Notice Type
Departmental
Notice Title

Notice of Application to Register a Trade Name Product (Notice No. MPI 977)

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: Nobivac Oral Bb

Reference: A011653-01

Active Ingredient and Concentration:

Bordetella bronchiseptica, strain B-C2 (≥ 1 x 109 CFU per dose)

Formulation Type: Freeze-dried powder plus reconstituting diluent

General Use Claim:

Live oral vaccine to aid in protection against canine infectious tracheobronchitis (Canine Cough complex) caused by Bordetella bronchiseptica for at least 12 months following vaccination.

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:

Schering-Plough Animal Health Ltd, 33 Whakatiki Street, Upper Hutt 5018. Postal Address: Private Bag 908, Upper Hutt 5410.

Dated at Wellington this 11th day of March 2019.

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