Notice of Reassessment of Registered Trade Name Products (Notice No. MPI 1009)

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
A003144	VIBROSTREP	Dihydrostreptomycin Sulphate, Streptomycin Sulphate,
A004730	AMPHOPRIM INJECTION	Sulphamethazine, Trimethoprim,
A004807	AMPHOPRIM BOLUS	Sulphamethoxypyridazine, Trimethoprim,
A005108	CLOXAGEL 1000 DC	Cloxacillin Benzathine, Cloxacillin Sodium Monohydrate,
A005301	INTRACILLIN 300 Injection	Penicillin G Procaine,
A006115	AEROTET FORTE	Gentian Violet, Oxytetracycline Hydrochloride,
A006307	OXYFOAM FORTE	Oxytetracycline Hydrochloride,
A006308	INTRACILLIN LA	Penicillin G Benzathine, Penicillin G Procaine,
A006389	TETRAGUARD LA	Oxytetracycline Dihydrate,
A006863	FOUNDERGUARD	Virginiamycin,
A007186	BOVIPEN	Penicillin G Procaine,
A007187	OVIPEN	Penicillin G Benzathine, Penicillin G Procaine,
A007518	INTRACILLIN HIGH POTENCY 500	Penicillin G Procaine,
A007662	RILEXINE 200 LC	Cephalexin,
A007787	INTRACILLIN 1000 MILKING COW	Penicillin G Procaine,
A008037	Masticillin	Penicillin G Procaine,
A009159	Rilexine Palatable Tablets	Cephalexin Mono-Hydrate,
A009341	Mastiguard Milking Cow.	Oleandomycin, Oxytetracycline Hydrochloride,
A009713	Tyloguard	Tylosin,
A009978	Cefaguard	Ceftiofur Present As Ceftiofur Hydrochloride,
A010107	Quadrant DC	Cephalonium,
A010279	Nitroclox LA	Cloxacillin Sodium Monohydrate,
A010305	Easotic	Gentamycin Sulphate, Hydrocortisone Aceponate, Miconazole Nitrate,
A010361	METRI-CLEAN	Cephapirin Benzathine,
A010884	PenClox 1200	Cloxacillin Sodium Monohydrate, Penicillin G Procaine,

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:

must state in full the reasons for making the submission; and
may state any decision sought on that application; and
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:

where submissions on this application are to be sent; and
where requests for copies of the public information relating to the application can be sent; and
where public information relating to the application can be viewed; and
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:

Virbac New Zealand Ltd, PO Box 10305, Te Rapa, Hamilton 3241.

Dated at Wellington this 10th day of April 2019.

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

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Purpose of Reassessment

The Trade Name Products to be Reassessed are: