The legislation

You can view New Zealand's Acts and Regulations on-line on the Interim Website of New Zealand Legislation (select Statutes to see the Acts and Statutory Regulations to see Regulations). Copies of legislation can also be bought from government bookshops. Listed below are the Acts mentioned on the Regulatory Wayfinder (with icons identifying which parts of the Wayfinder they relate to), and others that may also be relevant to biotechnology in New Zealand.

Animal Welfare Act 1999

The Animal Welfare Act 1999, and Regulations associated with it, is the relevant piece of legislation if animal subjects are involved in the research.

Agricultural Compounds and Veterinary Medicines Act 1997

The Agricultural Compounds and Veterinary Medicines Act 1997 is the key piece of legislation for regulation of veterinary medicines. There are also several other pieces of legislation that are considered by the ACVM Group of the NZFSA in its work. These are the:

Among other things the ACVM Act addresses dose and timing of applications of agricultural compound and veterinary medicines, which affect residues in food.

Biosecurity Act 1993

The Biosecurity Act 1993 sets out the requirements and responsibilities for biosecurity clearance, inspection, surveillance, compliance and other issues associated with managing pests in New Zealand. See the FAQ for how the Biosecurity Act and Hazardous Substances and New Organisms Act relate to each other.

The Food Act 1981

The Food Act 1981 outlines the processes for making food standards and food regulations and the requirements for labelling and advertising, provides powers of enforcement and defines offences.

A range of other regulations also specify regulatory requirements for certain types of products and processing (such as dietary supplements, meat and dairy products). Descriptions of these can be found on the FSANZ and NZFSA in the Who is involved section of the Regulatory Wayfinder.

The Hazardous Substances and New Organisms Act 1996

The Hazardous Substances and New Organisms Act 1996 sets out the requirements for the assessment and decision-making criteria associated with approving hazardous substances and new organisms in New Zealand.

The HSNO Act is also relevant if the agricultural compound or veterinary medicine contains, or is, a hazardous substance or new organism.

Health Research Council Act 1990

The Health Research Council Act 1990 includes guidelines for approving ethics committees.

Human Assisted Reproductive Technology Act 2004

The Human Assisted Reproductive Technology Act 2004 has recently been enacted. This requires ethical review of human assisted reproductive technologies and human reproductive research which are not considered established procedures.

Human Tissue Act 1964

Human Tissue Act 1964 is relevant where cell or tissue samples are collected from humans. Note that this legislation is currently undergoing review.

Medicines Act 1981

Medicines Act 1981 and the Medicines Regulations 1984 are the key pieces of legislation for marketing medicines in New Zealand. Parts of the Misuse of Drugs Act 1975 and the Misuse of Drugs Regulations 1977 may also be relevant.

The Medicines Act controls which products may be legally sold and distributed as therapeutic products, where they can be manufactured, licensing and distribution requirements, and quality standards for medicines and their packaging.

The Medicines Act 1981 is also relevant if the agricultural compound contains a prescription human medicine.

Some other relevant New Zealand legislation

Health and Safety in Employment Act 1992

This Act promotes excellence in health and safety management through promoting the systematic management of health and safety. It requires that work place hazards be identified and steps taken to remove or reduce these hazards. The Occupational Safety and Health Service is the agency responsible for monitoring and overseeing workplace health and safety.

Local Government Act 2002

The purpose of this Act is to provide for democratic and effective local government that recognises the diversity of New Zealand communities. The Act provides a framework and powers for local authorities to decide which activities they can undertake and the manner in which they will undertake them. Local Government Online provides a portal to New Zealand local government.

Patents Act 1953

The Patents Act is currently undergoing review. A draft Bill was released for public consultation in December 2004. See the Minsitry of Economic Development's intellectual property pages on their website for up-to-date information.

Resource Management Act 1991

The purpose of this Act is to promote the sustainable management of New Zealand's natural and physical resources, by avoiding, remedying, or mitigating any adverse effects of activities on the environment. The Act governs the use and development of our land, air and water resources, concentrating on managing the environmental effects of human activities.

Building a new laboratory or factory will probably require applying for a resource consent under the Resource Management Act. See the FAQ for how the HSNO Act and Resource Management Act relate to each other.

In 2004/2005 the government undertook a review of the RMA to improve its operation. See the Ministry for the Environment website for more information on this.

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