The Medicines Act 1981 regulates medicines, related products and medical devices in New Zealand. The Act ensures that the medicines and products used in New Zealand are safe and effective.
Medicines, related products and medical devices
- defines what a medicine is
- sets out:
- requirements for the approval, classification, manufacture, sale, distribution, advertising, prescribing and dispensing of medicines
- licensing requirements for the medicines distribution chain, including wholesalers and pharmacies
- requirements for the approval of related products
- post-market controls on medicines and medical devices.
Medicines cannot be advertised, sold or distributed without the approval of the Minister of Health (except in a few limited circumstances, which are described in the Act).
Some (narcotic and psychotropic) products that are used for therapeutic purposes are classified as controlled drugs. These products are therefore regulated under both the Medicines Act and the Misuse of Drugs Act 1975.
Administration of the Act
The Ministry of Health administers the Act and the regulations made under the Act such as the Medicines Regulations 1984, the Medicines (Database of Medical Devices) Regulations 2003 and designated prescriber regulations.
Medsafe (the New Zealand Medicines and Medical Devices Safety Authority) operates as a business unit within the Ministry of Health. Medsafe is responsible for administering most aspects of the Medicines Act 1981 and its associated regulations in New Zealand including:
- approval of new and changed medicines and related products
- audit and licensing of medicine manufacturers
- approval of clinical trials of new medicines
- classification of medicines
- surveillance and monitoring
- border control and enforcement
- administration of a database of medical devices in New Zealand
- oversight of medicine and medical device recalls.
For more information on their work, see the Medsafe website.
The Medicines Control team within the Ministry of Health administers controls on the distribution chain of medicines and controlled drugs in New Zealand, as well as managing related drug abuse containment issues.
The team is responsible for issuing licences under the Medicines Act, for people to:
- operate a pharmacy
- sell medicines by wholesale
- hawk medicines
- sell medicines by retail.
The team audits licensees regularly to ensure they comply with the Act.
The Act sets out:
- the legislative framework for prescribing prescription medicines
- the groups of health professionals able to prescribe.
In New Zealand all prescribers are also regulated under the Health Practitioner Competence Assurance Act 2003.
View the Prescribing statement which provides clarity for New Zealand health practitioners about the difference between the legal requirements for prescribing and the subsidisation of pharmaceuticals, including prescription medicines.