Regulatory update #198

From 1 October 2014, the APVMA will operate with a new organisational structure

The new structure is designed to provide an industry-focused registration process which is underpinned by quality scientific assessment and risk management practices. Our aim is to improve lines of accountability, increase our flexibility, better support our stakeholders through the registration process and streamline the delivery of other APVMA functions.

Information that must be included in data lists

Applicants are reminded that they need to provide a list of all the information that makes up their application (the 'data list') or the application will be refused.

The data list must include all the documentation submitted with the application—as well as listing all studies, it must include other documentation that addresses safety, efficacy and trade criteria, such as safety data sheets, declaration of composition or letters of consent, that were not previously required in data lists.

Our online services include a section to upload information and complete the relevant entry to create a 'data list'. This section will be enhanced to provide applicants with more options for data type and applicants will be reminded, when uploading any information, to complete a data list entry.

Electronic payment of fees

Legislative changes from 1 July 2014 mean that fees must be paid by electronic means—credit card, BPay or EFT. Cheques or cash are not accepted.

From 3 October 2014, in line with new regulation 69A, cheque or cash payments will be rejected, ending a three month transitional period.

Fees may be paid online, using credit card. Additional fees for applications may be submitted by fax to +61 2 6210 4700, by using the application fee invoice. The functionality to pay these fees by BPay and EFT will be available in our online services in the upcoming months.

Speakers confirmed: 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

• Proposed approval of the new active constituent, H. contortus integral membrane glycoproteins, and registration of BARBERVAX Barber's Pole worm vaccine  – until 23 September 2014
• Proposal to Amend Standard 1.4.2 of the Australia New Zealand Food Standards Code  – until 23 September 2014
• Proposed approval of the new active constituent, flonicamid and registration of Mainman 500WG Insecticide  – until 7 October 2014

Help and assistance

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

Applications

Advice summaries: for a complete list and further information, please refer to the advice summaries content on our website.

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