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 (“Act”) that the following variation application has been made to a registered trade name product under section 9(2) of the Act:

Trade Name: Readyserve Injection

Reference: A011440-02

Active Ingredient and Concentration:

Altrenogest 50mg/mL

Formulation Type: Oily solution

Current Claims:

For the suppression of oestrus in normally cycling mares.

Proposed New Claims (changes in bold):

For the suppression of oestrus in normally cycling mares. For the maintenance of pregnancy in habitually aborting mares at risk of early embryonic death or abortion where progesterone deficiency is thought to be the underlying cause.

Administer every five days from the 5th day after ovulation in the mated or inseminated mare until day 120 of gestation.

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.

The applicant’s address for service is:

Ceva Animal Health (NZ) Limited, Level 26, PWC Tower, 188 Quay Street, Auckland. Postal Address: PO Box 90098, Victoria Street West, Auckland 1142.

Dated at Wellington this 8th day of May 2020.

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