Notice Type
Departmental
Notice Title

Notice of Reassessment of Registered Trade Name Products (Notice No. MPI 1172)

Publication Date
28 May 2020

Tags

Agricultural Compounds and Veterinary Medicines Act Reassessment of registered trade name products Primary Industries

Notice Number

2020-go2266
Title
View PDF
File Type and Size
PDF (31 KB)

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 products under section 29 of the Act.

The trade name products to be reassessed are:

Registration Number Trade Name Active Ingredients and Presentation
A008116 Cobactan LC 75mg cefquinome (as sulphate) per syringe in an intramammary infusion
A008163 Cobactan 2.5% Injection 25mg/mL cefquinome (as sulphate) in an oily suspension for injection

Further information about the trade name products listed above, including their approved uses and target species, can be found on the ACVM Register. The register can be found at https://eatsafe.nzfsa.govt.nz/web/public/acvm-register.

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

Each submission must state the trade name product(s) the submission pertains to.

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.

If you wish to provide a submission, please email your submission to ACVM.consultation@mpi.govt.nz. MPI encourages respondents to forward comments by email.

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 Programmes and Appraisals, New Zealand Food Safety, Ministry for Primary Industries, PO Box 2526, Wellington 6140.

The registrant/applicant’s address for service is:

Schering-Plough Animal Health Ltd, 33 Whakatiki Street, Upper Hutt 5018. Postal Address: Private Bag 908, Upper Hutt 5140.

Dated at Wellington this 27th day of May 2020.

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