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(2) of the Act:
Trade Name: Dermcare Otoflush
Active Ingredients and Concentrations:
Poly(hexamethylene) biguanidine hydrochloride 2.0g/L
Disodium otitis externa 1.2g/L
Formulation Type: Aqueous Solution
Currently Approved Claim:
A neutral buffered ear flush solution to clean and reduce microbial numbers in ears of dogs and as a pre-treatment to improve the penetration of and increase bacterial susceptibility to antimicrobial preparations used to treat Canine Otitis Externa.
Proposed Addition to the Claim:
A neutral buffered pre-treatment ear flush solution to clean and reduce microbial numbers in ears of dogs and as a pre-treatment to improve the penetration of and increase bacterial susceptibility to antimicrobial preparations used to treat Canine Otitis Externa.
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:
Dermcare-Vet (NZ) Pty Ltd, Level 8, 53 Fort Street, Auckland. Postal Address: 7 Centenary Road, Slacks Creek, Queensland 4127, Australia.
Dated at Wellington this 11th day of June 2019.
MAREE ZINZLEY, Manager Approvals Operations, Ministry for Primary Industries (acting under delegated authority).