Frequently Asked Questions
Q. What THERAPEUTIC PRODUCTS LEGISLATION currently applies in in New Zealand?
A. All medicines marketed in New Zealand must comply with the legislative requirements in force at the time. The principal pieces of legislation that regulate the use of therapeutic products in humans are the Medicines Act 1981 and the Medicines Regulations 1984 and their respective amendments.
The Medicines Act 1981 imposes controls on the manufacture and distribution of medicines and related products, the conduct of clinical trials and the advertising and sale of medicines, related products and medical devices. The Act also details provisions for enforcement of the legislation. The Medicines Regulations 1984 specify the detailed requirements for medical advertisements, prescribing and dispensing, licences, data sheets, and the manufacture, packing, labelling and storage of medicines and related products.
Q. How are Therapeutic Products categorised?
A. Products used for a therapeutic purpose are categorised
as medicines, related products, herbal remedies or medical devices. Definitions
of other categories (e.g. cosmetics, dietary supplements, herbal remedies, etc.)
are also provided in the legislation and official standards and are further
described in various guidelines.
Q. What is the definition of a Medicine?
A. The terms medicine and new medicine are defined under section 3 of the Medicines Act 1981.
A medicine is essentially a substance or article which is manufactured, imported, sold or supplied wholly or principally for a therapeutic purpose (qv). The term can include an ingredient used in the preparation of any therapeutic product. Except in the case of certain specified exemptions, the consent of the Minister of Health is required before a new medicine can be distributed in New Zealand.
If a product is administered to humans and contains a substance that exerts a therapeutic effect, that product is considered to be a medicine, irrespective of whether therapeutic claims are made on the label or in advertising material. For example, a product containing a hormone is a medicine, regardless of the purpose for which it is being promoted. In addition, any substance included in the First Schedule to the Medicines Regulations 1984 is a medicine when used for a therapeutic purpose.
A new medicine is a medicine for which the Minister of Health has not yet given consent to distribute. New medicines also include products which are referred to the Minister under section 24 (5) of the Act and any medicine which has not been “generally available” in New Zealand during the preceding 5 years. The term excludes medicines that were generally available before the commencement of the Act (i.e. grandfathered products). A product is a new medicine if additional active ingredients are added to an existing medicine or if active ingredients within an existing medicine are replaced.
The term therapeutic purpose is defined under section 4 of the Act. It includes treatment, prevention and diagnosis of disease, contraception, induction of anaesthesia and the cleaning, soaking or lubricating of contact lenses. It also includes alteration of the shape, structure, size or weight of the human body and otherwise prevention or interference with the normal operation of a physiological function. A product is considered to be intended for a therapeutic purpose if a therapeutic claim is stated or implied in the product labelling or promotional material, or where an active ingredient clearly has a pharmacological action. A statement that a product is intended to give relief from a disease or symptoms associated with a disease is likely to be a therapeutic claim. A statement relating to the normal nutritional, biochemical or physiological function of a substance is unlikely to be therapeutic claim.
The New Zealand Regulatory Guidelines for Medicines provide guidance on the interpretation of therapeutic purpose and the sort of claims that may be made for certain types of product.
Q. What are related products?
A. The term related product is defined under section 94 of the Medicines Act 1981. A related product is a product that is primarily a food, dentifrice or cosmetic but is claimed to be effective for a secondary therapeutic purpose. The consent of the Minister of Health is required before a new related product can be distributed in New Zealand.
The legislation does not require a related product to be manufactured in a factory licensed to manufacture medicines, but the manufacturer must comply with an appropriate standard of good manufacturing practice (GMP).
Examples of related products are given in the NZ Regulatory Guidelines and include:
- Antiseptic throat lozenges (n.b. fungicidal lozenges are restricted medicines)
- Fluoride toothpastes containing not more than 0.1% elemental fluorine (n.b. toothpastes containing more than 0.1% elemental fluorine are classified as pharmacy-only medicines)
- Antidandruff shampoos
- Antiseptics used for cleaning wounds, cuts, abrasions, stings, insect bites and superficial burns.
Q. What does the term Herbal Remedies mean?
A. The term herbal remedy is defined in section 2 of the Medicines Act 1981. A herbal remedy is a sub-category of medicine that does not contain a prescription, restricted or pharmacy-only medicine, and consists of a substance derived from plant material that has been dried or crushed or derived through any other similar process. It may also be an aqueous or alcoholic extract of the dried or crushed plant material or a mixture of that material with another inert substance.
The consent of the Minister of Health is not required for the distribution in New Zealand of a herbal remedy that is sold or supplied without any recommendation as to its use.
Q. What are Dietary Supplements?
A. The term dietary supplement is defined under regulation 2 of the Dietary Supplements Regulations 1985 and includes any edible substance, in a controlled dosage form, which is intended to supplement the intake of substances normally derived from food.
The boundary between a cosmetic or dietary supplement and a related product (i.e. having a secondary therapeutic purpose) is sometimes difficult to define. If a primary therapeutic claim is made for a cosmetic or dietary supplement the product becomes a medicine. The NZ Regulatory Guidelines provide guidance on the types of products which, when sold without any therapeutic claims and do not contain any substance listed in the First Schedule of the Medicines Regulations 1984, are considered to be cosmetics (e.g. antiperspirants, sunscreens, cleansers, etc.).
The NZ Regulatory Guidelines provide additional guidance on the categorisation of certain products, as follows:
- Although not actually administered to humans, pregnancy test kits are medicines.
- Spermicidal condoms and intrauterine devices (IUDs) containing copper or a hormone are medicines, whereas non-spermicidal condoms and other barrier-type contraceptives (e.g. diaphragms) are medical devices.
- In vivo diagnostic agents are medicines, while in vitro diagnostic products are medical devices (except pregnancy test kits, which are medicines).
- Substances used in dental surgery for filling dental cavities are medical devices.
- Medicated dressings where the medication has a curative function that is not limited to sterilising the dressing are medicines, whereas non-medicated bandages and other surgical dressings are medical devices.
- Radioactive materials used for a therapeutic purpose are specifically exempted from the medicines legislation.
- Animal remedies and foods that do not claim to have a therapeutic purpose are not medicines.
Q. How would I track down information about the regulatory framework in Australia?
Q. How do I learn more about the world body?
A. See http://www.wsmi.org