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Regulations for veterinary medicines are streamlined

1 November 2012

Regulations for veterinary medicines are streamlined

The Environmental Protection Authority (EPA) has streamlined the regulation of veterinary medicines by issuing four new group standards covering formulated medicines and active ingredients used in the manufacture of veterinary medicines and agrichemicals.

The standards were developed following applications by Agcarm and ARRPA, seeking a more efficient system of approval. Previously, veterinary medicines required individual approvals from the EPA. They are also regulated by the Agricultural Compounds and Veterinary Medicines (ACVM) Act administered by the Ministry for Primary Industries.

Now, importers and manufacturers can assign products or substances to the new standards, providing they meet the requirements.

“Veterinary medicines are highly-controlled and comparatively low risk in terms of potential harm to individuals and the environment,” according to the EPA’s General Manager Applications and Assessment, Sarah Gardner.

“This new suite of group standards is an example of reducing unnecessary compliance costs to industry.

“We regard the development of these standards as a win for industry and a win for New Zealand as it will allow the EPA to concentrate its work on higher-risk hazardous substances,” Mrs. Gardner said.

Group standards allow substances to gain approval whilst still ensuring that the risks to human health or the environment are effectively managed by a set of conditions. These standards include various conditions and restrictions to manage the risks posed by the substances throughout their lifecycle.

For example, the restrictions detail how a substance may be used, what information must be supplied with a substance or on the label, and how a substance must be packaged, stored, handled and transported.

These new standards will come into effect on 29 November 2012. To help importers and manufacturers understand and use the group standards, the EPA will be producing an information sheet which will be available by the end of this year.

The new standards can be read in full on the EPA’s website here and here.

Any hazardous substance that is imported, manufactured or used in New Zealand must have approval under the Hazardous Substances and New Organisms (HSNO) Act. Any veterinary medicine that is approved under these group standards also requires approval under the Agricultural Compounds and Veterinary Medicines (ACVM) Act before it can be used in New Zealand.


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