Regulatory update #199

25 September 2014

Requirements for consent to rely on confidential commercial information for reference products

The APVMA has received a number of requests to further explain the requirements for obtaining consent for confidential commercial information (CCI) for reference products.

Kareena Arthy, Chief Executive Officer, has issued a statement that provides more background to the requirement and outlines alternatives for applicants if they don’t have consent to use CCI material.

Online services—phase one dashboard launch

Applicants can now access a single view of all of their applications via the registration and permits section of our online services.

The dashboard allows easy oversight of details such as the status, relevant dates and product name and ID of all applications submitted by a company since 1 July 2014. Included is the ability to search applications by:

  • decision ID
  • application number
  • item number
  • item status
  • submitted by
  • product name
  • product ID.

Further functionality of the dashboard is in development.

Farewell to Executive Director, Veterinary Medicines

Further to the Regulatory Update #198 (19 Sep 2014) notice on the APVMA’s new organisational structure, Dr Allen Bryce has advised that he will be leaving the APVMA at the end of January 2015.
 
Allen leaves the APVMA after five busy and productive years in the role of Executive Director, Veterinary Medicines. He arrived in the agency at a time of great change and has guided the program through major reforms such as implementing new legislation, systems and processes. He been particularly successful in continuing to build strong relationships with industry through these changes.
 
Allen intends to use his knowledge of the industry and broader veterinary skills to contribute further to the community in retirement.
 
An acting Executive Director will be appointed to lead the Registration Management and Evaluation program from 1 October 2014 until the position is permanently filled.

4 weeks to go: 2014 Nanotechnology Regulation Symposium—register now!

The Nanotechnology Regulation Symposium in Canberra on 28 October 2014 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.

Led by Dr Norman Swan, speakers include:

  • Dr Phil Reeves (APVMA): setting the scene—benefits and potential risks
  • Dr Jan Herrmann (NMI), Prof Terry Turney (Monash University), Dr John Hughes (APVMA): nanometrology, physicochemical properties, manufacture
  • Prof Brian Priestly (Monash University), Prof Michael Roberts (University of Queesland and University of South Australia), Dr Andrew Batholomaeus (University of Canberra): human health considerations
  • Dr Rai Kookona (CSIRO), Dr Graeme Batley (CSIRO), Dr Glen Walker (Department of Environment): environmental considerations.

Providing a basis for discussion, the APVMA will publish a draft nanotechnology report in late September 2014.

Reminder—open for public consultation

Help and assistance

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

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.

  • CCD Amoxycillin Trihydrate For Poultry
  • Prascend 1MG Tablet For Horses
  • Exothor Insect Growth Regulator
  • Campbell Stanza WP Fungicide
  • Bumper 625 EC Fungicide
  • Culithor Granular Mosquito Growth Regulator
  • Onix Plant Growth Regulator
  • Tiamulabs Tiamulin Soluble Powder
  • Termidor Dust Termiticide
  • Lascar Insect Growth Regulator

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

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