Notice Title

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:

Purpose of reassessment

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:

  1. must state in full the reasons for making the submission; and
  2. may state any decision sought on that application; and
  3. must be received by the director-general no later than 30 working days after the date of notification in the New Zealand Gazette.

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:

  1. where submissions on this application are to be sent; and
  2. where requests for copies of the public information relating to the application can be sent; and
  3. where public information relating to the application can be viewed; and
  4. the director-general’s address for service:

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
PO Box 76369
Manukau
Auckland 2241

Alleva Animal Health Limited
PO Box 34032
Birkenhead
Auckland 0746

BioCell Corporation Limited
PO Box 23610 Hunters Corner
Manukau
Auckland 2155


Dated at Wellington this 20th day of November 2024.

SHALEEN NARAYAN, Manager Approvals Operations, Ministry for Primary Industries (acting under delegated authority).