views!
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This page was last updated on 17 September 2008.