NEW ZEALAND GAZETTE, No. 48

15 MAY 2014

Reason for Reassessment:

The policy surrounding the use of ionophore-based products in cattle for the purposes of growth promotion has been changed in the European Union (EU). As a result, MPI-approved label claims including those associated with growth promotion now require reassessment. In addition, there have also been changes to the EU Maximum Residue Limits (MRLs) set for the use of ionophore-based products in cattle. These MRL changes require a review of the currently approved withholding periods for ionophore-based products to ensure the use of these products will still comply with EU requirements for food exported to their market. This reassessment will only apply to those products used in cattle; products used exclusively in poultry and/or pigs have been excluded.

MPI considers the changes in the EU policy significant new information on a matter related to the use of the veterinary medicines containing ionophores for use in cattle (section 29(1)(a) of the Agricultural Compounds and Veterinary Medicines Act 1997).

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:

(a) must state in full the reasons for making the submission; and

(b) may state any decision sought on that application; and

(c) 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:

(a) where submissions on this application are to be sent; and

(b) where requests for copies of the public information relating to the application can be sent; and

(c) where public information relating to the application can be viewed; and

(d) the director-general’s address for service:

ACVM Group, Ministry for Primary Industries, Pastoral House, 25 The Terrace, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.

The applicant’s address for service is:

Merial New Zealand Limited, Level 3, Merial Building, 2 Osterley Way, Manukau, Auckland 2104. Postal Address: PO Box 76211, Manukau City, Auckland 2241.

Dated at Wellington this 12th day of May 2014.

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

Notice of Application to Register a Trade Name Product (Notice No. MPI 347)

Maree Zinzley, Manager (Approvals Operations) 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 ("the Act"), that the following application has been made to register a trade name product under section 9(1) of the Act:

Trade Name: Elanco Ovugel (triptorelin acetate) Gel for Intravaginal Use in Sows

Reference: A011084

Active Ingredient and Concentration:

100 mcg/mL triptorelin (as triptorelin acetate)

Formulation Type: Aerosol

General Use Claims:

For the synchronisation of time of insemination in weaned sows to facilitate a single-fixed-time artificial insemination.

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:

(a) must state in full the reasons for making the submission; and

(b) may state any decision sought on that application; and

(c) 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:

(a) where submissions on this application are to be sent; and

(b) where requests for copies of the public information relating to the application can be sent; and

(c) where public information relating to the application can be viewed; and

(d) the director-general’s address for service:

ACVM Group, Ministry for Primary Industries, Pastoral House, 25 The Terrace, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.

The applicant’s address for service is:

Elanco Animal Health, Level 1, 123 Ormiston Road, Flat Bush, Auckland 2016. Postal Address: PO Box 259354, Botany, Auckland 2163.

Dated at Wellington this 13th day of May 2014.

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

Biosecurity Act 1993

Approval of Kiwifruit Vine Health Incorporated and The KVH Foundation Incorporated as the Organisations Jointly Representing the Kiwifruit Sector for the Purposes of Part 5A of the Biosecurity Act 1993 (Notice No. MPI 344)

Pursuant to section 100ZA(2) of the Biosecurity Act 1993, the Minister for Primary Industries gives notice that he is satisfied that Kiwifruit Vine Health Incorporated and The KVH Foundation Incorporated together meet the criteria in subsections (3), (4), (6) and (9), and Kiwifruit Vine Health Incorporated and The KVH Foundation