Medical Products and Natural Health Products update - December 2024

on 20 December

 
Medical products and natural health products update
 

Kia ora

Welcome to the final update from the Ministry of Health’s | Manatū Hauora Therapeutics team for 2024.

 

Therapeutic Products Act Repeal Bill (‘Repeal Bill’)

As you may be aware, last week Parliament debated and passed the Therapeutic Products Act Repeal Bill. The Bill was signed into law by the Governor-General on 17 December and, as a result, the Therapeutic Products Act 2023 has been officially repealed.

A media release on the repeal of the Therapeutic Products Act can be found on the official Beehive website.

 

Repeal Bill implements a ‘lift-and-shift’ of the Dietary Supplements Regulations 1985

Last week Parliament agreed to amend the Repeal Bill to ‘lift-and-shift’ the Dietary Supplements Regulations 1985 (the Regulations). The effect of the amendment is to deem that the Regulations are made under the Food Act 2014, instead of the repealed Food Act 1981.

The amendment also included two changes to the Regulations themselves:

  • Inserting a clause that provides that the adopted joint food standards do not apply to dietary supplements. Despite this, changes can be made in the future to the Regulations to adopt joint food standards where necessary.
     
  • Revoking Part 3 (Offences and penalty) of the Regulations. This means that the offences, penalties and defences under the Food Act 2014 apply to dietary supplements in the same way as for other “food” regulated under the Act.

As a practical consequence of the amendment, the Regulations will no longer expire on 1 March 2026 and will, instead, continue in force until amended or revoked.

The ‘lift-and-shift’ means that all the administrative powers under the Food Act 2014 apply to dietary supplements, including the exemption powers for exported products. For example, exporters will be able to apply for exemptions from New Zealand labelling and composition requirements to enable them to better compete in international markets.

The ‘lift-and-shift’ is the first in a series of regulatory changes to facilitate the export of dietary supplements. The Ministry for Primary Industries is leading work on interim improvements to the Regulations, with more announcements expected in 2025.

A media release on the ‘lift-and-shift’ of the Regulations can be found on the Beehive website.

Webinar for stakeholders on the new Medical Products Bill

On 7 November, the Ministry of Health presented a public webinar on the planned Medical Products Bill. We were thrilled that so many of you joined us (nearly 500 people were online at one point).

A recording of the webinar, a questions and answers document and the PowerPoint slides can be found on the Ministry's site.

Contact us and Meri Kirihimete

We encourage you to keep an eye on the Ministry’s medical products and natural health product regulation webpage, which will be regularly updated with the latest information. Documents relating to the Medical Products Bill and the Therapeutic Products Act and its repeal can be found on the Ministry's website. If you would like more information or to contact the team, please contact us at therapeuticproducts@health.govt.nz.

Finally, thank you for your engagement with our work throughout 2024. From the team, we wish you a merry Christmas and a happy summer break. See you again in 2025!

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