Notice Type
Departmental
Notice Title

Notice of Reassessment of Registered Trade Name Products (Notice No. MPI 997)

Publication Date
15 Apr 2019

Tags

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

Notice Number

2019-go1679
Title
View PDF
File Type and Size
PDF (33 KB)

I, Maree Zinzley, 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 reassessment of the trade name products listed below are to establish whether a condition should be imposed on the registration of each of the trade name products listed below. Those trade name products are all antibiotics. The proposed condition would prohibit the advertising of the trade name product, being an antibiotic, to the end-users.

The Trade Name Products to be Reassessed are:

Reference

Trade Name

Active ingredients and concentrations

A003547

TRICIN

Neomycin Sulphate, Polymyxin, Zinc Bacitracin,

A007725

JURACLOX L.A. 600 DRY COW LONG ACTING INTRAMAMMARY SUSPENSION

Cloxacillin Benzathine,

A007782

MOXYLAN 50MG TABLETS BROAD SPECTRUM ANTIBIOTIC

Amoxicillin,

A007784

MOXYLAN 200MG TABLETS BROAD SPECTRUM ANTIBIOTIC

Amoxicillin,

A007785

MOXYLAN AQUEOUS DROPS BROAD SPECTRUM ANTIBIOTIC

Amoxicillin,

A007786

MOXYLAN READY-TO-USE INJECTION BROAD SPECTRUM ANTIBIOTIC

Amoxicillin,

A009853

Juroclav 50 Broad Spectrum Antibiotic Tablets

Amoxycillin Present As Amoxycillin Trihydrate, Clavulanic Acid Present As Potassium Clavulanate,

A009854

Juroclav 250 Broad Spectrum Antibiotic Tablets

Amoxycillin Present As Amoxycillin Trihydrate, Clavulanic Acid Present As Potassium Clavulanate,

A009855

Juroclav 500 Broad Spectrum Antibiotic Tablets

Amoxycillin Present As Amoxycillin Trihydrate, Clavulanic Acid Present As Potassium Clavulanate,

A009887

Maxalac L.C. Intramammary Antibiotic

Cefuroxime Sodium,

Further information about each of the trade name products listed above, including its intended use, can be found on the ACVM Register that is available on MPI’s website: https://eatsafe.nzfsa.govt.nz/web/public/acvm-register.

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

Each submission must state the trade name product(s) the submission pertains to.

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 registrant for the registrant’s information.

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 Group, Ministry for Primary Industries, Charles Fergusson Building, 34–38 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.

The registrant’s address for service is:

Jurox New Zealand Ltd, 85 Gardiner Street, Rutherford, New South Wales 2320, Australia.

Dated at Wellington this 8th day of April 2019.

MAREE ZINZLEY, Manager Approvals Operations, Ministry for Primary Industries (acting under delegated authority).