Keeping ACVM users, importers, and manufacturers up to date ✉️🎄☀️
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Welcome to our December edition of the ACVM News and Views newsletter, our last newsletter for 2023.
In this month’s edition we’ll cover:
- Compliance update
- Inhibitor update
- Progress on the veterinary medicines queue
- Application processing times
- ACVM News and Views survey
- Christmas/New Year period
We would like to take this opportunity to wish you all the best for the holiday season. We look forward to continuing to keep you up to date on our work in 2024 and having a productive and rewarding year ahead.
The initial classification of non-compliance incidents received in November 2023 (Total 12):
The status of all incidents received in the year to date 2023 (Total 249):
Inhibitor update
ACVM has received and approved 40 applications for research approval but has yet to formally receive any applications for registration. The amendment to the ACVM Act, which is part of the Regulatory Systems (Primary Industries) Amendment Bill, was introduced into Parliament in June 2023 under the previous government but has yet to undergo its first reading. It is unknown when this amendment, which will bring products with an inhibitor claim under the scope of the ACVM Act, will have its first reading.
A regulatory interfaces project examined the interface between three agencies involved in inhibitor regulation: ACVM, the Greenhouse Gas Inventory, and the Environmental Protection Authority. The purpose of this project, which is set to finish this month, was to facilitate the streamlined processing of inhibitor products now and into the future. Several actions were identified across these three agencies to streamline the processing of inhibitor applications. These actions will be captured in an action plan by the project end date on 22 December 2023. Additionally, the inhibitors landing page on the MPI website will be refreshed with content providing guidance on approvals for research activities. This is expected to go live before Christmas. Please find updated inhibitor-based guidance here.
Progress on veterinary medicine queue
The team continues to make good progress with applications, with a steady stream flowing through to the delegate for final decision. The operations team are working hard to ensure a swift finalisation process to get the approval documents processed as soon as possible.
Since the pre-screen cut-off date, we have continued to see a steady stream of applications, almost entirely chemistry and manufacturing changes. With the trial still ongoing, these applications continue to be automatically accepted into the queue.
Agricultural chemicals and VTA application processing times
As of 14 December 2023, there are:
- 52 applications in appraisal
- 22 applications in the queue
- 0 with Plant Imports for biosecurity approval
In the queue there are:
- 11 new-product applications (6 A-type, 5 B-type)
- 7 new-use applications
- 1 manufacturing change
- 1 deviation
- 2 data assessment requests
Veterinary medicine application processing times
As of 14 December 2023, there are:
- 68 applications in appraisal
- 116 applications in the queue
- 3 with Animal Imports for biosecurity approval
In the queue there are:
- 7 new-product applications (4 A-type, 3 B-type)
- 8 new-use applications
- 97 manufacturing changes
- 2 deviations
- 0 data assessment requests
In the graph above, the queue is represented by the date applications were due to complete technical evaluation (i.e. day 25 of the 40 working day timeframe). Since mid-November, the number of chemistry and manufacturing changes due in September has almost halved as the team start to come off the peak of applications that were due between August and October.
ACVM News and Views survey
Please complete this short survey asking about your experience with receiving the ACVM News and Views Newsletter. We would love to hear your thoughts so we can ensure we are sending you the content you want to see.
The survey will close on Monday, 8 January 2024.
Christmas/New Year period
The Christmas non-working days under the ACVM Act are from 20 December 2023 to 15 January 2024. For the Christmas/New Year period, most Ministry for Primary Industries’ sites will be closed from 12pm on 22 December 2023, and will open again on 3 January 2024. Please note there will be minimal staff attendance on 22 December 2023 and from 3 to 5 January 2024.
Application submissions are now closed for 2023, but MPI will endeavour to continue to process ACVM applications prior to Christmas. Applications submitted after 1 December may not receive a pre-screen outcome until the week of 15 January 2024. Should the need arise for MPI to request further information for applications currently under assessment, your application is unlikely to be approved until after 15 January 2024.
Contact Us
ACVM Team, Assurance, New Zealand Food Safety / Haumaru Aotearoa
Pastoral House, 25 The Terrace
PO Box 2526
Wellington 6140
New Zealand
Email approvals@mpi.govt.nz
Website Agricultural compounds and veterinary medicines (ACVM) | Agriculture | NZ Government (mpi.govt.nz)
