Shaleen Narayan, Acting 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: Amplimune

Reference: A011741-01

Active Ingredients and Concentrations:

Mycobacterium Cell Wall Fraction 0.25g/L. Contains 30 mcg/mL Gentamicin as a preservative.

Formulation Type: Aqueous suspension

General Use Claim:

Amplimune is a one-time immunotherapeutic injection aid in the treatment of K99 positive Escherichia coli scours in neonatal calves (1 to 5 days of age). 

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:

NovaVive Inc., 79 Howard Crescent, Belleville, Ontario K8N 4Z7, Canada. Postal Address: NovaVive Inc., c/o New Wayz Consulting Limited, PO Box 36496, Northcote Point, Auckland 0748.

Dated at Wellington this 19th day of August 2019.

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