Neomycin chemical review

In progress

Click on the tabs for more information about the status of each phase in the review process. For more information about how each phase is conducted, please read about the reconsideration process.

 

Work plan

Work plan

Click on the tabs for more information about the status of each phase in the review process. For more information about how each phase is conducted, please read about the reconsideration process.

Chemicals

  • Neomycin

Review period

Timeframe calculation pursuant to Regulation 85 of the Agricultural and Veterinary Chemicals Code Regulations 1995
A + B + 2E + 3C + J + D + X = 32 months

A = 0 months
B = 13 months (Residues – level 1)
C = 2 months (Finalisation – type 2)
D = 4 months
E = 3 months (Efficacy – level 3)
J = 3 months (consultation with jurisdictional coordinator)
X = 0 months (in any other case)
1. Nomination

1. Nomination

Phase status

Completed

Neomycin active constituents, chemical products and labels were nominated for review in 2002 because of concerns that the use of oral, intramammary and injectable preparations of neomycin, in accordance with the registered use pattern, could exceed the Australian maximum residue limit (MRL).

2. Prioritisation

2. Prioritisation

Phase status

Completed
3. Scoping and work plan

3. Scoping and work plan

Phase status

Completed

The scope of the review includes reconsideration of certain neomycin product registrations and labels through assessments related to residues, trade, and animal safety.

4. Notice of reconsideration

4. Notice of reconsideration

Phase status

Completed

The s 32 notice of reconsideration for chemical products and labels for neomycin was published in the Gazette on 6 February 2007.

The s 32 notice of reconsideration was given to holders and chemical coordinators of the states and territories upon commencement of the review on 31 January 2007.

Additional s 32 notices were sent to holders on 1 July 2015 to include all approved actives and registered products in the review.

5. Assessment

5. Assessment

Phase status

In Progress

In January 2017 the APVMA published the target animal safety risk assessment for neomycin.

When the residues and trade component risk assessment has been completed, the proposed regulatory decisions will be drafted.

6. Proposed regulatory decision

6. Proposed regulatory decision

Phase status

Forecasted

Publication of the proposed regulatory decision is expected in March 2024.

7. Consultation

7. Consultation

Phase status

Forecasted

The legislated timeframe for consultation following publication of the proposed regulatory decision is 3 months.

8. Final regulatory decision

8. Final regulatory decision

Phase status

Forecasted

Following the close of the public consultation period on the proposed regulatory decision and consideration of submissions received, the final regulatory decision will be published.

Publication of the final regulatory decision is expected in August 2024.

9. Implementation

9. Implementation

Phase status

Forecasted

The implementation period will begin on the date the final regulatory decision is made.

Publication archive
Was this page helpful?

Your feedback will be submitted to the APVMA anonymously. If you require a response, please contact us.

CAPTCHA