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Registration

506 ACVM 03/05

REGISTERING PRODUCTS UNDER THE AGRICULTURAL COMPOUNDS AND VETERINARY MEDICINES (ACVM) ACT 1997

CLASS DETERMINATION – IS REGISTRATION REQUIRED?

The ACVM Group gets frequent queries from people about their obligations regarding registering 'agricultural compounds' (plant compounds, veterinary medicines and vertebrate toxic agents). The first step required is to find out if it is a product that must be registered under the ACVM legislation to be legally imported, manufactured, sold or used in New Zealand. Agricultural compound trade name* products fall into different ‘classes’ – some products must be registered, some are exempt, some are prohibited from use as an agricultural compound and others are irrelevant to the ACVM Act.

*Because the levels of relevant risks are closely associated with particular formulations and use, the provisions of the ACVM Act are focused on the regulatory control of ‘trade name products’. A trade name product is an agricultural compound (or veterinary medicine) identified and packaged under a trade name for a specified use or uses.

People are able to determine what class their product falls into by checking the ACVM Regulations 2001 or they can ask the ACVM Group to undertake this activity for them (at a cost). Information about the ‘class determination’ service is available on the website (www.nzfsa.govt.nz/acvm). If a trade name product falls into a class that requires registration under the ACVM Act, an application is then made to the ACVM Group. Applicants can ask the ACVM Group for confirmation about the class and about statutory obligations.

KINDS OF REGISTRATION APPLICATIONS

Provisional Registration (for research /development purposes)

A provisional registration is required before an applicant may undertake studies on animals or plants using a trade name product that:

• does not have a current registration or provisional registration; or

• has a current registration or provisional registration, but the intended study will not comply with the conditions of that registration.

OR

Registration (for selling the product)

There are several types of application for registration, and there are also applications to ‘vary’ an existing registration: The registration application types are:

• Registration for trade name products containing a new active ingredient that has not been previously assessed

• Registration for trade name products with a new risk profile for a known active ingredient

• Registration for trade name products that are identical to an already registered product

• Registration for a trade name product with a similar risk profile to an already registered product

• Registration for a trade name product with specified requirements.

Variations to a registration include changes to:

• formulation

• manufacturing: method, site, new or additional manufacturer

• shelf life

• additional target species or host

• additional claims

• change in dose regime or rate/timing

• new administration or application method

• change in the withholding period

• administrative matters, e.g. change of company name or address.

Applications are required for each of the above, but information requirements vary considerably. Requirements for each type of application are outlined in the relevant ACVM Registration Requirements document and include the requirements for technical data and/or scientific argument to support the application in regards to:

• the quality, purity and stability of the product

• the potential for residues

• the effectiveness for all therapeutic claims indicated in relation to the effect on animal welfare from inefficacy (for veterinary medicines and vertebrate toxic agents)

• the safety relating to target animals

• any possible negative impact on trade resulting from use of the agricultural compound in food production and crops.

The ACVM Group has also developed standards documenting the specific details of the information required to support an application. Accompanying guidelines provide advice on how to meet the standards. All of these documents are available on the website.

PROCESS

Data Assessment

Information supplied to support an application undergoes technical assessment to determine whether the information complies with ACVM Group requirements. The relevant standards and guidelines are used where available. Where these are not available, international common best practice is the guide. This Data Assessment Service (DAS) is offered by the ACVM Group and also may be performed independently, provided the assessment meets ACVM Group standards and the assessor is approved by the ACVM Group.

The DAS reports provide advice on whether the submitted data meets the registration standards and give an opinion of whether there are any potential risks that have not been addressed.

Prescreening

Before an application can be accepted as valid for processing, it must meet a number of criteria via a prescreen process. These criteria include:

• payment of the appropriate registration fee

• completion of an application form

• submission of relevant data and DAS reports.

A prescreen ensures that the application contains all information as identified on the application form checklist, and that this information is correct for the application type. On passing the prescreen process, the application is assigned to an Assessor, and the review and evaluation phase commences.

Review and Evaluation

The ACVM Group carries out a review and evaluation of the data assessment, addressing the risk areas set out in the ACVM Act (see our fact sheet entitled The ACVM Act). During this process we determine if the product meets the criteria for registration, and the conditions that should be placed on the registration to manage any risks identified.

The length of time this phase can take, as stipulated in the ACVM Act, is 25 working days plus an additional 30 days if the application must go through a 'public notification’ process. (Public notification is required whenever the public has not had an opportunity to comment on the risks posed by the product, e.g. applications for a new active ingredient or for a new use.)

All decisions are made within the context of existing policy. These policies are set via a process that is separate from the registration process. A committee (the Operational Policy Committee) has been established to enable operational staff to discuss policies and their implications.

Additionally, a Technical Consultative Committee (TCC) may review the assessor’s recommendations on a particular application. The TCC has been set up to provide scientific and technical support in the registration decision process. The TCC is not a decision-making body – it is a technical advisory body to the ACVM Group and advises primarily on areas of policy deficit.

Once the application has been reviewed and evaluated, it is submitted to the ACVM Decision Making Committee (DMC) with a recommendation.

Decision

The Director-General of Agriculture has delegated powers and functions to the individuals on the DMC. This committee decides whether or not the application should be approved. As required by the ACVM Act, the decision must be made within 15 working days.

Post decision

When an application is approved, the ACVM Group issues the appropriate registration documentation to the applicant. This includes:

• the certificate of registration, which contains a unique registration number and any conditions applied

• the approved Product Data Sheet, which details all the relevant information about the product, e.g. manufacturer, formulation, use

• the approved label content.

If a registrant fails to comply with the relevant conditions, the ACVM Group may revoke the registration of the product and/or apply appropriate sanctions.

Fees

In addition to the registration fee mentioned above, an annual fee for registered trade name products is prescribed in the Regulations under the ACVM Act. The ACVM Group will invoice all registrants in July of each year. Failure to pay this fee means that the registration may be cancelled and the registrant will be prohibited from importing or manufacturing the registered product until the fee and any penalty payment has been made.

For more information visit the ACVM Group website (www.nzfsa.govt.nz/acvm) or contact the ACVM Group directly at:

ACVM Group
New Zealand Food Safety Authority
PO Box 2835
Wellington, New Zealand
Phone: 04 463 2550
Fax: 04 463 2566

Disclaimer: This publication is intended only as a guide.
It is not a legal interpretation of the legislation discussed.