Macrolide antibiotics (kitasamycin, oleandomycin and tylosin) Proposed Regulatory Decisions

The macrolide antibiotics Proposed Regulatory Decisions (PRD) report was published on 30 November 2017 for a three months consultation period.

After consideration of all data and assessments, the APVMA 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 registration and approval.

The APVMA proposes the following regulatory actions:

1. Vary label approvals of selected products to:

• delete product claims and associated use instructions for growth promotion and improved feed conversion efficiency (in pigs)
• add the following restraint statement relating to prudent use of antimicrobials:

‘Prior to prescribing [Name of Product] investigate the use of non-antibiotic options. If [Name of Product] is indicated and selected for use, prudent prescribing practices (appropriate dose, duration and frequency to minimise treatment failure while minimising the emergence of antimicrobial resistance) must be adhered to.

NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO THIS LABEL.’

2. affirm these product registrations once the necessary label variations have been made
3. cancel all previous product label approvals that are not consistent with the review outcomes and
4. cancel the registrations and associated label approvals of the product TRUBIN L-50 GROWTH PROMOTANT FOR PIGS (35806). The only use for this product is growth promotion which cannot be supported. 

Invitation for submissions

The Proposed Regulatory Decisions report is now available and submissions are invited from interested parties. The closing date for submissions is COB Wednesday 28 February 2018.

The public, industry and interested parties are invited to provide written submissions on the proposed decisions for the reconsideration. The APVMA will consider those comments when making the final decisions for the macrolide antibiotics review.

Preparing your comments for submission

When making your comments:

• clearly identify the issue and clearly state your point of view
• give reasons for your comments, supporting them, if possible, with relevant information and indicating the source of the information you have used
• suggest to the APVMA any alternative solution you may have for the issue.

Please structure your comments in point form, referring each point to the relevant section in the report.

All submissions to the APVMA will be acknowledged in writing via email or by post.

When making a submission please include:

• contact name
• company or group name (if relevant)
• postal address
• email address (if available)
• the date you made the submission.

Note that all submissions received are subject to the Freedom of Information Act 1982, the Privacy Act 1988 and the Agvet Codes. All personal and confidential commercial information (CCI) material contained in submissions will be treated confidentially. A full definition of ‘confidential commercial information’ is contained in the Agvet Code.

Submissions can be sent to:

Director, Chemical Review
Australian Pesticides and Veterinary Medicines Authority
PO Box 6182
KINGSTON ACT 2604
Telephone: +61 2 6210 4749 Fax: +61 2 6210 4776
Email: chemicalreview@apvma.gov.au
Website: www.apvma.gov.au