Maree Zinzley, Manager Approvals, 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: BIOCAN NOVEL DHPPi

Reference: A012023

Active Ingredients and Concentrations:

Canine Distemper virus, strain CDV Bio 11/A ≥10^3.1 TCID₅₀

Canine Adenovirus Type 2, strain CAV-2 Bio 13 ≥10^3.6 TCID₅₀

Canine Parvovirus Type 2b, strain CPV-2b Bio 12/B ≥10^4.3 TCID₅₀

Canine Parainfluenza Type 2 virus, strain CPiV-2 Bio 15 ≥10^3.1 TCID₅₀

*TCID₅₀ = tissue culture infectious dose 50%

Solvent: water for injection

Formulation Type: Lyophilisate and solvent for suspension

General Use Claim:

For vaccination of healthy dogs, as an aid in preventing disease caused by canine distemper virus, canine adenovirus type 1, canine adenovirus type 2, canine parvovirus and canine parainfluenza virus.

For the active immunisation of dogs from 6 weeks of age;

• to prevent mortality and clinical signs caused by canine distemper virus (CDV)
• to prevent mortality and clinical signs caused by canine adenovirus type 1 (CAV Type 1)
• to prevent clinical signs and reduce viral excretion caused by canine adenovirus type 2 (CAV Type 2)
• to prevent clinical signs, leukopenia and viral excretion caused by canine parvovirus (CPV)
• to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus (CPiV)

Onset of immunity:

• 3 weeks after the first vaccination for CDV, CAV, CPV
• 3 weeks after completion of the primary course for CPiV

Duration of immunity:

At least three years following the primary vaccination course for CDV, CAV and CPV. At least one year following the primary vaccination course for CPiV.

To be administered by subcutaneous injection.

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. Email: acvm.consultation@mpi.govt.nz.

The applicant’s address for service is:

AgriHealth NZ Limited, 89 Grafton Road, Auckland 1010.

Dated at Wellington this 4th day of April 2023.

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