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FAQ on Regulation under the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997

Do I need some kind of permit to import/manufacture/sell/use Product X in New Zealand?

If Product X meets the definition of an agricultural compound (below), authorisation under the Agricultural Compounds and Veterinary Medicines Act 1997 (ACVM Act) is required. The Approvals and ACVM Group of NZFSA is responsible for authorisation of ACVM products in New Zealand.

The definition of an agricultural compound in the ACVM Act is:

Any substance, mixture of substances, or biological compound, used or intended for use in the direct management of plants and animals, or to be applied to the land, place, or water on or in which the plants and animals are managed, for the purposes of:

a. Managing or eradicating pests, including vertebrate pests, or

b. Maintaining, promoting, or regulating plant or animal productivity and performance or reproduction, or

c. Fulfilling special nutritional requirements, or

d. The manipulation, capture, or immobilisation of animals; or

e. Diagnosing the condition of animals; or

f. Preventing or treating conditions of animals; or

g. Enhancing the effectiveness of an agricultural compound used for the treatment of plants and animals; or

h. Marking animals;

and includes any veterinary medicine, any substance, mixture of substances, or biological compound used for post-harvest pest control or disinfestation of raw primary produce, and any substance, mixture of substances, or biological compound declared to be an agricultural compound for the purposes of this Act by Order in Council made under subsection (2).

Veterinary medicine means any substance, mixture of substances, or biological compound used or intended for use in the direct management of an animal.

What if I am not sure if Product X is an agricultural compound?

The intended purpose of a product must be to directly achieve one of the purposes listed in the definition above. If the intended purpose fits the definition of an agricultural compound, then Product X is considered to be an agricultural compound.

The ACVM Group has a set of guiding principles that are used to determine if a trade name product (TNP) is an agricultural compound. If you are not sure about Product X, read through this information. Also, you can request the Approvals and ACVM Group to determine the status of Product X. (There is a fee for this service.)

Product X is an agricultural compound—what happens next?

All ACVM products require authorisation of some kind.

ACVM products that require individual assessment and approval must be registered before they are imported, manufactured for distribution, sold or used in New Zealand. This is to ensure that the products meet certain standards and do not pose unacceptable risks to:

• trade in primary produce

• animal welfare

• agricultural security

• public health.

Registration is also to ensure that the use of products does not breach domestic food residue standards and that sufficient consumer information is provided on the label so the product can be used safely.

Some ACVM products have already been assessed as a group and are considered to be exempt from registration if they are used according to conditions specified in the Agricultural Compounds and Veterinary Medicines (ACVM) Regulations 2001. Check the Regulations because the range of exempted products is extensive. You can also check the NZFSA website or contact the Approvals and ACVM Group to find out if Product X is exempt, and what conditions are placed on that exemption.

There are other kinds of authorisation as well, eg special circumstances permits, listing as GRAS (generally recognised as safe).

Product X must be registered—what should I do?

To register Product X:

• gather required information

• lodge an application with the Approvals and ACVM Group.

Information requirements, application forms and guidelines for the three types of agricultural compound products (agricultural chemicals, veterinary medicines and vertebrate toxic agents) are on the NZFSA website.

Is all this information really necessary?

All information must be provided in an application when it is lodged. However, before submitting an application, you may apply to the Group to waive the requirement for particular information if that information is:

• not relevant to the particular application (you must present a case to explain why the information is not relevant or why some other information would be more appropriate or more relevant) or

• in the public domain (you must provide the information or specify where the information can be readily found) or

• already held by the ACVM Group (if you wish to cross-reference information that is held on some other TNP, you must be specific about which TNP and what information is being referenced, and make the connection to your product. If the information being referred to is under data protection, you must obtain a letter of authority from the owner of the data stating that permission is granted to the Group to consider the information in regard to your application).

Waivers must be provided with an application when it is lodged. For more information, refer to the website: ACVM Guidelines for Information Waivers.

What if my product information is confidential?

All information submitted to the Group is held subject to an obligation of confidentiality to the supplier of that information. However, registration is a public process and information that is not specified as commercially sensitive/confidential will be public. To satisfy the provisions of the Official Information Act, all information submitted to the Group must be identified as confidential, commercially sensitive or be provided in a form that can be released into the public arena.

Will my data be protected?

To implement the General Agreement on Tariffs and Trade: Trade-Related Aspects of Intellectual Property Rights (GATT:TRIPS) agreement with respect to data provided in an application to register a product with an innovative active ingredient, the ACVM Act provides legislative protection for confidential supporting information (CSI). If data protection applies, the CSI will not be supplied to anyone outside the Group for any purpose without the “owner’s” approval.

What if I am not in New Zealand?

Any person can apply to register a product. If you are overseas, you must nominate a New Zealand agent who has legal obligations under the Act. We require a letter giving authority to the agent. (See the application forms and guidelines for details.)

What are my legal obligations?

The Approvals and ACVM Group assesses applications in light of the ACVM Act, its Amendments and Regulations when registering a product. You should be aware that, as a product registrant, you will have have legal obligations under this and other Acts. Other relevant legislation includes:

• Hazardous Substances and New Organisms (HSNO) Act 1996 and its Regulations

• Biosecurity Act 1993

• Fair Trading Act 1986 and the Consumer Guarantees Act 1993

• Health and Safety in Employment Act 1992

• Animal Products Act 1999

• Animal Welfare Act 1999

• Medicines Act 1981 and its Regulations 1984

• Food Act 1981 and its Regulations 1984.

Please note that, under the HSNO Act, an agricultural compound trade name product (TNP) that is a hazardous substance or contains new organisms, including genetically modified organisms (GMOs), cannot be registered unless it has prior substance approval from the Environmental Risk Management Authority (ERMA NZ). (See the application guidelines for details.)

If you have any questions, contact us.

This page was last updated 23 January 2009