Greetings from
Freyr New Zealand
With a growing Pharmaceutical / Medical Device manufacturing sector, New Zealand seems to be the potential bet for manufacturers across the globe to commercialize their medicinal products and devices in the region. While doing so manufacturers must comply with the region’s regulatory authority –The New Zealand Medicines and Medical Device Safety Authority (MedSafe) and for medical devices they should list their products in the Web Assisted Notification of Devices (WAND), no later than 30 days of exporting. Though manufacturers are free from obtaining pre-market approvals to enter the region, the proposed legislation changes and the willingness of New Zealand government to overhaul its existing Regulatory system might deviate market entrants with unclear Regulatory requirements.
Freyr, as a specialized global Regulatory partner, assists foreign manufacturers to keep track of update Regulatory requirements in the region and provides end-to-end Regulatory services in New Zealand that span across:
Industries We Serve in New Zealand
Owing to prosperous economy, New Zealand is considered as a flourishing market for Pharmaceuticals. Manufacturers willing to distribute and market their medicinal products in New Zealand must get an approval from New Zealand Medicines and Medical Devices Safety Authority - MEDSAFE. The overarching regulations for medicinal products might become tough to decode for new market-entrants and Regulatory support from an expert may be required to devise market strategy.
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