Regulatory update #186

9 May 2014

Getting ready for 1 July 2014

Training—second training workshop announced

A second APVMA training workshop is scheduled to help people get ready for changes that commence 1 July 2014. This two-day event will take place in Canberra on 12–13 June 2014 and registrations are now open.

This free training will cover a variety of topics and has been designed around the feedback you provided.

View more information on training and getting ready for 1 July 2014.

Get involved in user testing

On 1 July 2014 we will be launching a new website. New application and payment tools—housed within a portal, are being progressively rolled out in the interim, with an updated payments system already launched. These new systems will make it easier for people to do business with us. We are currently undertaking user testing on the website and some of the tools and are seeking volunteers to get involved.

Testing and release days:

  • 2 May 2014: user acceptance testing (UAT) of decision tree tool commenced
  • 9 May 2014: UAT of the application aid
  • 12 May 2014: production release of registration self-assessment tool – Ag
  • 12 May 2014: UAT of the pre-application assistance tool
  • 19 May 2014: production release of electronic label particulars lodgement (e-Label).

Systems already updated and available include:

Draft legislative instruments available for consultation

The APVMA has released a number of draft legislative instruments for public consultation. The draft legislative instruments will be in force from 1 July 2014. Consultation closes on 21 May 2014.

Applications tools—what to expect in the new portal

The portal home screen will show user-specific information on payments, applications and submissions lodged with the APVMA, as well as an 'at a glance' status overview—or 'dashboard'.

The portal will give users access to new tools as well as updating some existing systems.

Tools include:

  • Registration self-assessment
  • Electronic label particulars lodgement (eLabel)
  • Decision tree—what item to apply under
  • Application aid
  • Pre-application assistance
  • Online levies and fees (OLAF)—updated (available only to registered users)
  • Certificate of export—updated.

Go to the website for more information.

Amendments to the APVMA maximum residue limit (MRL) standard

The MRL Standard has been amended, with affect from 3 May 2014.

The APVMA approves maximum residue limits (MRLs) of agricultural and veterinary chemicals in agricultural produce, particularly produce entering the food chain.

Details of the amendment can be found in the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) Amendment Instrument 2014 (No. 5). The amendments will be incorporated into the compilation of the Agricultural and Veterinary Chemicals Code Instrument No. 4 (MRL Standard) 2012.

Tylosin products: prescription only from 1 July 2014

From 1 July 2014, tylosin products will only be available under veterinary prescription.

Previously, products containing low concentrations of tylosin were classified in Schedule S5 and could be sold in retail outlets without a veterinary prescription. These have been rescheduled to S4 (Prescription Animal Remedy) and require a veterinary prescription.

Tylosin is a macrolide antimicrobial agent approved by the APVMA for use in poultry, pigs and cattle.

The Scheduling Delegate’s decision and rationale are available from the website of the Therapeutic Goods Administration.

Tylosin will still be available as an injection, water-soluble antimicrobial preparation and as premix, when prescribed by a veterinary practitioner.

Veterinarians are expected to comply with the Australian Veterinary Association’s Code of practice for prescription and use of products which contain antimicrobial agents when prescribing antimicrobial agents.

Reminder—open for public consultation

The APVMA is currently seeking comment on:

Applications

Advice Summaries published since last issue are listed below. For a complete list and further information, please refer to the Advice Summaries content on our website.

  • Suprelorin
  • Scorpio Ornamental Fungicide
  • Apparent Alonzo 750 WG Herbicide
  • Eazi-Breed Cidr Cattle Device
  • Aptitude Herbicide
  • Imtrade Octopus 800 WG Fungicide
  • Termitreat T-100 Wood Preserving Agent
  • Mycofix Secure
  • Melpat Mildex WG Fungicide
  • Amistar 250 SC Fungicide
  • Nufarm Grunt 750WDG Herbicide
  • Spada Herbicide
  • Smart IPIC 700 WG Herbicide
  • Enviromax Azoxystrobin 250 SC Fungicide
  • Scholar Fungicide
  • Avizyme 1510 Liquid For Poultry Feed
  • Milbeknock Miticide
  • Spotlight Plus Herbicide
  • Spotlight Plus Herbicide
  • 4CYTE Canine With Epiitalis For Joint And Cartilage Matrix Support
  • Avizyme 1510 Liquid For Poultry Feed
  • Milbeknock Miticide
  • Comfortis (Spinosad) 270MG Chewable Tablets

Application Summaries are updated weekly. For a complete list, please refer to the Application Summaries content on our website.

To protect your privacy, please do not include contact information in your feedback. If you would like a response, please contact us.