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News and Views for May 2009

What makes a complete application?

If you want to minimise costs and delays, make sure you submit an application for registration that includes the following:

1. Cover letter

• Clearly identify:

- what you are applying for, even if it seems obvious to you

- what product(s) you are cross-referencing (if any)

- what waivers you are requesting for information and/or for time, eg if you want an information waiver for safety or a time delay in registration to meet a seasonal market

- what ACVM data assessment services you want to use (if any)

- what method of payment you have chosen (if requesting an invoice, make it clear who should receive it).

• Address any issues or non-conformances raised in the data assessment reports you are including with the application.

• Provide a list of information supplied with the applications, eg dossiers, CD-ROMs, DVDs.

2. Product data sheet (PDS)

The signed PDS needs to be completed in FULL. Use the guideline to help you.

3. Copy of product label content

4. Additional documentation

• Provide copies of any required ERMA and Biosecurity New Zealand approvals.

• All veterinary medicine applications (except B3s) must include copies of current GMP certificates for the responsible manufacturer and the manufacturers of the formulated product.

• Include letter of authorisation (if required for NZFSA to access information owned by another party or under data protection or to authorise an agent to act on your behalf).

5. Data volumes as per relevant information requirements documents

• These should have a comprehensive table of contents, dividers, pagination and tags.

• All data packages must be provided in full—summaries are not enough.

6. Overall application summary

• Each application must have an overall summary. This document, which is in addition to the cover letter, should summarise the main aspects of the whole application.

- It should say what data is presented and how it supports the label efficacy claims, safety, shelf life, withholding periods and any other relevant information.

- It should include references to relevant documents, eg safety in neonates is supported by Study xyz.

- It is up to you to draw conclusions for the relevant risk areas (although NZFSA will draw conclusions about market access issues).

• The summary should also address any required areas not covered and provide reasoned argument to support data gaps -- don’t just ask for the requirement to be waived.

GMP current certificate required

All registration applications (including renewals) for veterinary medicines (except B3) that are not manufactured in New Zealand must include a current good manufacturing practice (GMP) certificate. This also applies to Australian manufactured products because information on the APVMA website is not current and not easily accessible.

Speaking of applications—no queue jumping

From now on, applications for provisional registration and research approval will be handled in the same way as applications for full registration. They will be put in the queue when they arrive and will take their turn through pre-screen, assessment and decision making. There will be no queue jumping.

Although there is no statutory timeframe for processing provisional and research applications, we aim to deal with them in the timeframe set down for full registration.

If you intend to submit a provisional registration or research approval application, make sure you allow sufficient time for the approval process. Plan ahead!

Copper toxicity and palm kernel extract

An article published in Gribbles Veterinary Newsletter, Labtalk, highlighted the potential for sheep and cattle to develop chronic copper toxicity if copper supplementation is not done judiciously when concurrently fed with feed containing palm kernel extract (PKE). The copper content in PKE is 20mg/kg dry matter, which is twice the daily requirement for cattle and four times that of sheep. PKE-associated copper poisoning, leading to deaths in dairy herds, has been reported overseas. Selenium and zinc content in PKE are also high.

We advise the pharmaceutical industry to consider the PKE content in feed when investigating adverse events relating to mineral toxicity.

Changes to veterinary medicine classification system

Plans are afoot to change the terminology used to classify veterinary medicines. The term ‘prescription animal remedy’ (PAR), which was relevant under the old Animal Remedies Act 1967, and the existing PAR classification system will be phased out and replaced with a new classification system.

Workshops to discuss changes

The changes were shared with over 300 members of the veterinarian community during a series of well-attended workshops held across the country throughout March and April. (A further workshop is scheduled for veterinarians in the Wellington region on 25 May.) The workshops, jointly hosted by the New Zealand Food Safety Authority (NZFSA), the Veterinary Council of New Zealand (VCNZ) and the New Zealand Veterinary Association (NZVA), provided opportunities for veterinarians to put forward suggestions to refine the classification system.

NZFSA’s ACVM programme manager Warren Hughes, who participated in all the workshops, said the proposed changes to the existing PAR classification system were generally accepted by the veterinary profession. He acknowledged that there are still some veterinarians who strongly oppose any change, particularly those aspects that would impose an obligation on veterinarians to provide written authorisations in lieu of dispensing the products themselves.

New classification system for registered products

Some changes in the management of veterinary medicines are not adequately provided for in the existing PAR system, such as products used for biosecurity purposes, and conditions on products are often misrepresented by the PAR classification system. The proposed system aims to better manage the diverse range of veterinary medicines now available in New Zealand.

Under the proposed scheme, Class A will replace PAR Classes I and II, but these products will still require veterinary authorisation for sale and use. Class B will replace PAR Class III, and a new Class C will be created for products that are used within a closed programme, eg national emergencies such as an equine influenza or foot and mouth disease outbreak.

NZFSA is still consulting over the proposed terminology, so the terms Class A, B and C are not yet set in concrete.

