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: Bovilis MH + IBR

Reference: A011518-01

Active Ingredients and Concentrations:

Inactivated Mannheimia haemolytica isolate Leucotoxin producing strain
Inactivated Mannheimia haemolytica isolate
Inactivated Infectious Bovine Rhinotracheitis (IBR) strain

Formulation Type: Emulsion

General Use Claim:

Inactivated vaccine for the active immunisation of cattle against Bovine Respiratory Disease (BRD) caused by Mannheimia haemolytica and Infectious Bovine Rhinotracheitis Virus (Bovine Herpes Virus Type 1) and to reduce the intensity and duration of the clinical signs of infection and to reduce excretion of the field virus.

Target Species and Indications:

Cattle.

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:

Schering-Plough Animal Health Limited, 33 Whakatiki Street, Upper Hutt 5018. Postal Address: Private Bag 908, Upper Hutt 5140.

Dated at Wellington this 7th day of November 2017.

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