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NOTE: This is an archived issue. The current issue of AgVetLink can be found at http://www.nzfsa.govt.nz/acvm/publications/agvetlink/
AgVetLink December 2002
Previous page | Contents | Next pageCodes of practice
A new code, The Code of Practice for the Use of Veterinary and Human Medicines in Research, Testing, and Teaching Organisations, sponsored by the Royal Society of New Zealand, has been approved under section 28 of the ACVM Act. This approval completes a number of years' work by senior scientists in universities, CRIs and private commercial organisations to provide a framework to manage the risks under the ACVM Act from the use of PARs and human medicines by non-veterinarian staff under indirect supervision. The code contains an appendix that provides guidelines for the preparation of operational instructions from the veterinarian to the non-veterinarian for the administration of the medicines.
Another code, The Code of Practice for the Use of Prescription Animal Remedies by Grooms Travelling with Horses by Air or Sea, has been developed by the Equine Branch of the New Zealand Veterinary Association. It is currently under assessment by the ACVM Group for approval by the Director General. This code is also the culmination of many years' development to manage risks in potentially high profile situations.
Eight codes (excluding the grooms code) have now been approved under the ACVM Act. Approved codes are the property of the owner or the sponsor, and anyone wishing to access or adopt an approved code should contact the owner. A register of approved codes containing the contact details of their owners may be found on the ACVM Group website at the following location: http://www.nzfsa.govt.nz/acvm/registers-lists/cop.htm
Antibiotic review
The ACVM Group is updating information surrounding the control of veterinary medicine usage now that the majority of the changes proposed by the Expert Panel and Steering Group have been effected.
The breakdown of sales figures supplied by registrants, along with our interpretation of the results to date, has been checked with the main industry groups and with representatives of the key user groups. We expect to have this information available this month.
The feedback from this process suggests that change has not been as quick to occur as we had previously thought, at least with users and prescribing veterinarians, although we are advised that the required changes have been made from 1 July 2002.
Because there has been considerable change in the area over a relatively short period of time, the ACVM Group is working with the NZFSA Compliance and Investigation team on a 'reality check' audit that will be carried out in the near future. The audit is intended to highlight any areas where further work is needed to effect the required changes. It is likely to concentrate on:
- products that have changed from OTC to prescription status all through the supply chain from the registrant to the user;
- the intensive farming industries and the use of prescriptions for in-feed medications;
- PAR products where the use has been limited, either by removing the opportunity for 'off-label' use by veterinarians or where the veterinarian isrequired to confirm the appropriateness of the product prior to use.
Policy development: agricultural security thresholds
The ACVM Group is working with MAF Biosecurity Authority to revise the thresholds relating to agricultural security. This is likely to have an impact on the information requirements for products in this area in the short term.
To date the ACVM Group has indicated that for plant compound products, there is no requirement for efficacy information or for information on plant safety. Indications from MAF Biosecurity are that they will require this in the future. If a product is being used to eradicate a pest or disease in New Zealand, MAF Biosecurity needs to be assured that it works - hence the probable need for efficacy information. They will also need to have an understanding of the effects on the host plant and, in some instances, depending on the use pattern, on off target plants as well.
This is a likely change to the current thresholds found in the Guidelines for risk assessment and hazard analysis under the ACVM Act 1997. As soon as the proposals are finalised they will be circulated to interested and affected parties for comment and advised via the website. Comments on this issue in the ACVM Act Amendment discussion paper will also be taken into account.
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