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 variation application has been made to a registered trade name product under section 9(2) of the Act:

Trade Name: TRI-SOLFEN

Reference: A11409-04

Active Ingredients and Concentrations:

Lignocaine (as hydrochloride) 40.6g/L

Bupivacaine (as hydrochloride) 4.2g/L

Adrenaline (as acid tartrate) 24.8mg/L

Cetrimide 5.0g/L

Formulation Type: Aqueous solution

Current Claim:

TRI-SOLFEN is a local anaesthetic and antiseptic gel spray for pain relief on lambs following tail docking, on lambs and calves during and following castration.

Proposed New Claim (changes in bold):

TRI-SOLFEN is a local anaesthetic and antiseptic gel spray for pain relief on lambs following tail docking, on lambs and calves during and following castration and on calves after disbudding using hot iron cautery.

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:

Bayer New Zealand Ltd, 3 Argus Place, Hillcrest, Auckland 0627. Postal Address: PO Box 2825, Shortland Street, Auckland 1140.

Dated at Wellington this 16th day of November 2018.

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