The article highlights the key points related to the regulatory framework for healthcare products in New Zealand.
Table of content
The Medicines and Medical Devices Safety Authority (Medsafe), New Zealand’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the regulation of therapeutic products allowed for marketing and use in the country. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved to ensure compliance.
At the same time, the authority reserves the right to make changes to the guidelines and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Introduction
This document outlines the regulatory framework for therapeutic products in New Zealand, forming part of the Guidelines on the Regulation of Therapeutic Products in New Zealand (GRTPNZ). Medsafe as a regulatory authority has developed these guidelines to assist the industry in adhering to legislative and regulatory requirements for marketing therapeutic products within the country.
Legislation
First of all, the document outlines the scope of legislation relevant to the regulation of therapeutic products (medicines, medical devices, and related products) in New Zealand.
Primary Legislation
The principal pieces of legislation governing therapeutic products include the Medicines Act 1981, the Medicines Regulations 1984, and the Medicines (Database of Medical Devices) Regulations 2003. These laws lay the foundational framework for the regulation of therapeutic products.
Additional Regulatory Controls
Various additional legislative instruments impose controls on specific types of therapeutic products and related activities:
- Medicines (Approved Laboratories and Analysts in Charge) Notice 2000
- Medicines (Related Products (Exempted Foods)) Regulations 2003
- Misuse of Drugs Act 1975 and associated regulations
- Psychoactive Substances Act 2013 and associated regulations
- Hazardous Substances and New Organisms (HSNO) Act 1996
- Contraception Sterilisation and Abortion Act 1977
- Electricity (Safety) Regulations 2010 and Electricity Act 1992
- Health Practitioners Competence Assurance Act 2003
- Radiation Safety Act 2016
- Human Tissue Act 2008
- Health (Needles and Syringes) Regulations 1998
- Dietary Supplement Regulations 1985
- Fair Trading Act 1986
- Sunscreen (Product Safety Standard) Act 2022
Types of Therapeutic Products
The document further provides the definitions and distinctions among various therapeutic products, including medicines, herbal remedies, related products, and medical devices, explaining the main concepts used.
Therapeutic Purpose
Therapeutic products are the ones intended for use in or on humans to achieve a therapeutic purpose, as defined by section 4 of the Medicines Act.
These purposes include:
- Preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for a disease or injury.
- Influencing, inhibiting, or modifying physiological processes.
- Testing susceptibility to diseases.
- Controlling or preventing conception.
- Testing for pregnancy.
- Investigating, replacing, or modifying parts of the human anatomy.
Indicators of a therapeutic purpose include the presence of pharmacological, immunological, or metabolic actions, explicit therapeutic claims, and the inclusion of ingredients known for their therapeutic effects.
Medicines
Medicines, as defined in section 3(1) of the Medicines Act, are products exerting effects primarily through pharmacological, metabolic, or immunological means when administered to humans. Radiopharmaceuticals are regulated separately under the Radiation Safety Act 2016.
It is also important to mention that certain products meeting the definition of medicine are excluded from regulation under the Medicines Act, including:
- Dentifrice products
- Anti-dandruff hair products
- Anti-acne skincare products
- Some barrier creams and anti-bacterial skin products
Herbal Remedies
Herbal remedies are a subset of medicines defined in section 2 of the Medicines Act. They consist of substances derived from plant material, either dried or processed into extracts or mixtures.
Herbal remedies are exempt from the medicines approval process if provided by a natural practitioner to a known patient and labeled appropriately without making specific therapeutic claims.
Related Products
Related products, as defined in section 94 of the Medicines Act, are primarily foods, dentifrices, or cosmetics that also claim therapeutic use. These products must not contain prescription, restricted, or pharmacy-only medicine ingredients.
Examples include antiseptic throat lozenges and antiseptics for wound care.
Medical Devices
Medical devices, defined in section 3A of the Medicines Act, are instruments or articles used primarily on humans for a therapeutic purpose without exerting their principal intended action through pharmacological, metabolic, or immunological means. The authority provides further information about these products via its website.
In addition to the above, the authority encourages the parties involved to get in touch in case of any concerns regarding the regulatory nature of a product in question, as well as to determine the specific pathway to be followed.
Conclusion
In summary, the present guidance issued by Medsafe provides a general overview of the existing legal framework for various types of healthcare products intended to be placed on New Zealand’s market. The document outlines the key types of products and emphasizes their distinguishing features.
How Can RegDesk Help?
RegDesk is an AI-powered Regulatory Information Management System that provides medical device companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Global expansion has never been this simple.
