Medicines for animals can contain hazardous substances and require approval before they can be imported or manufactured in New Zealand.
Veterinary medicines are used in the direct management of an animal. Animal nutritional and animal care products are covered by a group standard approval.
Veterinary medicines that are hazardous substances require approval under the Hazardous Substances and New Organisms (HSNO) Act before they can be imported or manufactured in New Zealand. To find out whether your product is approved or how to get it approved, follow the steps below.
Step 1: Determine whether the product is a hazardous substance
If your substance does not contain a new active ingredient you can determine the hazards yourself or we can determine whether it’s hazardous for you. Just apply for a section 26 determination.
Step 2: How will it be used?
For research and development, including field trials, a containment approval is required.
Importation or manufacture in a laboratory may be exempt from requiring a HSNO approval if it remains in there.
If you want to be able to use it freely in New Zealand, move forward to the next step.
Step 3: Is it already approved?
If your substance contains the same active ingredient as an approved substance and has the same classification and use as that substance, it may be covered by the existing approval. You can check whether your product may be covered by an existing approval by looking at our register. It may also be covered by a group standard.
Formal advice on whether or not your product is also already covered by an existing approval in New Zealand is also provided as part of section 26 determinations.
If your product is not covered by an existing approval, an application for an approval must be made.
Step 4: What application do you need to make?
If your product contains active ingredients that are new to New Zealand, your substance may be eligible for rapid assessment if it meets the least degrees of hazard criteria. If your substance is not eligible for rapid assessment, a full assessment is required.
If your product contains active ingredients that are present in existing substances in New Zealand, it may be eligible for rapid assessment if it has a similar composition or has a reduced hazard compared to another substance that is already approved or meets the least degrees of hazard criteria.