Maree Zinzley, Manager Approvals, of the Ministry for Primary Industries (MPI), acting under delegated authority from the Director-General of MPI, gives notice under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”) that the following application has been made to register a trade name product under section 9(1) of the Act:

Trade Name: Lepto 4-way

Reference: A012030-01

Active Ingredients and Concentrations:

Contains inactivated cultures of Leptospira borgpetersenii serovar Tarassovi and Leptospirainterrogans: serovars Hardjo, Copenhageni and Pomona

Formulation Type: Aqueous Solution

General Use Claim:

For the vaccination of cattle against Leptospirosis caused by L. borgpetersenii serovars Hardjo (Hardjobovis) and Tarassovi, L. interrogans serovars Copenhageni and Pomona, and cross-protection against Tarassovi-like (TAR-like) leptospirae. To prevent the shedding in urine of these serovars, and thus reduce the risk of human Leptospirosis infection.

The vaccine antigen Leptospira borgpetersenii serovar Tarassovi is novel to veterinary medicines in New Zealand, as is the claim for cross-protection against Tarassovi-like leptospirae.

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

Under sections 16 and 17 of the Act, a written submission:

1. must state in full the reasons for making the submission;
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.

The following address is:

1. where submissions on this application are to be sent;
2. where requests for copies of the public information relating to the application can be sent;
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. Email: acvm.consultation@mpi.govt.nz.

The applicant’s address for service is:

Virbac New Zealand Limited, 26–30 Maui Street, Pukete, Hamilton 3200. Postal Address: PO Box 10305, Te Rapa, Hamilton.

Dated at Wellington this 5th day of May 2023.

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