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: Albiotic

Reference: A7712-18

Active Ingredients and Concentrations:

LINCOMYCIN (as lincomycin hydrochloride) 330mg
NEOMYCIN (as neomycin sulphate) 100mg

Formulation Type: Aqueous solution

Current Label:

For the treatment of bovine mastitis caused by organisms sensitive to lincomycin and neomycin:

Administer one syringe (10ml) per infected quarter. Repeat treatment for up to three doses.

For twice daily milking: Treatment may be repeated at 12 hour intervals, up to a total of 3 doses, if necessary.

For once daily milking: Treatment may be repeated at 24 hour intervals, up to a total of 3 doses, if necessary.

Proposed New Label (changes in bold):

For the treatment of bovine mastitis caused by organisms sensitive to lincomycin and neomycin:

Administer one syringe (10mL) per infected quarter after each consecutive milking for 3 doses, or up to 6 doses for extended treatment.

For twice daily milking: Administer one syringe after each milking, twice daily.

For once daily milking: Administer one syringe after each milking, once daily.

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:

Agrihealth NZ Limited, Unit 1.2, 89 Grafton Road, Grafton, Auckland 1010.

Dated at Wellington this 24th day of January 2018.

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