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News and Views for July 2009

Annual fees for 2009-2010 year coming up

It’s almost time for the collection of ACVM annual fees. Below is an approximate timeline for the process:

• 20-24 July: Product lists* will be sent out to major registrants for any product cancellations. (If you don’t receive a product list but you want one, email Jane Chuang.)

• Mid-August: Product lists are due back for updates

• Mid-September: Invoices for annual fees will be sent out to registrants

• 1 October: Due date for annual fees. Any fees not received by this day will incur a 10% penalty and registrants may have their products prohibited from importation and manufacture.

For any question on annual fees, contact Jane Chuang.

*A new section on the vet med and ag chem product lists is for you to indicate whether or not we can access your product residue data for setting export WHPs, confirming compliance with domestic MRLs and supporting official assurances. (See Export Spray Programmes in last month’s issue.)

Outstanding payments could affect your Approved Creditor status

NZFSA policy for payment: all invoices are due the 20th of the month following date of issue.

A small number of outstanding invoices need to be cleared as soon as possible. If you're one of our Approved Creditors, any outstanding invoices on your account could affect your Approved Creditor status. Contact Jane Chuang if you need our bank account number for payments. 

Changes to the adverse event reporting (AER) system for vet meds

AERs are a vital post registration monitoring tool used by NZFSA. They highlight issues that were not identified during the registration process and enable ongoing management of the risks under the ACVM Act. Inadequate label warnings, batch-related issues, rare side effects not noted during registration trials and lack of efficacy can be detected and addressed through an efficient AER system.

Updated form

Recently we updated our AER form and procedures (see March News and Views). The changes made were to reflect the process that we already use. Also, in the interests of harmonisation with the Australian Pesticides and Veterinary Medicines Authority (APVMA), our changes took into account the APVMA Adverse Event Reporting Program for Veterinary Medicines.

The form has been changed so that the information required for efficient processing of AERs is clearly identified and time is not wasted with ongoing requests for more information. Registrants have also been prompted to make an assessment and trend analysis for AERs they receive. Most do this already -- the form has just clarified the requirement for processing AERs.

Timeframes have not changed

The timeframes imposed are the same ones NZFSA has been using for processing AERs. Registrants must report serious AERs within 7 working days and non-serious AERs must be reported within 20 working days. A complete assessment and conclusion is not required within these periods, but the event must be notified within these timeframes and an agreement made over an appropriate follow up time.

No more annual reports

It is intended to remove the condition of registration requiring adverse events to be reported annually as NZFSA has not identified the value associated with the requirement and does not intend to allocate the resources to process large numbers of AERs at once. (This condition change will happen at registration renewal or after mid-August for new/variation registrations.)

Queue jumping revisited

We recently reminded you that all registration, variation, provisional and research approval applications go into the processing queue as they arrive (see May News and Views). There was some feedback so we are providing further explanation.

We have this rule:

• to ensure we treat all applicants equally

• to ensure we meet the statutory timeframes

• to provide predictability to you as applicants so you know when your registration is likely to be completed.

However, we will consider swapping applications in the queue if:

• the applications to be swapped are from the same applicant

• the assessment phase of processing, which triggers the statutory timeframe clock, has not started.

Requests to swap your applications must be made to Trish Whitaker or Maree Zinzley.

Registration period to stay at 3 years

Some registrants have suggested extending the product registration period from 3 to 5 years. At present several changes stemming from the ACVM Act amendment (eg, conditions of registration, public register information) must be made and the 3 year period is more appropriate to ensure these changes are implemented in a timely manner. We will reconsider extending the registration period after these changes have been completed.

New PDS application forms must be used

Please remember that the new PDS forms, which went through several months of consultation, must be used from 1 September 2009. NZFSA has legal obligations to provide certain information on the public register and the old forms do not give us the information needed.

Matching substances and trade name products

Because ERMA NZ deals with substances and we deal with trade name products, it has been difficult to be certain that an ERMA ‘status of substance’ (SOS) application is for the trade name product in an ACVM registration application. Our new PDS forms have an expanded HSNO section to provide us with information needed to be sure there is a match. We have also asked ERMA to add a spot for trade name of product to their application forms.

Data protection update

Although the interdepartmental discussion on this subject took longer than originally anticipated, the Covec Study Report and the associated public discussion document have now been released.

Special circumstances approvals

NZFSA is working with ERMA NZ to facilitate special circumstances approvals under section 8C of the ACVM Act. This is on the basis that before NZFSA can issue such an approval, the appropriate HSNO approval is necessary when the product is subject to the HSNO Act, as is the case for products requiring registration. The likely outcome is the development of a group standard for those veterinary medicines that need special circumstances approval.

