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News and Views for June 2009

New application forms must be used from 1 September

The revised application/product data sheet (PDS) forms that are available on our website must be used for new/variation applications from 1 September 2009. These new forms provide us with information needed to meet our legal requirements for the public register under the amended ACVM Act. Applications submitted on the old forms after 1 September will be sent back.

No application in the pipeline?

Registrants who do not submit an application for a registration or a renewal during the next few months will be asked to supply the information on responsible manufacturer* that we need for the public register. We want to have this information in hand by 1 December 2009. 

If you are not submitting an application during this timeframe, please provide the relevant page of the new PDS with the responsible manufacturer information to update our records. This can be supplied by fax (04 894 2566), post (PO Box 2835, Wellington 6140) or email (acvm@nzfsa.govt.nz). Don’t forget to provide the name and registration number of the product! 

Desk top audit of nominated responsible manufacturers

For products that require manufacturers to be recognised (ie the majority of veterinary medicines and vertebrate toxic agents [VTAs] manufactured in New Zealand), NZFSA will undertake a desk top audit this year (July 2009 - June 2010) to ensure that the nominated responsible manufacturer has the documentation describing the necessary quality assurance checks and ‘release for sale’, records are maintained and there is a nominated staff member responsible.  This will form the basis of the initial recognition and, in future, a site audit (at a frequency of 2-3 years) will be scheduled for New Zealand-based companies.  

GMP compliance issued by a regulatory authority that NZFSA deems acceptable (EU, APVMA, FDA, Health Canada) will be required for overseas companies.  

Responsible manufacturers unknown to NZFSA will be contacted after 1 December 2009 to supply the required documentation for the desk top audit.

For more information, contact us.

*The responsible manufacturer is that entity who ensures the product is in compliance with its NZFSA registration and releases it for sale. 

 

Outstanding debt could affect Approved Creditor status

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

Outstanding invoices need to be cleared by the end of June 2009, which is the end of our financial year. If you're one of our Approved Creditors, any outstanding invoices on your account could affect your Approved Creditor status. To get our bank account number for payments, contact Jane Chuang (jane.chuang@nzfsa.govt.nz)

‘Restricted veterinary medicines’ system to go ahead

Recent workshops held throughout the country explained the proposed new veterinary medicine classification system (see May News and Views). From NZFSA’s perspective no significant issues were raised at the workshops or in submissions received to cause a rethink of the proposed changes from prescription animal remedies (PARs) to restricted veterinary medicines. Therefore, the Approvals and ACVM Group will update documents and begin implementing the changes soon.

Receivers not allowed to sell PARs

Two farms that went into receivership recently had stocks of prescription animal remedies (PARs) that the receivers put up for sale. This is illegal because the receivers are not approved PAR traders. A vet practice has set the receivers straight and the products have been withdrawn from sale.

However, given the current economic climate, we are concerned that the above scenario may not be unique, and we would appreciate notification if you are aware of any similar situations. Please contact Linley Thorburn (linley.thorburn@nzfsa.govt.nz).

Labels checked for ACVM requirements ONLY

Reminder to vet med registrants

We check labels for ACVM requirements. Any OK you receive from us about your label relates ONLY to ACVM essentials. Other label requirements are monitored by other government authorities, for example:

• hazardous substance/new organism (HSNO) statements are regulated by the Environmental Risk Management Authority (ERMA)

• misuse of drugs statements are regulated by the Ministry of Health. 

Help! I need more time…

In addition to our occasional requests for more time during processing of registration applications, we are often asked for time extensions. Requests relate to technical or non-technical aspects of an application, and our general policy is as follows:

• when the request for more time relates to technical material:

- if the information is available, eg through an overseas source, normally a 30 day time extension will be given

- If the information is not available, ie you are still trying to generate it, you will be asked to withdraw the application and re-submit it when you have the information

• when the technical appraisal is completed, a request for more time relating to label changes, MRL requirements, ERMA requirements etc is likely to be given.

Conditions of registration to be reworded

The conditions of registration of trade name products are being reviewed. The objective is to reword the existing conditions for greater operational clarity and to take into account recent changes, eg restricted veterinary medicines.  However, the rephrased conditions will essentially have the same intent as the current conditions. 

The changes will appear on the public register and on certificates of registration for trade name products. Although changes will start in the near future, NZFSA plans to phase in the changes over time. We will provide more details nearer the time of commencement.

Codes of practice and operating plans

NZFSA is reviewing existing codes of practice as a result of an amendment made to the ACVM Act in October 2007. The amendment to section 28 of the Act provides NZFSA with the power to approve operating plans rather than codes of practice. The amendment allowed for a transition period in which approved codes of practice would be deemed operating plans. This transition period ends in October 2010.

Codes may fit operating plan model or industry guideline model

Operating plans will be written statements of how a particular party or group intends to meet their statutory obligations. Unlike codes of practice, they will not be used as guidance to a sector. Those approved codes of practice that are specific to a single group and detailed sufficiently to be auditable expressions of that group’s operations are considered to fit the operating plan model. Others fit the model of industry guidelines.

Code of Practice for Routine Induction of Dairy Cattle to become industry guideline

As part of the review, NZFSA has begun consulting with the sponsors for each code of practice. Representatives from the New Zealand Veterinary Association (NZVA) and its Society for Dairy Cattle Veterinarians, the Veterinary Council of New Zealand (VCNZ), DairyNZ, the Dairy Companies Association of New Zealand (DCANZ), Federated Farmers and MAF Biosecurity New Zealand (BNZ) Animal Welfare attended a working group last month to discuss the future of the Code of Practice for Routine Induction of Dairy Cattle, which is currently approved under the ACVM Act.

