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(1) of the Act:

Trade Name: SILEO 0.1 mg/mL Oromucosal Gel for Dogs

Reference: A11456-01

Active Ingredient and Concentration:

Dexmedetomidine hydrochloride 0.1mg/mL

Formulation Type: Oromucosal Gel

General Use Claim:

For the alleviation of acute anxiety and fear associated with noise in dogs.

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, Pastoral House, 25 The Terrace, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.

The applicant’s address for service is:

Orion Corporation, Orionintie 1A, Espoo FI-02101, Finland. Postal Address: PO Box 65, Espoo FI-02101, Finland.

Dated at Wellington this 24th day of April 2018.

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