Regulatory update #197

11 September 2014

Applications without written consent for reference products

As part of the ongoing review and improvement of registration processes the APVMA has identified a number of applications where written consent to use the confidential commercial information for reference products was not provided.

Consent is required from owners to access confidential commercial information such as formulations or specifications, and written consent is a requirement under the Agvet Code.

The APVMA is writing to affected people about what they need to do to progress their application.

We will provide as much assistance as possible to applicants, including providing as much time as possible (within legislative constraints) for consent to be obtained.

View more information for affected applicants.

View more information on confidential commercial information and written consent.

Changes to authorised agents

Following some practical concerns raised by industry, we have reviewed our approach to the role of authorised agents to provide greater clarity between this role and that of a nominated agent.

What's changed?

  • Access is still granted and managed by the holder but is no longer automatically cancelled upon completion of the application.
  • It is no longer a requirement for an authorised agent to be linked to an application.
  • The authorised agent role extends beyond a single application, including the capacity to submit a new application or vary an existing product.

Role summary

An authorised agent:

  • can be a single person or an entity
  • can submit an application on behalf of the holder (including an application for a new product or a variation for an existing product)
  • has authorisation to transact on behalf or the applicant for the application in question
  • can save and access previously submitted applications, for which they hold the authority to access.

These changes are effective immediately.

We are updating our website to provide greater clarity on all security roles and people will soon be able to manage these roles and change details by logging in to our online services—more information on this online 'Access Manager' in the next Regulatory Update.

Online services update—coming soon

Online applications for items 21 and 22 will be available next week.

The applicants dashboard—a single view of all your applications—will be available next week.

Additional information on system fixes and planned enhancements is available on our website.

2014 Nanotechnology Regulation Symposium—registrations now open

The APVMA is hosting a Nanotechnology Regulation Symposium in Canberra on 28 October 2014 and registrations are now open.

The symposium will host a range of leading national guest speakers and experts on nanotechnology and its application to agricultural and veterinary medicines. It will provide industry and regulators with an opportunity to exchange ideas and information about the future regulation and registration of nanopesticides and veterinary nanomedicines.

The APVMA will publish a draft nanotechnology report in late September 2014 which will provide a basis for discussion at the symposium.

Help and assistance

Visit: www.apvma.gov.au
Telephone: +61 2 6210 4701
Email: enquiries@apvma.gov.au

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.

  • Loxicom Injection For Cattle And Pigs
  • Aminocyclopyrachlor
  • Weedbeater
  • Ultraforce Termite Foam Insecticide
  • Nufarm Nuprid 350SC Insecticide
  • International Biolux New Technology Trilux 33 Hard Antifouling For Aluminium
  • Imtrade Metal Gold 960 EC Herbicide
  • Macphersons Mavro 90 EC Selective Herbicide
  • HOV Vaporgard Moth Membrane
  • Ultraforce Cockroach Bait

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

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