It was agreed at the working group that the best plan for dealing with this code was for it to become an industry guideline rather than an approved operating plan under the ACVM Act. The sponsors of the code, NZVA and DairyNZ, will rewrite the code to ensure it is up to date. They will also work in conjunction with VCNZ and MAF BNZ Animal Welfare Group to ensure the code is written in such a way that it will be auditable and a useful tool to be referenced in the Dairy Cattle Code of Welfare.

When the guideline is complete, the sponsors can seek NZFSA’s opinion on the requirements that relate to the ACVM Act.

Next consultation

The next code that will be considered is the National Velvetting Standards Body Code of Practice for the Use of Prescription Animal Remedies.

Reassessment of veterinary medicines that contain aminoglycoside starts 1 July

NZFSA will begin its reassessment of registered veterinary products containing aminoglycoside antibiotics on 1 July 2009. The reassessment is in response to the recommendations from the report of the Antimicrobial Resistance Expert Panel (30 August 2005) and the advice of the Antimicrobial Resistance Steering Group. For the full background to the reassessment, see the February 2009 issue of News and Views.

The initial step of reassessment, which is gazetting of these products, occurred on 7 May 2009. The notification period is 40 working days to allow any person to make a submission on the intended reassessment. For further information, contact Lucy Johnston, Advisor (ACVM Standards-Animals) (lucy.johnston@nzfsa.govt.nz).

Antimicrobial Resistance Steering Group meeting

The annual meeting of the Antimicrobial Resistance Management Steering Group was held on 15 April 2009. Members were given an update on NZFSA's implementation of the recommendations made by the Expert Panel. The majority had been completed with only the establishment of a Technical Advisory Group and commencement of the baseline survey on antimicrobial resistance outstanding. The latter is subject to funding from the Ministry of Health.

Subsequent to this meeting, the funding for the baseline survey has been confirmed and NZFSA is consulting with relevant stakeholders on the survey protocol.

Fieldays at Mystery Creek

Three members from the Approvals and ACVM Group attended the 2009 Fieldays to educate companies marketing agricultural compounds, veterinary medicines and vertebrate toxic agents about the ACVM Act and to confirm compliance with its requirements.

To ensure compliance, NZFSA begins by providing information to companies that are marketing ACVM products and are unfamiliar with their obligations under the ACVM Act. Brochures on advertising and oral nutritional compounds were handed out to interested parties. (They are available on our website.)

High level of compliance noted

We were pleased to see a high degree of compliance displayed, especially by the larger veterinary medicine and agricultural chemical marketing companies. Last year we saw a reduction in the number of non-compliances and this year was much the same with virtually no issues.

We enjoyed meeting many industry people behind product marketing and seeing how products we registered are promoted and displayed.

(Photo above: Rebecca Fisher and Linley Thorburn in the stock trailer that was used this year to ferry people from the top car park to the Fieldays gate.)

Export Spray Programmes

NZFSA provides advice to support development or maintenance of Export Spray Programmes to facilitate export of food crops. This includes advice on appropriate export withholding periods (WHPs) to various industries. Without establishing an export WHP for a particular pesticide, it is unlikely that the pesticide will be included in the export programme.

These export WHPs are based on residue information that is often taken from residue data packages supplied to NZFSA to support registrations under the ACVM Act. The information is not released to external parties.

Reminder to ag chem registrants

If you do not wish your residue information used for setting export WHPs, advise us at the time of supplying the residue data with your application. To help you remember, a statement about this will be added to the initial screen letter.

OECD meetings

June -July, Paris

Warren Hughes and John Reeve will attend the following series of OECD meetings:

• Minor Use Expert Group

• Working Group on Pesticides (WGP)

• European Food Safety Authority (EFSA) and EC Coordination

• Government Only

• WorkSharing

• BioPesticide Steering Group.

Points of interest:

•John Reeve will become chairperson for the WGP meeting.

•New Zealand will present a paper to the WGP on meeting efficiencies. This is in response to the large number of meetings OECD countries could potentially attend and the recent global financial crisis.

•The EFSA and EC meeting is to discuss the EU’s move away from risk assessment to hazard assessment. This change is likely to have impacts on work sharing and possibly other regulatory outcomes.

Chinese delegation to visit New Zealand

A three person delegation from China’s Institute for the Control of Agrochemicals (ICAMA), which is our equivalent with respect to regulation of pesticides, will visit New Zealand in July. They wish to discuss a range of matters and to understand New Zealand’s regulatory environment.

Invigor8 Workplace Challenge

NZFSA’s ‘Fit for Life’ programme for all its employees includes the recent Invigor8 Workplace Challenge. Each team took the 8 week ‘virtual’ challenge of exercising enough kilometres to tour New Zealand. This was done in many forms -- walking, cycling, swimming, playing soccer, netball etc. The Approvals and ACVM Group team (pictured below) came third in the competition.

The intention is to run this challenge on an annual basis with the hope that employees will continue their personal exercise not only for the 8 weeks but throughout the year.

Workplace benefits

A recent corporate study shows that if an organisation takes a proactive approach to managing employee health it can provide the following benefits:

• reduce absenteeism

• reduce staff turnover

• reduce health risk behaviour

• reduce healthcare/ACC costs

• significantly increase overall workplace productivity. (See more on the Synergy Health website.)

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This page was last updated on 25 June 2009.