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 1995A + 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
CompletedNeomycin 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
CompletedThe 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
CompletedThe 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 ProgressIn 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
ForecastedPublication of the proposed regulatory decision is expected in March 2024.
7. Consultation
7. Consultation
Phase status
ForecastedThe legislated timeframe for consultation following publication of the proposed regulatory decision is 3 months.
8. Final regulatory decision
8. Final regulatory decision
Phase status
ForecastedFollowing 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
ForecastedThe implementation period will begin on the date the final regulatory decision is made.
Publication archive
Publication Archive
| Type | Title | Publication date |
|---|---|---|
| Report | Neomycin: Target animal safety risk assessment report | 23 January 2017 |
| Report | Neomycin review scope document | 6 February 2007 |
| Gazette | The reconsideration of registrations of products which contain neomycin and their associated approved labels | 6 February 2007 |