Notice Type
Departmental
Notice Title

Notice of Application to Vary the Conditions of a Registered Trade Name Product (Notice No. MPI 1665)

Maree Zinzley, Manager Approvals, 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: ProZinc Insulin Injection for Cats

Reference: A011421

Active Ingredient and Concentration:

40 IU human insulin

Formulation Type: Aqueous Solution

Current Claims:

For the treatment of diabetes mellitus in cats to achieve reduction of hyperglycaemia and improvement of associated clinical signs.

Proposed New Claim (changes in bold):

For the treatment of diabetes mellitus in cats and dogs to achieve reduction of hyperglycaemia and improvement of associated clinical signs.

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, Charles Fergusson Building, 34–38 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140. Email: acvm.consultation@mpi.govt.nz.

The applicant’s address for service is:

Boehringer Ingelheim Animal Health New Zealand Limited, Level 3, 2 Osterley Way, Manukau, Auckland 2104. Postal Address: PO Box 76211, Manukau, Auckland 2241.

Dated at Wellington this 8th day of June 2023.

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