Notice Title

Notice of Application to Vary the Conditions of a Registered Trade Name Product (Notice No. MPI 70)

Notice is given under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”), of the following application to vary the conditions of a registered trade name product under section 9(2) of the Act:

Trade Name: BioBos RCC

Reference: A012072

Active Ingredients and Concentrations:

Inactivated Bovine Rotavirus, Bovine Coronavirus, and E.coli expressing F5 (K99) adhesin. Contains thiomersal (0.01% w/v).

Formulation Type: Aqueous suspension

Application Method / Administration Route:

Current administration route:

CATTLE: Administer 2mL, by intramuscular injection 12–3 weeks prior to calving. The recommended site is the anterior third of the neck. To minimise the potential for swelling at the site of injection, ensure vaccination is by deep intramuscular injection. Do not vaccinate at sites other than the recommended site.

Proposed administration route:

CATTLE: Administer 2mL, 12–3 weeks prior to calving, by deep intramuscular injection in the anterior third of the neck, or subcutaneous injection in the anterior third of the neck or the ischiorectal fossa. Do not vaccinate at sites other than the recommended sites.

Existing Use Claim:

Vaccine for cattle containing inactivated Bovine Rotavirus, Bovine Coronavirus, and E.coli expressing F5 (K99) adhesin.

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 this notice.

Each submission must state the trade name product(s) to which it relates. Under section 18 of the Act, a copy of every submission will be forwarded to the applicant.

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 Team, Ministry for Primary Industries, Charles Fergusson Building, 38–42 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140. Email: acvm.consultation@mpi.govt.nz.

MPI encourages submission by email.

The applicant’s address for service is:

AgriHealth NZ Limited, 89 Grafton Road, Grafton, Auckland 1010.

Dated at Wellington this 26th day of February 2025.

SHALEEN NARAYAN, Manager Approvals, Ministry for Primary Industries (acting under delegated authority).