Animal medicines

How are Agricultural Compounds and Veterinary Medicines (ACVM) regulated in New Zealand?

The New Zealand Food Safety Authority's (NZFSA) ACVM Group is responsible for approving veterinary medicines and other agricultural compounds used in the direct management of animals and plants.

Certain products need to be registered before they can be imported, manufactured, sold or used in New Zealand. Regulation is usually of trade name products (rather than the active ingredients) since the way products are formulated and used generally determines the level of risk.

The ACVM Group publishes standards and guidelines that provide details of information requirements for assessment of applications.

What is regulated?

Agricultural compounds are substances used to manage agricultural plants or animals, and include such things as poisons for possums, animal growth regulators, veterinary medicines and plant compounds. Operationally, agricultural compounds are considered in three classes:

These substances must be imported, manufactured, labelled, used, and sold in specified ways.

The ACVM Group has guidelines for Class Determination [11 pages, 53Kb, PDF] for determining if a tradename product is an agricultural compound.

What is not Regulated?

A range of compounds and substances are conditionally exempt from registration if they are used in accordance with conditions specified in the Agricultural Compounds and Veterinary Medicines (ACVM) regulations 2001. These include non-prescription first aid preparations, homeopathic compounds that make no specific therapeutic claims, and fertilisers. See the ACVM Group's website or contact the Group to find out if a particular compound or medicine is exempt, and what conditions are placed on that exemption. Note though that some compounds that are exempt from registration may require other approvals, such as an import permit from MAF and/or an approval given under the Hazardous Substances and New Organisms Act.

In addition, products used in home gardens are not regulated by the ACVM Act, unless they are used on food-producing plants.

Why are ACVM regulated?

Agricultural compounds and veterinary medicines are regulated to manage risks to animal welfare, trade in primary produce and biosecurity. The ACVM Act also allows for regulation to ensure that domestic food residue standards are not breached and that consumers have access to adequate information about agricultural compounds. Regulation covers importation, manufacture, sale, and use allows control of doses, methods and timing of applications, and withholding periods between the last application and harvest or slaughter.

Regulatory Process

There are two main types of regulatory approval:

In both cases a decision-making committee formed by the ACVM Group of the NZFSA will evaluate the information, and approve or decline the application. If an approval is given, conditions of importation, manufacture, sale and use (including labelling requirements) will be part of that approval.

The regulatory process evaluates the risks posed by the product to trade in primary produce, animal welfare, biosecurity or domestic residue standards. Applications are expected to come with a "data package" that provides all relevant information specified in the ACVM Group standards. The ACVM Group have also produced guidelines (in line with international technical requirements, such as VICH) that define the minimum requirements needed from research trials [11 pages, 37Kb, PDF] and the minimum requirements needed from animal safety trials [18 pages, 55Kb, PDF] to assess applications. More information on registration requirements is available on the ACVM Group website. For further information, talk to the ACVM Group about what is required for such a data package.

Where an agricultural compound or veterinary medicine has a significant new risk profile then public consultation may be necessary as part of the assessment process.

Other approvals

ACVM products involving new organisms or hazardous substances

If a new organism or a hazardous substance is involved, then a relevant approval from ERMA NZ is required before the ACVM approval is given. In these cases the ACVM Group's activity is subsequent to ERMA's. ERMA decides what controls it wants to impose, and then the ACVM Group place conditions on the trade name product to meet ACVM risk management needs. The ACVM Group manage different risks than ERMA and therefore there is virtually no overlap between the two. ERMA NZ has an introductory guide to hazardous substances [117 pages, 350Kb, PDF] and a guide on applying for a hazardous substance approval [4 pages, 74Kb, PDF], as well as other information sources on their publications web page.

To find out more about whether a particular compound or veterinary medicine may also involve a hazardous substance or new organism, talk to ERMA NZ or the ACVM Group.

Qualifying veterinary medicine

Where a veterinary medicine is, or contains, a new organism and is considered to present a low risk to humans and the environment, then it may be considered a "qualifying veterinary medicine" and be able to undergo a rapid assessment for release under the Hazardous Substances and New Organisms (HSNO) Act 1996. The HSNO Act assesses the risks to human health and the environment. This "qualifying veterinary medicine" process is intended to reduce duplication between the HSNO Act and ACVM Act regulatory processes.

Such rapid assessments are only for medicines that are very unlikely to have significant adverse effects on human health or any valued species, and would not be able to form a self-sustaining population that had adverse effects on people or the environment. An example would be a vaccine that is injected into muscles and imported as single-dose ampoules.

Rapid assessments require a decision to be made within 40 working days of receipt of the application, and as such would not be publicly notified applications. At this stage a decision on a rapid assessment application of a veterinary medicine can be made by the Chief Executive of ERMA NZ. There is the potential for the Chief Executive of the NZFSA to seek to make such decisions, but a request to do so has not yet been made. Regardless of who makes the decision, the information requirements and basis for making a decision will be the same. ERMA NZ has an information sheet on qualifying veterinary medicines [2 pages, 49Kb, PDF].

Rapid assessments can also be given if a veterinary medicine is required for an emergency or special emergency. See the What if a new organism is required for an emergency? section of this site for more information. To find out more about the rapid assessment process talk to ERMA NZ or the ACVM Group.

ACVM products involving prescription medicines

If a product contains a human prescription medicine, a relevant approval from the Director-General of Health is required before registration from the ACVM Group. The ACVM Group is able to provide advice in this area.

Animal ethics approval

If animals are used in testing for a research or provisional approval then an approval from an authorised animal ethics committee will also be required. The animal ethics committee will assess the potential adverse effects on the animals, whether the necessary information can be obtained by other means and whether the benefits of using animals outweigh any pain or suffering that may result from the testing. Animal ethics committees are managed by the Ministry of Agriculture and Forestry (see the Animal ethics section of the Regulatory Wayfinder).

How can I find out about decisions?

Regulatory updates are provided on the NZFSA website. You can also register on the website to receive e-mails advising you of new regulatory information and decisions.

Time and Cost

The ACVM Group has a range of application types depending on whether they involve new active ingredients or are the same as, or similar to, other registered products. Costs for applications vary depending on the type of application. Where the application involves assessment of data there is an hourly charge for the assessment. The current fees can be found on the ACVM Group's website, along with the processing times (generally up to 40 working days).

An application to ERMA New Zealand for rapid assessment of a qualifying veterinary medicine costs $500 and application processing takes 40 working days. If a standard application for release of a new organism is required then application charges will start at $25,000, with a processing time of 100 working days. For an application involving a hazardous substance then application charges can range from $3000 - $15,000 (or a charge is negotiated if the application is particularly complex or contentious). See ERMA's information sheet on costs [2 pages, 96Kb, PDF].

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