Notice of Reassessment of Registered Trade Name Products (Notice No. MPI 49)
I, Shaleen Narayan, Manager Approvals Operations, of the Ministry for Primary Industries (MPI), acting under delegated authority from the Director-General of MPI, give notice, under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”), that a decision has been made to reassess the following trade name products under section 29 of the Act:
The purpose of the reassessment is to reconsider the risks to public health, trade in primary produce, animal welfare, and agricultural security associated with the use of injectable iodine supplementation products in cattle and sheep. This re-evaluation of the risk profile will then inform whether these products require continued classification as restricted veterinary medicines (RVMs) to manage those risks or are eligible for reclassification as unrestricted veterinary medicines.
The trade name products to be reassessed are:
Registration Number |
Trade Name |
Product Registrant |
A007866 |
Flexidine |
Elanco New Zealand |
A010699 |
Depodine Injection |
Alleva Animal Health Limited |
A011962 |
IodoBoost Iodised Oil for Injection |
BioCell Corporation Limited |
Further information about the trade name products listed above, including details of their approved uses and target species, can be found on the ACVM Register at https://eatsafe.nzfsa.govt.nz/web/public/acvm-register.
Any person may make a written submission to the director-general concerning this application.
Each submission must state the trade name product(s) to which the submission pertains.
Under sections 16 and 17 of the Act, a written submission:
Under section 18 of the Act, a copy of every submission will be forwarded to the applicant for the applicant’s information.
If you wish to provide a submission, please email your submission to ACVM.consultation@mpi.govt.nz. MPI encourages respondents to forward comments by email.
If you wish to forward a submission by post, the following address is:
ACVM Programmes and Appraisals, New Zealand Food Safety, Ministry for Primary Industries, PO Box 2526, Wellington 6140.
The registrants’ addresses for service are:
Elanco New Zealand |
Alleva Animal Health Limited |
BioCell Corporation Limited |
Dated at Wellington this 20th day of November 2024.
SHALEEN NARAYAN, Manager Approvals Operations, Ministry for Primary Industries (acting under delegated authority).