August workshops planned

Group standards workshop

On the subject of group standards, industry has indicated there are areas of confusion and concern on how they work and their relationship between the HSNO and ACVM Acts. Therefore, ERMA NZ and NZFSA intend to hold a workshop on them in Wellington in late August 2009. The workshop will cover roles and responsibilities of ERMA NZ and NZFSA, how group standards work and industry perspectives (pros and cons). The main emphasis will be on how group standards could work for veterinary medicine products.

We will work with AGCARM and ARPPA to develop the programme and to determine who should be present at the initial workshop, but we will also consult on any actions arising. Industry will be invited to make presentations from their perspectives.

Data assessment service working group

We plan to review our data assessment service, which was introduced a number of years ago. It is timely to revisit this service, particularly when considering how the environment has changed. To get industry’s perspective on how it has been operating and its future direction, we will hold a workshop in August. We have contacted AGCARM and ARPPA to get nominations for the working group. The outcomes from the working group will be considered by AVMAC and will also be put out for comment to all interested and affected parties.

For more information, contact Warren Hughes.

Aminoglycoside review—next step

The reassessment of registered veterinary products containing aminoglycoside antibiotics began on 1 July 2009 (see February News and Views). A reassessment is treated as a new application and therefore is charged as per the current hourly rate. A pre-screen fee will be charged only if this step is actually performed.

When the reassessment is complete, we intend to update the conditions of registration for these products to reflect the new restricted veterinary medicine classification system. This will also require a change to labels, ie the current PAR statement will be replaced with a signal heading for restricted veterinary medicines. The timeframe for these label changes will be agreed with each affected registrant, depending on the outcome of the reassessment and stocks of product held.

IR-4 Arrangement Agreement

NZFSA and IR-4* in the USA have signed an Arrangement Agreement. This Agreement recognises both parties understand that the lack of minor uses/crops for pesticides is a barrier to productivity in the agricultural and horticultural sectors and organisations need to explore ways to promote/facilitate minor uses/crops. The Agreement formalises the relationship between the two parties and, hopefully, will lead to exchange of information to facilitate minor uses/crops in each country.

*What is IR-4?

The IR-4 Project is a cooperative program of the USDA and the State Agricultural Experiment Stations (SAES), with the principle goal of developing data to support and to expedite regulatory clearances of newer, reduced risk pest control products for specialty crop growers in the United States. This cooperative program is a model partnership between the USDA’s Cooperative State Research, Education, and Extension Service (CSREES), its Agricultural Research Service (ARS), and SAES of the nation’s land grant university system.

The IR-4 Project conducts the research necessary to support a wide variety of specialty crop pesticide applications needed to maintain a stable and safe food supply for the US and support the ornamental crop market. In particular, the IR-4 Project provides the field trial and laboratory residue data necessary for US EPA clearance of minor crop tolerances and approval of new uses for pesticide labels.

Organisation for Economic Co-operation and Development (OECD) meeting highlights

June-July, Paris

Warren Hughes and John Reeve from NZFSA attended the recent series of OECD and Government meetings on pesticides. At the Working Group on Pesticides meeting John Reeve commenced his chairing of the Group, taking over from the United Kingdom chair. (The chair is rotated every 3 years.)

The OECD meetings cover a range of activities, but the main one is development of guidance documents for the registration of pesticides. Key points from this series of meetings:

• A number of guidance documents were approved.

• The New Zealand paper on meeting efficiencies was adopted. (The purpose is to reduce costs to OECD members by ensuring meetings are held only when necessary and meeting locations/venues are rotated.)

• Work is continuing on ways to facilitate minor uses/crops claims for pesticide products. One of the key areas being worked on is data sharing among regulators and industry.

• A meeting between EFSA/EC/OECD was successful in that progress was made to ensure work sharing continues. (In work sharing, regulators from various countries work together on data packages for a new compound. This speeds up registration and reduces costs to registrants.)

• Work is progressing on the development of the maximum residue limits (MRL) calculator. Its purpose is to assist regulators in determining the appropriate MRL for a crop/active ingredient combination by inputting results from residue trials. The advantages of this are consistent MRLs in countries where the same or similar data sets are used and, as a result, the MRL should better reflect enforcement of good agricultural practice.

• The network of spray drift experts from various OECD countries will now have access to a web portal to allow exchange of information.

I’m not happy about...

If you are not happy about some aspect of your dealings with us, and your key account manager has not taken care of the situation to your satisfaction, contact Operations Manager Maree Zinzley. This contact should be in writing so our records are complete.

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