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The Medicines Act 1981 is the cornerstone of New Zealand's Regulatory framework for medicinal products. Administered by Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, the Act governs the manufacture, importation, distribution, and sale of medicines and medical devices within the country. Its primary objective is to ensure that all therapeutic products are safe, effective, and of high quality, thereby protecting public health.
Key Provisions of the Medicines Act 1981
- Definition of Medicines: The Act defines a "medicine" as any substance or article, other than a medical device, that is manufactured, imported, sold, or supplied wholly or principally for administering to one or more human beings for a therapeutic purpose.
- Regulation of Medical Devices: It also encompasses the regulation of medical devices, ensuring that they meet safety and performance standards.
- Licensing and Approval: The Act outlines the requirements for obtaining licenses to manufacture, import, or distribute medicines and medical devices.
- Advertising Restrictions: Section 20 of the Act prohibits the advertising of unapproved medicines, even to medical professionals, with penalties including fines up to NZ$100,000 and imprisonment for up to 6 months.
Recent Amendments and Updates
In 2025, the New Zealand government introduced the Medicines Amendment Bill to amend the Medicines Act 1981. The primary objective of this Bill is to improve access to medicines by reducing barriers currently present in the Act.
Key Features of the Medicines Amendment Bill:
- Verification Pathway: The Bill introduces a 'verification pathway' allowing medicines to be approved for distribution in New Zealand if they have been approved by two recognized overseas jurisdictions. This aims to expedite the approval process for medicines that are already deemed safe and effective internationally.
- Expanded Prescribing Rights: It expands the prescribing rights to include nurse practitioners and authorized prescribers for unapproved medicines funded by Pharmac, thereby increasing the accessibility of medicines to patients.
- Equity Considerations: The amendments aim to improve access to medicines for all New Zealanders, particularly benefiting vulnerable and high-needs communities, including older people, Māori and Pacific peoples, disabled individuals, and those with chronic or rare health conditions.
Regulatory Authorities
- Medsafe: Operates within the Ministry of Health and is responsible for administering the Medicines Act and its associated regulations. Medsafe oversees the approval of new medicines, licensing of manufacturers, clinical trials, pharmacovigilance, and enforcement activities.
- Pharmac: New Zealand's pharmaceutical management agency, responsible for determining which medicines are funded by the government and negotiating prices with suppliers.
Looking Ahead
The Medicines Amendment Bill reflects New Zealand’s efforts to modernize its regulatory framework, streamline medicine approvals, and enhance patient access to safe and effective therapeutics.
Ensure Compliance with Ease
Navigating New Zealand’s regulatory landscape can be complex. Freyr helps pharmaceutical and biotech companies streamline regulatory submissions, ensure compliance with Medsafe requirements, and accelerate market access.
Contact Freyr today to simplify your New Zealand Regulatory strategy.