,
Greetings from
Freyr New Zealand
New Zealand is emerging as a high-opportunity market for pharmaceuticals, medical devices, consumer health products, food supplements, and Cosmetics. Companies planning drug registration in New Zealand must navigate a Regulatory system governed by the Medicines Act 1981 and Medicines Regulations 1984, while the government advances a new Medical Products Bill to modernize future regulation.
During this transition, Medsafe Regulatory requirements continue to evolve across clinical trials, pharmacovigilance, manufacturing, labeling, and advertising. Manufacturers entering the market must carefully manage compliance while aligning with updated Regulatory guidance.
Freyr provides New Zealand pharmaceutical Regulatory services and supports global companies with Regulatory intelligence, market entry planning, and compliance management, ensuring products remain aligned and competitive in the New Zealand market.
Industries We Serve in New Zealand
With a strong healthcare system, high Regulatory standards, and alignment with global authorities, New Zealand presents a promising opportunity for pharmaceutical companies expanding into the Asia-Pacific region. The Regulatory framework, overseen by Medsafe, supports safe and efficient drug approval in New Zealand.
However, navigating Medsafe Regulatory requirements, New Medicine Application (NMA) submissions, and sponsor obligations can be complex for new entrants.
Freyr offers comprehensive pharmaceutical Regulatory consulting in New Zealand, including Regulatory strategy, dossier preparation, Medsafe dossier submission, and lifecycle management, supporting efficient pharmaceutical market entry in New Zealand.
Medical devices in New Zealand are regulated by New Zealand Medicines and Medical Devices Safety Authority (Medsafe) as per the Medicines Regulations 1984, the Medicines Act 1981 and Medicines (Database of Medical Devices) Regulations 2003. While pre-market approval isn't necessary, listing the products in the Electronic Web Assisted Notification of Devices system (WAND) database within 30 days of commercial launch is necessary. Documentation proving safety and effectiveness, such as certification from recognized bodies like an EU Notified Body or Health Canada, may be requested by Medsafe.
In New Zealand, cosmetic products are regulated by the Environmental Protection Authority (EPA). The import and manufacture of cosmetic products in the country require manufacturers to meet the conditions laid down by the Environmental Protection Authority (EPA) New Zealand under the Cosmetic Products Group Standard. Entering the New Zealand market can be challenging for cosmetic manufacturers due to limited knowledge of cosmetic regulations and current market trends.
The New Zealand food and dietary supplements market is an established yet dynamic market, focusing on product differentiation as its key growth strategy.. Food Standards Australia New Zealand (FSANZ) is the statutory body in the New Zealand government health portfolio, which develops food standards for Australia and New Zealand. However, dietary supplements are regulated under the Dietary Supplements Regulations, 1985, which falls under the Ministry for Primary Industries (MPI) Food Act, 2014. Medsafe is responsible for governing the dietary supplement regulations and the Food Act.
Freyr Offerings
- Strategic Regulatory Consulting
- Regulatory roadmap for market access
- Regulatory Affairs & Regulatory intelligence
- Registration pathways and license management services
- Marketing Authorization Applications,
- New Medicine Application preparation and submissions
- Handling and maintaining notification process
- On-site training on the WAND (Web Assisted Notification of Devices) database
- End-to-end assistance with investigation of medical device adverse events
- Good Manufacturing Practice (GMP) and GLP
- Product Labeling and advertising support
- CMC NDA, ANDA, CTD, dealing with post-approval changes – SUPAC
- Regulatory Submissions and follow-up
- handling and maintenance including electronic documentation (21 CFR part 11)
- Preparation of SPCs, Pack inserts, Product rationale,
- Preparation of PSUR reports
- DMF compilation
- Medical writing
- Post-market Activities, Post Marketing Maintenance
Freyr Advantages
- Strategic local health authority contacts – with Medsafe
- Expert Regulatory team with 25+ years of strong foothold and proven global RA expertise
- Proactive and Collaborative approach
- Quick turnarounds and faster time-to-market
- Keeping abreast with region-specific legislation and Regulatory guidelines