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 variation application has been made to a registered trade name product under section 9(2) of the Act:
Trade Name: CANIGEN DHA2PPI
Active Ingredients and Concentrations:
Each single dose vial contains (minimum titres in CCID 50):
|live, attenuated canine distemper virus||103|
|live, attenuated canine adenovirus type 2 (infectious hepatitis)||104|
|live, attenuated canine parvovirus||105|
|live, attenuated canine parainfluenza virus||105|
Formulation Type: Freeze dried powder for reconstitution
General Use Claim:
Current Claims: “…An annual booster is recommended”
Proposed New Claim:
A booster vaccination is recommended one year after primary vaccination. Canigen DHA2PPi protects against Canine Distemper, Canine Infectious Hepatitis and Canine parvovirus for at least 36 months after the booster vaccination. Revaccinate against Canine parainfluenza annually. Canigen DHA2PPi can be used for annual revaccination.
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:
- must state in full the reasons for making the submission;
- may state any decision sought on that application; and
- 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:
- where submissions on this application are to be sent;
- where requests for copies of the public information relating to the application can be sent;
- where public information relating to the application can be viewed; and
- 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:
Virbac New Zealand Limited, 26–30 Maui Street, Pekete, Hamilton 3200. Postal Address: PO Box 10305, Te Rapa, Hamilton 3241.
Dated at Wellington this Monday, the 15th day of July 2019.
SHALEEN NARAYAN, Acting Manager Approvals Operations, Ministry for Primary Industries (acting under delegated authority).