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Provisional registration and research approval

Following the commencement of the Agricultural Compounds and Veterinary Medicines (ACVM) Act 1997 and the Hazardous Substances and New Organisms (HSNO) Act 1996, the ACVM Group has reviewed the basis for criteria for provisional registration and provisional registration (generic research).

Under section 27(7) of the ACVM Act, a trade name product that is also a hazardous substance or new organism cannot be issued with a provisional registration unless approval for that substance or organism has been issued under the HSNO Act 1996. Although the intention behind this legislation was to manage the risks associated with research carried out with potentially hazardous substances, in practice this was found to create a barrier to carrying out certain agricultural research within New Zealand.

At the moment, the presence of a substance (or an ingredient in a product) with a potentially hazardous characteristic is sufficient to classify that substance or product as a ‘hazardous substance’. The fact that the product or substance may have:

• a concentration that would be too low to cause a negative effect; and/ or
• an intended use and administration that would not provide an opportunity for public or environmental exposure

is not taken into consideration at the classification stage of a hazardous substance but at a later stage when the setting of controls occurs. Applications for provisional registration (generic research) were found to trigger the HSNO hazard thresholds although the use/ administration of most of these products and substances (and the subsequent conditions of registration) were such that no additional risks were required to be managed. In effect, this meant that the majority of applications for provisional registration (generic research) were also required to apply for ERMA NZ approval and were subject to the subsequent costs without any additional benefit in risk management.

As a result of the review, the ACVM Group has dispensed with provisional registration (generic research). This will now be replaced by ‘research approvals’. A research approval does not require registration under the ACVM Act, so it is not subject to requirement 27(7). All applications, therefore, that would have been submitted as an application for provisional registration (generic research) should now be submitted as an application for research approval.

What is the difference between provisional registration and research approval?

The purpose of provisional registration is to enable an applicant to carry out trial work with a designated or trade name product (i.e. in a final formulation) in order to obtain further information (e.g. efficacy, safety, residue trials) on that product and to determine whether it should be registered. The trial work is intended to lead to an ACVM registration of the trade name product and is subject to section 27(7) of the ACVM Act.

The purpose of a research approval is to enable an applicant to carry out research or trial work not covered under a provisional registration issued under section 27 of the ACVM Act but where the sale of experimental animals, plants and their produce are proposed. The trial work is not intended to lead to an ACVM registration of the trade name product and is not subject to section 27(7) of the ACVM Act. This includes research or trial work:

• using substances or products that are not intended to be registered as trade name products in New Zealand;
• for preliminary investigation of substances, prior to determination of particular trade name product specification for registration;
• in which substances/products are used but the purpose of the trial work is for reasons other than to gather information about the substances/products (e.g. general physiological research);
• on registered trade name products that will be used in a manner not provided for in the current registration.

Research approvals will be issued by the ACVM Group (but it may be on behalf of other groups within MAF) to undertake such research or trial work. The research approvals will ensure that the proposed research or trial work will not result in unacceptable risks, in particular the risk of prohibited residues in primary produce or food products.

ERMA NZ will be notified of research approvals granted by the ACVM Group. Applicants should be advised that approval for research granted by the ACVM Group does not constitute an approval for a substance under the HSNO Act 1996. Applicants should seek approval from ERMA NZ directly if they believe that the substances/products they propose to use are hazardous substances or new organisms.

Information

The information requirements for research approvals are set out on our website ( www.maf.govt.nz/acvm/ ) and fees will remain the same as for provisional registration (generic research). Any additional information required can be obtained by contacting the ACVM Group directly.