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News and Views for October 2008: Issue 2

Survey to get your feedback

We are planning a postal survey to get your feedback on what we are doing. Some questions we intend to ask are:

• when do you find that notifications from us are most helpful?

• do you use the on-line information (and if not, why not)?

• do you find the on-line stuff useful?

• what do you think we could do better?

• when do you think we should hold workshops?

We would like your ideas on other questions to ask.
Send us your suggestions for the survey by the end of October.

Workshops turnout disappointing

Workshops on regulatory changes were held in Auckland on 15 and 16 October. Attendance was low, and we hope the survey mentioned above will help us to find out why and to plan better for next time.

A summary of the questions/answers from the workshops will be posted on the website (acvm/publications/workshop presentations) ASAP. In the meantime, see the next article for the answer to a question that came up at both workshops.

Do I need a Provisional Registration or a Research Approval?

If you intend to register a product but need to get more information for your registration application, you need a provisional registration to undertake trial work on animals or plants.

You need a research approval for research or trial work:

• using substances or products that you don’t intend to register in New Zealand

• for preliminary investigation of substances

• for general physiological research etc rather than to gather information about the substances or products

• for a ‘new’ use of a registered trade name product (ie a use not covered by the current registration).

Contaminants in veterinary zinc products could pose food chain risks

If you produce or import veterinary zinc oxide and/or zinc sulphate products, you must ensure levels of contaminants in the products are acceptable.

This issue is raised following a recent situation in Australia where high levels of lead in imported zinc oxide resulted in considerable tissue residues of lead in swine. Given the extensive use of zinc products in New Zealand, it is especially important to ensure animals are not being exposed to excess contaminants that could be a risk in the food chain.

Foot rot and facial eczema products must comply with specifications

For registered veterinary zinc products promoted for treatment of foot rot and facial eczema, heavy metal contaminant levels must comply with the specifications in Annex 2 (sections 2 and 3) of the ACVM Registration Standard and Guideline for the Chemistry of Veterinary Medicines.

You must have information available for inspection

To ensure compliance with these specifications, registrants may have to supply information to identify the contamination level of zinc oxide in registered products. If the product is manufactured in New Zealand, this could be at your regular GMP inspection. If the product is imported, a desk-top audit could be undertaken. In certain circumstances testing in New Zealand may be a condition of registration and you must have these results available for inspection.

Oral nutritional compound ingredients must be ‘fit for purpose’

For zinc in products that may be registered or exempt from registration as oral nutritional compounds, you must ensure the ingredient is ‘fit for purpose’. No limits are specified for contaminants in nutritional zinc products, but the specifications in Annex 2 (mentioned above) provide suitable guidance levels for you.

For more information about veterinary zinc, email Andrew Pearson (Advisor, MRL Standards).

Aminoglycoside review reminder

In response to the report of the Antimicrobial Resistance Expert Panel (30 August 2005) and the advice of the Antimicrobial Resistance Steering Group, NZFSA will review veterinary medicines containing antimicrobials in the aminoglycoside class.

Recommendations for aminoglycoside antibiotics

The Expert Panel and the Steering Group’s recommendations for products containing aminoglycoside antibiotics are:

• Evidence of synergistic effect and enhanced efficacy of mixtures of β lactam and aminoglycoside should be required at the time of their next registration.

• Oral aminoglycosides, alone or in combinations, should not be used to treat non-specific enteric infections in groups of food-producing animals. If used to treat gut infections, their selection should be confirmed by bacteriology and susceptibility testing.

Review to ensure recommendations are implemented

The aim of the review is to:

• pinpoint the products in the groups identified by the Expert Panel

• ensure there is adequate supporting evidence to justify their continued use in terms of synergistic effect and enhanced efficacy of mixtures of β lactam and aminoglycoside antimicrobials

• ensure oral amingoglycosides are not marketed for use to treat non-specific enteric infections in groups of food-producing animals.

There are good animal health and welfare reasons to retain injectable and topical aminoglycosides as prescription veterinary medicines. However, injectable combinations of aminoglycosides with β lactam antimicrobials will be included in this review. Topical preparations for use on skin, eyes or ears will not be included.

Reassessment will start 1 July 2009

Affected registrants should have been contacted last year regarding the intended reassessment. This time frame is to allow you to bring your products in line with the recommendations prior to the review.

Once the review commences there will be no time extensions given and any products that do not satisfy the Expert Panel's recommendations will have their registrations discontinued. You should submit applications well before the review commences to allow plenty of time to bring your products into conformance.

If you have a product that you feel may be affected and have not been notified, or if you want further information on the review and reassessment, email Lucy Johnston, Advisor (ACVM Standards-Animals).

Complaints of non-compliance always investigated

All complaints or allegations of non-compliance are investigated by the ACVM Group.

If there is a breach of the ACVM Act and/or ACVM Regulations 2001, our goal is to return the breach to compliance as soon as possible. 

What can the ACVM Group do about non-compliant products?

Several sanctions are available under the ACVM Act:

• declining clearance at the border

• suspending/withdrawing registration approval

• using prohibition notices, which detail requirements that must be met before normal business can resume

• recalling product for rectification, disposal or destruction if it does not comply with requirements of the Act and/or Regulations or the non-compliance would result in serious breaches to the ACVM risk areas (trade in primary produce, animal welfare, agricultural security, public health).

We do not shy away from prosecution where it is appropriate.

How do I find out about investigations?

We generally do not reveal the details of investigations until completed. However, information requests are assessed on a case by case basis with due consideration of the Official Information Act (and Privacy Act).

The results of prosecutions and other outcomes from investigations are published when it is legally possible and appropriate to do so as a deterrent to other potential offenders. We also publicise general compliance activity for the same purpose.

Product stewardship: Check for any weak links in your distribution chain

We have had many reports of products such as vaccines that are not being kept at the correct temperatures.

If you have any products that require special storage, make sure your distributors know! Why not get your sales reps to do spot checks when they are ‘doing the rounds’.

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Send us your suggestions for the survey.

This page was last updated on 24 October 2008.