Notice Type
Departmental
Notice Title

Notice of Reassessment of Registered Trade Name Products (Notice No. MPI 1452)

Publication Date
18 Mar 2022

Tags

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

Notice Number

2022-go989
Title
View PDF
File Type and Size
PDF (33 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 determine if the current residue specific conditions and label statements applied to the registrations of altrenogest injections are sufficient to mitigate risks to domestic food standards and trade.

The trade name products to be reassessed are:

Registration Number

Trade Name

Active Ingredient(s) and Concentration(s)

Formulation type

Current Claims

Registrant & Registrant Address

A011475

Ovu-Mate Injection for Horses

Altrenogest 50mg/mL

Non-aqueous Solution

For the suppression of oestrus in normally cycling mares

Randlab Australia Pty Ltd
7/85 Alfred Road
Chipping Norton
New South Wales 2170
Australia

A011561

BioRelease Altreno Injection

Altrenogest 150mg/mL

Non-aqueous Solution

A prolonged acting progestin injection for female horses

Dechra Veterinary Products NZ Limited
2 Cal Close
Somersby
New South Wales 2250
Australia


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.

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 17th day of March 2022.

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