Notice Type
Departmental
Notice Title

Notice of Reassessment of Registered Trade Name Product (Notice No. MPI 999)

I, Maree Zinzley, Manager Approvals Operations, of the Ministry for Primary Industries (MPI), acting under delegated authority from the Director-General of MPI, give notice, under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”), that a decision has been made to reassess the following trade name product under section 29 of the Act.

Purpose of Reassessment

The reassessment of the trade name product listed below is to establish whether a condition should be imposed on the registration of the trade name product listed below. The trade name product is an antibiotic. The proposed condition would prohibit the advertising of the trade name product, being an antibiotic, to the end-users.

The Trade Name Product to be Reassessed is:

Reference

Trade Name

Active ingredients and concentrations

A009570

Clavubactin

Amoxicillin, Clavulanic Acid,

Further information about the trade name product listed above, including its intended use, can be found on the ACVM Register that is available on MPI’s website: https://eatsafe.nzfsa.govt.nz/web/public/acvm-register.

Any person may make a written submission to the director-general concerning this reassessment.

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 registrant for the registrant’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, Charles Fergusson Building, 34–38 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140.

The registrant’s address for service is:

Le Vet Beheer B.V., Wilgenweg 7, 3421 TV Oudewater, Netherlands.

Dated at Wellington this 8th day of April 2019.

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