Regulatory update #187

16 May 2014

Pre-application assistance—new tool released

If you are seeking assistance with an application you intend to submit after 1 July 2014, you can now apply online through the APVMA portal.

Features of the new tool include:

  • the ability to upload supporting information
  • an online payment facility
  • a system generated reference number
  • your details are pre-filled if you are logged in to the portal.

Clarifying data requirements during transition

Uncertainty about data requirements as we move from the existing regulatory system, through the transitional period and into the post 1 July 2015 phase, has been raised as an issue.

To help clarify this area of uncertainty, an application which is already in the system on 1 July 2015 will be affected by changes to timelines and processes, but that will not change pre-existing data requirements.

In addition, while we expect applicants will follow the new regulatory guidance when planning for research, we will be flexible in considering applications which use data from trials commenced before the new regulatory guidelines are finalised. Ultimately, the APVMA must be satisfied about the safety, efficacy and quality in order to register a product or grant a permit.

Refer to frequently asked questions for additional information on transitional arrangements.

Training—places still available for the 12–13 June workshop

There are still places available for the second APVMA training workshop in Canberra on 12–13 June 2014. This free training will cover a variety of topics to help you get ready for changes that commence on 1 July 2014.

Test the new website and application and payment tools

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.

View details on the new tools, when they are being tested and how to sign up for user testing.

Draft legislative instruments—consultation closes soon

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 Wednesday 21 May 2014.

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.

  • Sinochem Neptune 17 EC Insecticide
  • Nufarm Trooper 242 Herbicide
  • Danisco Xylanase 40000 L For Pig And Poultry Feeds
  • Danisco Xylanase 8000 L Liquid For Wheat Based Pig Feeds
  • Equibute
  • Cadilac 75 WG
  • Comfortis (Spinosad) 140MG Chewable Tablets
  • Avizyme Type 1210 Liquid For Barley/Wheat-Based Poultry Feeds
  • Turzine-Pro Herbicide
  • Hostazym X 6000 Microgranulate
  • Hostazym X 6000 Liquid
  • Hostazym X 15000 Liquid
  • Hostazym X 30000 Microgranulate

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

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