NEW ZEALAND GAZETTE, No. 72 — 18 AUGUST 2016

Pursuant to Section 103 of the Crown Entities Act 2004

Under section 103 of the Crown Entities Act 2004, I, Jonathan Coleman, Minister of Health, direct the Pharmaceutical Management Agency (PHARMAC) to give effect to Government policy as specified below. This direction comes into effect on 1 September 2016.

The purpose of this direction is to ensure that PHARMAC contributes to New Zealand meeting its international obligations under the Trans-Pacific Partnership Agreement ("Agreement").

To this end, from the date that the Agreement enters into force for New Zealand, PHARMAC shall have regard to, in carrying out its functions, the need for New Zealand to comply with the obligations in Annex 26-A (Transparency and Procedural Fairness for Pharmaceutical Products and Medical Devices) to Chapter 26 (Transparency and Anti-Corruption) of the Agreement, including making adjustments to its practices and policies as necessary. I direct, in particular, that PHARMAC make available an internal review process pursuant to Article 3(e)(ii) of that Annex.

Dated this 8th day of August 2016.

HON JONATHAN COLEMAN, Minister of Health.

2016-go4752

Notice of Application to Register a Trade Name Product (Notice No. MPI 674)

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: Ilium Buccalgesic OTM

Reference: A011353

Active Ingredient and Concentration:

Meloxicam 10mg/mL

Formulation Type: Aqueous solution (a gel)

General Use Claim:

Oral Trans-Mucosal, Non-Steroidal, Anti-Inflammatory, Analgesic-Antipyretic. To assist in the alleviation and control of pain and its effects in cattle and sheep, including in routine surgical procedures such as dehorning of cattle, disbudding in calves, castration in cattle and sheep, and tail docking in sheep.

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:

a. must state in full the reasons for making the submission; and

b. may state any decision sought on that application; and

c. 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:

a. where submissions on this application are to be sent; and

b. where requests for copies of the public information relating to the application can be sent; and

c. where public information relating to the application can be viewed; and

d. 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:

Troy Laboratories NZ Pty. Limited, DFK Oswin Griffiths Carlton, Level 4, 52 Symonds Street, Auckland 1010. Postal Address: PO Box 385, Plumpton, New South Wales 2761, Australia.