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Te Pou Oranga Kai O Aotearoa

 
 
 

NOTE: This is an archived issue. The current issue of AgVetLink can be found at http://www.nzfsa.govt.nz/acvm/publications/agvetlink/ 

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Policy development on prescription animal remedies (veterinary medicines) status

Under the ACVM Act all products used to manage animals are veterinary medicines. Veterinary medicines that are medicines or drugs will be known as animal remedies to distinguish them from non-medicinal products such as feeds or dietary supplements. If animal remedies are subject to prescription, they will be classified as prescription animal remedies (PAR).

Recent issues involving the control and sale of prescription animal remedies have prompted a review of the criteria and rationale that places products into the ‘prescription’ category. The existing criteria have been reviewed and the following has been adopted.

An animal remedy will be required to be under prescription if:

  • the formulation includes a drug that is a controlled drug within the meaning of the Misuse of Drugs Act 1975, e.g. morphine, pethidine;
  • there is the possibility of acute or long-term toxic effects or development of hypersensitivity in humans, e.g. streptomycin, DMSO;
  • animal safety or welfare may be threatened, e.g. succinyl choline;
  • the remedy could mask disease, e.g. Brucella ovis vaccine;
  • use demands a veterinary diagnosis and or monitoring of the animal’s response, e.g. iodine, copper, corticosteroid, anaesthetics;
  • the administration requires the skill of a registered veterinarian to manage animal welfare concerns, e.g. intrauterine, intra-articular administration;
  • there is an increased risk of development of bacterial resistance to antibacterial agents used in human or veterinary medicine;
  • the remedy contains a human medicine, or a pro-drug of that human medicine that is available only on prescription unless specifically exempted by the Ministry of Health;
  • directions for sale and correct use of the animal remedy cannot be adequately conveyed by the product labelling and must be used by or under the control of a registered veterinarian;
  • a remedy is to be used under a national scheme to monitor, control or eradicate disease;
  • indescriminate use of a remedy is a threat to trade, and market access requirements require prescription use and control, e.g. hormonal growth promotants, antibiotics.

 

Workloads

We wish to advise you that all staff of the ACVM Group are currently ‘snowed under’ with applications lodged before the implementation of the ACVM Act. There has been an enormous increase on individual workloads, and there may be some time delays in advising you about your applications. We ask that you be patient at this time of legislation change. We are devoting as much time to application work as possible, including evenings and weekends. We do appreciate your cooperation.

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New Zealand Food Safety Authority
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Wellington
NEW ZEALAND

Phone: +64 4 894 2500
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