How to Register Medicinal Products in New Zealand: Regulatory Requirements Explained

 New Zealand offers a transparent yet stringent Regulatory environment for therapeutic and medicinal products. Regulated under the Medicines Act 1981 and Medicines Regulations 1984, entry into the market requires careful navigation of Medsafe’s processes, technical documentation requirements, and pharmacovigilance expectations.

This guide outlines the key steps, documentation formats, and submission pathways, for sponsors and Regulatory professionals targeting New Zealand.

1. Regulatory Oversight: Medsafe

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is the Regulatory agency responsible for evaluating the quality, safety, and efficacy of therapeutic products in New Zealand.

Medsafe’s functions include:

• Review and approval of new medicines
• Regulation of changed and related products
• Market surveillance and pharmacovigilance
• Enforcement of labeling, advertising, and distribution standards

2. Product Classification

Understanding product classification is essential for determining the appropriate Regulatory pathway.

Therapeutic products in New Zealand include:

• Prescription Medicines
• Restricted Medicines
• Pharmacy-only Medicines
• Over-the-Counter (OTC) Medicines
• Biologics and Biosimilars
• Related Products (e.g., herbal, homeopathic, vitamin-based)

3. Product Registration: Key Process & Updates

🔹 Step 1: Local Sponsor

A New Zealand-based sponsor remains mandatory and serves as Medsafe’s Regulatory liaison

🔹 Step 2: New Medicine Application (NMA)

Sponsors must submit applications via:

• Standard NMAs (for new chemical entities, indications, formulations)
• Abbreviated NMAs (leveraging approvals from EMA, US FDA, or TGA)
• Verification pathway (eligibility through approvals by two recognized authorities, per Medicines Amendment Bill proposed April 2025 — decision stage still under rule-setting)

🔹 Step 3: Submission Requirements

As of 2025, Medsafe still requires two identical electronic copies on CD/DVD, including full CTD Modules 1–5 (Modules 4–5 may be electronic if voluminous)

🔹 Step 4: Technical Evaluation & RFIs

Medsafe performs complete scientific reviews. RFIs may be issued and require a timely response.

🔹 Step 5: Approval & Gazette Publication

Successful applications receive “Consent to Market” and inclusion in the New Zealand Gazette.

🔹 Step 6: Post‑Market Requirements

Sponsors must maintain compliance via:

• Pharmacovigilance and adverse event reporting
• Annual reporting and variations
• Label changes and product recalls (if needed)

4. GMP Compliance

GMP compliance is essential for Medsafe approval. All manufacturing, packaging, and testing sites must hold valid GMP certificates from recognized authorities such as TGA, EMA, US FDA, or other PIC/S members.

Certificates must:

• Be current and site-specific
• Be included in CTD Module 1
• Cover all contracted sites (e.g., testing, labeling)

Post-approval, sponsors must maintain certification, report site changes, and comply with inspection requests.

5. Dossier Format: Common Technical Document (CTD)

New Zealand follows the ICH CTD format, consisting of five modules:

• Module 1: Region-specific (NZ-specific administrative and labeling info)
• Modules 2–5: Summaries, Quality, Non-clinical, and Clinical study data

Medsafe accepts:

• Full CTD submissions
• Abbreviated dossiers if the product is approved by EMA, USFDA, or TGA

6. Electronic Submissions

Medsafe mandates electronic submissions via CD/DVD. Key criteria include:

• Two identical electronic copies
• Structured folders (mirroring CTD)
• PDF format with bookmarks and hyperlinks
• Physical submissions must match the electronic format

  Without valid GMP compliance, product registration cannot proceed.

7. Sponsor Requirements

A New Zealand-based sponsor is required to:

• Submit and manage applications
• Respond to Medsafe’s queries
• Handle pharmacovigilance, recalls, and variations

This role may be filled by:

• A local affiliate of the MAH
• A contract Regulatory agent or third-party consultant

8. Estimated Timelines

Application Type	Estimated Review Time
Standard NMA	135–225 working days
Abbreviated Application	90–150 working days

Timelines vary based on dossier completeness, reference approvals, and response speed to RFIs (Requests for Information).

Need Expert Assistance?

Whether you're filing your first NMA or managing a post-approval variation, Regulatory entry into New Zealand can be streamlined with the right expertise. Our team offers end-to-end support—from product classification, Regulatory strategy, to Medsafe submission. Reach out to us for tailored guidance and full-spectrum Regulatory support.

Feedback: More emphasis on the product registration part.