Therapeutic & Natural Health Products update - July 2023

on 20 July

Therapeutic & Natural Health Products update

Kia Ora

Welcome to our latest newsletter which provides an update on the Therapeutic Products Bill.

The Bill passed the Committee of the Whole House and third reading stages in Parliament this week. These are significant milestones. Manatū Hauora | Ministry of Health acknowledges the feedback received from stakeholders during the parliamentary process that has informed the development of the Bill.

During the substantive debate in the Committee of the Whole House stage, the Minister of Health, the Hon Dr Ayesha Verrall, moved a supplementary order paper to amend the Bill to:

  • create an exemption mechanism for certain small-scale natural health product (NHP) manufacturers
  • remove many of the obligations that might apply to rongoā practitioners, services and activities
  • strengthen provisions relating to advertising regulations, providing the government more flexibility to regulate Direct-to-Consumer advertising appropriately
  • make minor and technical amendments to the Bill, including to ensure its consistency with New Zealand’s international obligations in relation to innovative medicines.

As Parliament has now passed the Bill, it will go to the Governor-General, Her Excellency the Rt Hon Dame Cindy Kiro, for her signature. At this point, the Bill will receive Royal assent and become an Act.

Even though the Bill will shortly be signed into law, most of its provisions will not come into force until much later. Section 2 of the Act provides that all of the provisions must commence by 1 September 2026. Until this happens, the existing Medicines Act 1981 (and Medicines Regulations) and Dietary Supplementary Regulations 1985 remain in force. Importantly, the transitional periods for current activities and existing products will only start once the Act commences.

By 1 September 2026 all the necessary secondary legislation will need to be in place and a new Regulator established. It’s a big task and we look forward to working with you to develop how the new regime will operate.

The team at Manatū Hauora has started planning for these next steps and will publish further details on the timing for engagement and consultation in the coming months.

Additional information on the Bill can be found on the updated Ministry’s website.

If you want to get in touch with the team, you can email us at: therapeuticproducts@health.govt.nz

Ngā mihi
Therapeutics Policy Team

Ministry of Health - Therapeutic Products

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