Notice of Application to Vary the Conditions of a Registered Trade Name Product (Notice No. MPI 1025)
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
Reference: A11163-05
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:
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:
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).