Debbie Morris, Director Branch Planning, Systems and Support, 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: TeatSeal

Reference: A7294-27

Active Ingredient and Concentration:

2.6g Bismuth subnitrate in an oily base/4g syringe

Formulation Type: Ointment

Current Claim:

Teatseal is indicated for the prevention of mastitis during the non-lactating (dry) period:

• In lactating heifers (first calvers) and cows with somatic cell counts (SCC) of less than 120,000 and 150,000 respectively.
• In cows and heifers with a higher SCC immediately following treatment with ORBENIN® Enduro (A6036) or ORBENIN® Dry Cow (A0888). Refer also to the labels for these products.

Proposed New Claim (changes in bold):

Teatseal is indicated for the prevention of mastitis during the non-lactating (dry) period:

• In lactating heifers (first calvers) and cows with somatic cell counts (SCC) of less than 120,000 and 150,000 respectively.
• In cows and heifers with a higher SCC immediately following treatment with ORBENIN® Enduro (A6036) or ORBENIN® Dry Cow (A0888). Refer also to the labels for these products.

Teatseal is retained for at least 20 weeks.

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

Zoetis New Zealand Limited, Level 5, 8 Mahuhu Crescent, Auckland Central, Auckland 1010. Postal Address: PO Box 2094, Shortland Street, Auckland 1140.

Dated at Wellington this 30th day of May 2017.

DEBBIE MORRIS, Director Branch Planning, Systems and Support, Ministry for Primary Industries (acting under delegated authority).