Sunscreen regulation is set for a significant overhaul under the proposed Medical Products Bill (Bill), alongside a broader package of reforms to New Zealand’s medicines framework. The proposals aim to close gaps in the current regime, particularly around product performance and oversight of SPF claims, while also introducing more flexible, modern settings for access to and control of medicine.

The Ministry of Health is proposing to include a regulation-making power in the Bill to enable tailored regulation of ‘boundary products’ that sit in between categories - such as sunscreens, which fall between cosmetics and medicines. The first intended application of this approach is to regulate sunscreens, allowing them to be subject to selected medicines-related provisions without, in most cases, requiring full approval as medicines. However, despite anticipation and a lengthy period of consultation, the draft Bill has not yet been released, leaving stakeholders and industry waiting for clarity on these new regulatory settings.

The proposal is driven by concerns that the current framework does not provide sufficient assurance that sunscreen products meet their SPF and performance claims. Consumers rely on these products but cannot independently verify their effectiveness, and the existing regime relies heavily on complaints-based enforcement, with no requirement for ongoing testing or accredited laboratories. 

In practice, the proposed model adopts a tiered, risk based approach. Most sunscreens would be notified to Medsafe, with sponsors  self certifying compliance against applicable standards. Higher risk products (for example, those with novel ingredients or stronger therapeutic claims) may still be required to obtain Medsafe approval.

Other proposals under the Medical Products Bill

Apart from the proposal to create a boundary product category for products such as sunscreens, Associate Minister of Health Casey Costello also proposes broader policy decisions for the Bill, including:

• improved access to medicines by:
  • allowing all registered practitioners to supply pharmacy-only medicines when providing a health service;
  • improving the regulation of standing orders by enabling them to be issued by organisations and adding safeguards such as required expiry dates;
  • permitting off-label use of medicines through regulations and standing orders; and
  • enabling the bulk import and supply of unapproved medicines by licensed wholesalers, including in anticipation of demand;
• reducing harm from the misuse of medicines and controlled drugs through a more patient-focused system centred on harm reduction and patient-clinician relationships. The new system would introduce “supported medicines use” orders and “medicines access limitation” orders, which could restrict access to certain medicines or controlled drugs on a medical practitioner’s recommendation. The proposal also includes use of prescriber prohibition notices to prohibit a health practitioner from prescribing one or more medicines, or from importing, supplying, manufacturing or administering a controlled drug.
• modernising regulation of therapeutic use of controlled drug medicines by shifting regulation from the Misuse of Drugs Act 1975 (Misuse of Drugs Act) to the Bill. This would allow stronger action against misuse through higher penalties and a broader enforcement toolkit, while enabling operational requirements such as stocktaking and labelling to be updated to reflect best practice. However, illicit conduct relating to controlled drug medicines, such as smuggling and black-market sale, will continue to be treated as criminal matters under the Misuse of Drugs Act.

Timeline 

The new regime is expected to be enacted in late 2027 and rolled out in stages. Quick win, low risk changes (such as enabling after hours medicine collection via e lockers) could be introduced shortly after passage - and may even be fast tracked through interim amendments to the Medicines Act 1981 (Medicines Act). The core regime, including repeal of the Medicines Act, is expected to follow around two years after enactment. More complex and significant reforms, particularly medical device regulation, will be phased in over a longer horizon of approximately five to ten years.

Our thoughts

The proposed sunscreen model reflects a move towards a more flexible, risk aligned approach, with oversight scaled to product risk, claims and evidence. This should improve regulatory agility and better align compliance obligations, while also supporting closer alignment with Australia. The introduction of a “boundary product” category is also a sensible development and could have wider application over time. For example, it provides an appropriate category for products such as dermal fillers, specialised foods (such as certain infant formulas or adult liquid feeds), or other cosmetic products with therapeutic purposes (such as anti dandruff or anti acne treatments that may also address conditions like psoriasis or eczema), which currently sit uncomfortably within existing frameworks.

However, the reliance on sponsor self certification introduces some risk that non compliant products may enter the market, placing greater weight on Medsafe’s post market monitoring and enforcement. This is likely to increase administrative demands and uncertainty as to classification for certain products, particularly for those that may fall between notification and full approval.

More broadly, the reform package continues the shift towards a more permissive, system level approach to medicines regulation, consistent with recent efforts to improve access and modernise settings. This is balanced by a stronger focus on harm reduction and enforcement, including new tools to manage misuse and enhanced penalties (which are currently modest, at best). While this approach offers greater flexibility, it is also likely to increase regulatory complexity and raise compliance expectations for suppliers and practitioners.

Cabinet papers and further information on the proposals are available on the Ministry of Health website here.

Get in touch

Please get in touch with our team if would like to discuss what these proposals could mean for your business, including product compliance and labelling.

Special thanks to James Burnett and Juliet Bing-Harmon for their assistance in writing this article.