Regulatory update #208

21 May 2015

Transitional arrangements for applications end on 30 June 2015

During May, the APVMA is writing to people with applications affected by the transitional arrangements to provide a list of unfinalised applications and to explain what will happen to these applications from 1 July 2015.

For applications which remain unfinalised on 1 July 2015, the APVMA will recalculate the timeframes and notify individual applicants in writing during July 2015.

Visit our website for more information on transitional arrangements.

Transitional arrangements for chemical reviews end on 30 June 2015

As part of the 1 July 2014 legislative reforms, chemical reviews (reconsiderations) commenced before 1 July 2014 and not concluded before 1 July 2015 will be transitioned according to the new legislation.

Visit our website for more information on transitional arrangements.

IT shut down 12–15 June 2015

There will be no access to APVMA online services from Friday 12 June at 5 pm until Monday 15 June at 7 am, as we will be moving our IT infrastructure. This affects all APVMA email and online services. Our website will remain operational.

Additional information and advice is available on our website.

Pre-application assistance re-design

Following the release of the pre-application assistance review, the APVMA has been working with industry and staff to come up with an improved approach to the way we provide assistance—from the simplest enquiry through to complex technical advice.

We will seek industry feedback on our progress at the information session in Sydney on 1 June 2015 and there will be opportunity for broader consultation soon after.

Risk assessment framework

We have commenced a project to develop a risk assessment framework for determining the appropriate regulatory effort to be used in assessing applications for product registration or active approval, aiming to identify and implement practical improvements and incorporate more efficient processes in the way the we manage applications.

We will be consulting with a wide range of stakeholders over the life of this project.Comments and feedback on the project are welcome at any time, including on reports we make available.

Any formal consultation undertaken for this project will be published on the APVMA consultation page.

Amended data guidelines

The following data guidelines were reviewed by the APVMA and changes made:

Spaces running out for Sydney Industry Information and Education Sessions—register now!

The APVMA is holding series of Industry Information and Education Sessions throughout 2015 and 2016.

The first session, on Monday 1 June 2015 in Sydney, is filling up fast and registrations are closing soon. Register now to secure your place in Sydney.

More information on the draft program and future sessions dates is available from the event page on our website.

Please note places are limited so register soon to secure your attendance.

Application tips

Reminder – information lists:

  • include all studies, arguments and pieces of information in your information list
  • every item of information listed should also have a file attached or be included on your CD/USB, if submitted separately
  • check that you have uploaded all relevant documents before you submit your application.

Reminder – overseas applicants:

  • every application submitted by an overseas holder for a new approval or registration should be accompanied by a completed nominated agent application (8M)
  • if you are an overseas holder and don't already have a nominated agent for your approvals or registration, you must appoint a nominated agent by completing a nominated agent application.

Reminder – e-labels:

  • all e-labels must be submitted through the E-label application on the APVMA portal
  • an e-label must be submitted for all new product applications and all variations where label changes are required.

Help and assistance

Telephone: +61 2 6210 4701

Reminder—open for public consultation

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