The proposed classification system has been developed by NZFSA in consultation with an AVMAC industry working group and will apply to registered trade name products only. Registered veterinary medicines that are currently restricted under the PAR classification system won’t need to be reassessed unless there is a change in status, and the rules governing the classification of products (operational interpretation 182) will not change.

Transition time to allow label changes

The change in terminology is likely to commence later this year. Registrants won’t be expected to change product labels immediately to comply with the new terminology so, for a period of time, old and new terminology will be in use. During this transition the PAR classes will be synonymous with the new terminology.

You can download a document explaining the proposed changes from our website. Your feedback is welcome (deadline 1 June 2009).

Antibiotic sales reports every two years

We collect antibiotic sales data from registrants every year. In the past, we have written a report on the data every year as well, but reports will be provided on a two-yearly basis from now on. This will not affect the annual collection of data.

Teat sanitiser testing

Recently we have had several enquiries about 'protocol A' mentioned in the Registration Standard and Guideline for Efficacy of Teat Sanitisers. Protocol A describes a suitable laboratory protocol for pre-clinical testing for efficacy of teat sanitisers using excised teats. The protocol is accessible only through the description in the Journal of Dairy Science 61 (7) 951, 1978, and is not available as a separate document elsewhere.

Registrants should note that Dairy NZ offers an analytical service for lab-based assays to determine the ability of teat sanitiser preparations to kill common mastitis causing pathogens. See "Teat Sanitiser Capability".

Some teat sanitiser labels include the statement “Passed NZ Teat Sanitiser Protocol A (1997)” or “NZ Teat Sanitiser Protocol A (1998)”. These statements refer only to Dairy NZ’s teat sanitiser capability test and the inclusion of the statement is not a requirement under the ACVM Act.

The guideline also refers to the American National Mastitis Council's recommended protocol for determining efficacy of a postmilking barrier teat dip based on reduction of naturally occurring new intramammary infections. This is the guideline for use in field studies for postmilking teat sprays.

Codex meeting summary

April, Beijing

The New Zealand delegation to the 41st Codex Committee on Pesticide Residues (CCPR) Meeting included three officials from NZFSA and one from industry.

MRL recommendations

• about 280 maximum residue limits (MRLs) were recommended for adoption as Codex MRLs (CXLs) -- all except 17 of these were new MRLs proposed by the Joint FAO/WHO Meetings on Pesticide Residues (JMPR) in 2008 and advanced using the ‘fast track’ procedure

• about 85 MRLs were not advanced because of acute dietary intake concerns (they are pending further information and/or re-assessment by JMPR)

• 80 CXLs or proposed MRLs were recommended for revocation or withdrawn, either because they were no longer supported or because no further information was available to resolve acute intake concerns identified by JMPR.

MRL issue with trade implications for New Zealand

The matter of Codex EMRLs (environmental maximum residue limits) in relation to Aldrin/Dieldrin, Chlordane, DDT, Endrin and Heptachlor was raised in light of the decisions taken by the Stockholm (POPs) Convention to outlaw or restrict the use of these compounds. While the committee noted the Stockholm Convention related to use and the EMRLs are there to cater for historical use, it did agree to collect monitoring data from countries to determine whether the current levels are still appropriate. This has some important trade implications for New Zealand, so next year’s meeting will be of interest.

Current work in addition to MRL setting

The main areas are:

• reviewing its risk analysis principles

• revising the Codex Classification of Foods and Animal Feeds

• revisiting its policy on setting MRLs only for processed food where the raw agricultural commodity concentrates in processing, eg tomatoes processed into tomato paste

• developing guidance on how to facilitate Codex MRLs for minor uses (OECD is discussing facilitating national MRLs for minor uses).

Compliance update: pesticides ‘slice of life’ review

The Approvals and ACVM Group contracted NZFSA’s Compliance and Investigation Group (CIG) to conduct a ‘slice of life’ review of the pesticides industry. This type of review provides us with a preliminary overview of activities in an industry sector that has not previously been part of a compliance or monitoring programme.

The CIG reviewer surveyed a sample of importers, manufacturers, distributors and users of agricultural chemical pesticides in order to ascertain compliance with ACVM requirements. We are pleased to report that the review indicates substantial compliance with requirements. Only one non compliance was identified. A summary of the review is available on our website.

Compliance update: border control

A recent 1:10 check of registered trade name products coming into New Zealand showed a high level of compliance to ACVM requirements. The next 1:10 check, which is planned for next year, will include equine and aquatic products as well as items like pet foods, oral nutritional compounds and fertilisers.

Compliance update: Fieldays

Three of our compliance team (Linley Thorburn, Lucy Johnston and Rebecca Fisher) will attend Fieldays in June. As well as providing information, they will be checking labels and advertising/promotional material to make sure ACVM requirements are being met. (Nearly every year some products at Fieldays have to be withdrawn from sale because their label claims and/or advertisements are non-compliant.)

If you would like your product material checked for compliance before Fieldays, NOW is the time. Contact Linley Thorburn for details (linley.thorburn@nzfsa.govt.nz).

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This page was last updated on 6 May 2009.