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Regulatory Update #263
8 December 2017
Macrolide antibiotics—Proposed regulatory decisions report
On 30 November 2017 we published the macrolide antibiotics (kitasamycin, oleandomycin and tylosin) Proposed regulatory decisions report. The report is now open for consultation for a period of three months.
After consideration of all data and assessments, we have concluded that the use of macrolide antibiotics (kitasamycin, oleandomycin and tylocin)—according to their current instructions for use—does not meet the safety criteria listed in sections 5A of the Agvet Code for continued product registration and label approval. Our proposed regulatory decision suggests several actions. These are outlined in the report and available from our website.
The proposed regulatory decisions report is currently open for consultation. Please submit your submissions before close of business on Wednesday 28 February 2018.
Progress on APVMA permanent Armidale office
We have announced the appointment of engineering firm JNC Group for the design and fit-out of our permanent office in Armidale.
The fit-out includes signage, furniture and workstation selection, office and meeting room finishes.
This appointment brings us closer to establishing our permanent office by 2019. We are currently operating from two premises—one in Canberra, and an interim office in Armidale, co-located with the Department of Human Services.
Innovative technologies in drug toxicity testing
Read the latest Chief Scientist blog outlining emerging methodologies which are being explored by regulatory scientists all around the globe for potential use in predicting chemical toxicity.
The areas of toxicogenomics, in silico computational models and "organ-on-a-chip" methodologies are being closely monitored for their use in improving productivity of chemical screening and ethical testing processes. Staying abreast of emerging technologies is important to improving the accuracy and efficiency of our regulatory work.
Reminder—open for public consultation
We regularly seek input throughout chemical registration and review processes, and other operational and regulatory processes. We are currently seeking input on the following open consultations:
- Proposed approval of cocamidopropyl betaine in the product Crop Culture Nemo Aquatic Surfactant - 12 December 2017
- Proposed approval of the active cyclaniliprole in the product ISK Cyclaniliprole 50 SL Insecticide - 12 December 2017
- New active constituent Isofetamid - 12 December 2017
- Proposal to amend Schedule 20 of the revised Australia New Zealand Food Standards Code - 2 January 2017
- Macrolide antibiotics (kitasamycin, oleandomycin and tylosin) Proposed Regulatory Decisions - 28 February 2018
Contact us
- Phone our general enquiries number: +61 2 6210 4701
- Email: enquiries@apvma.gov.au
- Our mailing address is:
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
Kingston, Australian Capital Territory 2604
Australia
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