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 application has been made to register a trade name product under section 9(1) of the Act:

Trade Name: Forceris Injection

Reference: A11632

Concentrations and Active Ingredients:

20 mg/mL Toltrazuril and 133.4mg Iron (as Gleptoferron 20% Fe)[100, 250, 500] mL

Formulation Type: Bolus

General Use Claims:

In piglets:

– For the reduction in oocyst excretion and the prevention of clinical signs of coccidiosis in farms with a confirmed history of coccidiosis caused by Cystoisospora suis.

– For the prevention of iron deficiency anaemia. Forceris is effective in one dose because it attacks all stages of the parasite in the animal. It controls coccidiosis caused by Cytoisospora suis infection of young piglets. Cytoisospora suis infection is a major cause of diarrhoea, dehydration, loss of appetite, poor growth and occasional mortality in piglets between birth and 3–4 weeks of age.

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, Pastoral House, 25 The Terrace, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.

The applicant’s address for service is:

Ceva Animal Health (NZ) Limited, C/-Bell Gully, Vero Centre, Level 22, 48 Shortland Street, Auckland 1010. Postal Address: Ceva Animal Health Pty. Ltd., PO Box 147, Glenorie, New South Wales 2157, Australia.

Dated at Wellington this 28th day of September 2018.

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