Gazette.govt.nzI, 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 |
|
A011561 |
BioRelease Altreno Injection |
Altrenogest 150mg/mL |
Non-aqueous Solution |
A prolonged acting progestin injection for female horses |
Dechra Veterinary Products NZ Limited |
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:
- must state in full the reasons for making the submission; and
- may state any decision sought on that application; and
- 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:
- where submissions on this application are to be sent; and
- where requests for copies of the public information relating to the application can be sent; and
- where public information relating to the application can be viewed; and
- 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).