Contributed by: Craig Shrive, Victoria Piatov and Georgina Lomax-Sawyers
Published on: June 14, 2023
Parliament's Health Committee (Committee) has now reported back on the Therapeutic Products Bill (Bill), which would create a new regulatory regime for medicines, medical devices, artificial pharmaceutical ingredients and natural health products (NHPs).
The Committee was unable to reach agreement on whether to recommend that the Bill be passed. However, the Committee has recommended all amendments by majority, with the Committee's report also setting out the minority views from the Opposition and other MPs. The Committee has made a number of recommendations in relation to the Bill. These amendments include clarification of definitions of key terms and controlled activities, and some additional commentary on the market authorisation process.
Following the release of the Committee's report, the Government has also announced that it will introduce a Supplementary Order Paper to amend the Bill to remove many of its obligations on small-scale NHP producers and rongoā practitioners. The proposed changes include that small-scale NHP producers will not need to obtain a product authorisation or manufacturing licence from the new Regulator where their products are made and supplied in-person to customers in New Zealand. Further details on the exemptions for small-scale NHP producers will be set out in secondary legislation, to be made after the Bill passes.
The Government's intention was to pass the Bill this term, before the adjournment of the House of Representatives on 31 August 2023. However, it will need to act swiftly to achieve this, with only 24 sitting days left before it adjourns.
The Committee's report can be found here and our previous update on the Bill here. If you have any questions, including on the nature of the amendments that have been made to the Bill, please get in touch with one of our experts below.
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