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
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.
Neomycin 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
Completed
1. Nomination
Phase status: Completed
Oral, intramammary and injectable neomycin chemical products and associated label approvals 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
Completed
2. Prioritisation
Phase status: Completed
3. Scoping and work plan
Completed
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
Completed
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 and 13 September 2023 to include all registered products and approved labels in the review.
Section 33 notices were sent to holders on 8 January 2024 to request product-specific chemistry information.
5. Assessment
Completed
5. Assessment
Phase status: Completed
In January 2017 the APVMA published the target animal safety risk assessment for neomycin.
The APVMA published the draft Review Technical Report in February 2024.
6. Proposed regulatory decision
Completed
6. Proposed regulatory decision
Phase status: Completed
The APVMA published the proposed regulatory decision (PRD) for the neomycin reconsideration in an APVMA Special Gazette on 27 February 2024.
7. Consultation
Completed
7. Consultation
Phase status: Completed
The legislated timeframe for consultation following publication of the proposed regulatory decision is 3 months.
A public consultation (from 27 February 2024 through to 26 May 2024) was held for the proposed regulatory decision.
8. Final regulatory decision
Forecasted
8. Final regulatory decision
Phase status: Forecasted
The APVMA are currently considering the submissions received in response to the neomycin public consultation prior to making a final regulatory decision.
Publication of the final regulatory decision is expected in February 2025.
9. Implementation
Forecasted
9. Implementation
Phase status: Forecasted
The implementation period will begin on the date the final regulatory decision is made.
Publication Archive
| Type | Title | Publication date |
|---|---|---|
| Gazette | Neomycin Proposed Regulatory Decision | 27 February 2024 |
| Report | Draft Neomycin Review Technical Report | 27 February 2024 |
| 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 |