Notice Type
Departmental
Notice Title

Notice of Reassessment of Registered Trade Name Products (Notice No. MPI 1454)

Publication Date
16 Mar 2022

Tags

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

Notice Number

2022-go962
Title
View PDF
File Type and Size
PDF (35 KB)

I, Maree Zinzley, Manager Approvals, 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.

Purpose of Reassessment

The purpose of the reassessment is to:

  1. determine if a restricted veterinary medicine status is required to ensure the safe and effective administration of omeprazole products in horses, or alternatively, if risks may be adequately mitigated with unrestricted access; and
  2. to review the residue controls across the product class to ensure they are aligned.

Active Ingredient: Omeprazole.

Formulation Type: Oral pastes and oral granules.

General Claim: For treatment and prevention of recurrence of gastric ulcers in horses.

Dosage Range: 1–4mg/kg once daily.

The trade name products to be reassessed are:

Registration Number Trade Name Registrant Registrant Address
A010085 Omoguard Paste for Horses Ceva Animal Health (NZ) Limited Level 26, PwC Tower, 188 Quay Street, Auckland
A010625 CaleGastro Dechra Veterinary Products NZ Limited 198A Kapiti Road, Paraparaumu
A010775 Gastropell Forte Oral Paste for Horses Randlab Australia Pty Limited NZ Agent – Randlab New Zealand Limited, 3/180 Montgomerie Road, Mangere, Auckland
A010165 Gastropell Daily
A010916 Ulcershield Paste for Horses
A009651 Gastrozol Daily Oral Paste For Horses Virbac New Zealand Limited 26–30 Maui Street, Pukete, Hamilton
A011781 Equestra Equine Omeprazole Equestra Pty Ltd NZ Agent – Troy Laboratories NZ Pty Limited, c/o William Buck (NZ) Limited, Level 4, Zurich House, 21 Queen Street, Auckland

Further information about the trade name products listed above, including details of their approved uses and target species, can be found on the ACVM Register 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) to which the submission pertains.

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.

If you wish to forward a submission by post, 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.

Dated at Wellington this 15th day of March 2022.

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