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Notice Type
Departmental
Notice Title

Notice of Reassessment of Registered Trade Name Product (Notice No. MPI ACVM 76)

Publication Date
13 Mar 2025

Tags

Agricultural Compounds and Veterinary Medicines Act Reassessment of registered trade name products Primary Industries

Notice Number

2025-go1368
Title
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File Type and Size
PDF (25 KB)

Notice is given under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”), of a decision to reassess the following trade name product under section 29 of the Act:

Purpose of Reassessment

The purpose of the reassessment is to re-evaluate the approved label information, use patterns, and regulatory controls for the trade name product named below to ensure these details are consistent with the principles of prudent use for antibiotics and the prevention of antimicrobial resistance. As this product is approved for use in food-producing species, the New Zealand maximum residue levels (MRLs) associated with the active ingredient, and the product’s withholding periods, will also be re-evaluated during the reassessment.

The trade name product to be reassessed is:

Registration Number:

Trade Name:

Active ingredient(s) and its concentration(s):

Registrant & Registrant Address:

A0052704

Spectrazol Milking Cow

Cefuroxime sodium

Schering-Plough Animal Health Limited, 33 Whakatiki Street, Upper Hutt 5018


Further information about the trade name product listed above, including details of their approved uses and target species, can be found on the Agricultural Compounds and Veterinary Medicines Register at https://eatsafe.nzfsa.govt.nz/web/public/acvm-register.

Any person may make a written submission to the director-general concerning this reassessment.

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 this notice.

Each submission must state the trade name product(s) to which it relates. Under section 18 of the Act, a copy of every submission will be forwarded to the registrant.

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 Team, Ministry for Primary Industries, Charles Fergusson Building, 38–42 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140. Email: acvm.consultation@mpi.govt.nz.

MPI encourages submissions by email.

Dated at Wellington this 11th day of March 2025.

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