Gazette.govt.nzI, 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 product named below to ensure these details are consistent with the principles of prudent use for antibiotics and the prevention of antimicrobial resistance.
With the exception of Noroclav Tablets (A009010), these products are approved for use in food-producing species. The New Zealand maximum residue levels (MRLs) associated with the active ingredients, 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 |
|
A008295 |
Noroclav Injection |
Amoxicillin (as the trihydrate) 140mg and Clavulanic Acid (as potassium clavulanate) 35mg per mL in an oily suspension for administration by injection |
|
A009010 |
Noroclav Tablets |
Amoxicillin (as the trihydrate) and Clavulanic Acid (as potassium clavulanate) in a tablet for oral administration; the 50mg tablet size contains 40mg amoxicillin and 10mg clavulanic acid, while the 250mg tablet size contains 200mg amoxicillin and 50mg clavulanic acid |
| A009506 | Clavet LC | Amoxicillin (as the trihydrate) 200mg, Clavulanic Acid (as potassium clavulanate) 50mg, and Prednisolone 10mg as a suspension in a single dose injector for intramammary administration |
| A009737 | Noroclav Tablets 500mg | Amoxicillin (as the trihydrate) 400mg and Clavulanic Acid (as potassium clavulanate) 100mg in a tablet for oral administration |
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:
- 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.
The applicant’s address for service is:
Norbrook NZ Ltd, KPMG Centre, 18 Viaduct Harbour Avenue, Auckland 1010.
Dated at Wellington this 10th day of June 2020.
MAREE ZINZLEY, Manager Approvals Operations, Ministry for Primary Industries (acting under delegated authority).