Notice Type
Departmental
Notice Title

Notice of Reassessment of Registered Trade Name Products (Notice No. MPI 988)

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

A000593

Mamyzin

Penethamate Hydriodide,

A005098

STOMORGYL 10

Metronidazole, Spiramycin,

A006397

STOMORGYL 2

Metronidazole, Spiramycin,

A006817

STOMORGYL 20

Metronidazole, Spiramycin,

A006867

BIVATOP 200

Oxytetracycline Dihydrate,

A010008

Cefamaster Dry Cow

Cephalonium,

A010727

Romagel VS

Cephalonium,

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:

Boehringer Ingelheim Animal Health New Zealand Limited, PO Box 76211, Manukau, Auckland.

Dated at Wellington this 8th day of April 2019.

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