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(2) 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: COGLAVAX

Reference: A007528

Active Ingredients:

Clostridium perfringens Types A, B, C and D; Clostridium novyi Type B; Clostridium septicum; Clostridium tetani; and Clostridium chauvoei.

Formulation Type: Aqueous suspension

Current Claim:

An adjuvanted vaccine for the protection of livestock against the following diseases: Pulpy Kidney (Clostridium pefringens Type D), Malignant Oedema (Clostridium septicum), Blackleg (Clostridium chauvoei), Black Disease (Clostridium novyi Type B) and Tetanus (Clostridium tetani).

Proposed New Claims:

A polyvalent inactivated vaccine for the prevention of Clostridial infections in cattle and sheep.

Coglavax is indicated for the active immunization of sheep and cattle against the enterotoxaemia diseases, gas gangrene diseases and neurotoxic diseases caused by Clostridium perfringens Types A, B, C and D; Clostridium novyi Type B; Clostridium septicum; Clostridium tetani; and Clostridium chauvoei.

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; and
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; and
2. where requests for copies of the public information relating to the application can be sent; and
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, Level 22, Vero Centre, 48 Shortland Street, Auckland 1010. Postal Address: PO Box 147, Glenorie, New South Wales 2157, Australia.

Dated at Wellington this 3rd day of October 2016.

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