Notice Type
Departmental
Notice Title

Notice of Reassessment of Registered Trade Name Products (Notice No. MPI 1212)

Publication Date
15 Jun 2020

Tags

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

Notice Number

2020-go2549
Title
View PDF
File Type and Size
PDF (32 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:

Purpose of Reassessment

The purpose of the reassessment is to re-evaluate the approved label information, use patterns, and regulatory controls for the trade name products named below to ensure these details are consistent with the principles of prudent use for antibiotics and the prevention of antimicrobial resistance. As these products are approved for use in food-producing species, the New Zealand maximum residue levels (MRLs) associated with the active ingredient, and the products’ withholding periods, will also be re-evaluated during the reassessment.

The trade name products to be reassessed are:

Registration Number

Trade Name

Active Ingredients and Presentation

A007782

Moxylan 50mg Tablets Broad Spectrum Antibiotic

Amoxicillin (as the trihydrate) 50mg per tablet for oral administration

A007784

Moxylan 200mg Tablets Broad Spectrum Antibiotic

Amoxicillin (as the trihydrate) 200mg per tablet for oral administration
A007785 Moxylan Aqueous Drops Broad Spectrum Antibiotic Amoxicillin (as the trihydrate) 50mg per mL in an oral suspension, once reconstituted
A007786 Moxylan Ready-To-Use Injection Broad Spectrum Antibiotic Amoxicillin (as the trihydrate) 150mg per mL in an oily suspension for administration by injection


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.

The applicant’s address for service is:

Jurox New Zealand Limited, 8 Kordel Place, East Tamaki, Auckland 2013.

Dated at Wellington this 10th day of June 2020.

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