Important news: 2006-07 annual charges

Last year the TGA announced a number of changes to invoicing arrangements for product annual charges. The key features of the changes included:

• alignment of the billing date for all products on the ARTG
• pre-processing cancellations and low turnover exemptions to avoid unnecessary invoicing and processing of credit notes
• providing companies with electronic invoices
• allowing companies to pay invoices by quarterly instalment
• implementing options for credit card and direct debit payment via the Internet (planned for introduction in July 2006).

2006-07 annual charges will be issued to companies on 1 September 2006 for all products entered on the ARTG as at 1 July 2006. To improve the effectiveness of the annual charges process, we ask companies to undertake the following steps.

• Complete a review of your company's product range prior to the end of the financial year and advise the TGA of any products you wish to cancel no later than 15 August 2006 - this will avoid unnecessary inclusions in your annual charges invoice.
• Assess whether your company is likely to have any low turnover products. Low Value Low Volume declarations should be submitted together with the applicable fee no later than 15 August 2006 to avoid products being listed in your annual charges invoices.
  
  Companies can submit low turnover declaration applications for 2006-07 prior to the end of the financial year based on the current year's estimate of sales. (The TGA may contact you later in the year to validate your estimate.)
• If you would like to receive your invoice electronically, simply complete a registration form and return it to the TGA Revenue Manager as soon as possible (fax 02 6232 8222).

Companies are also reminded that they continue to be liable for any annual charges outstanding against a product (including instalments). Transfers of products cannot be completed until outstanding amounts are settled in full.

Forms to authorise the cancellation of a product from the ARTG (sponsor-cancellation) and registration forms for electronic invoicing <http://www.tga.gov.au/docs/html/feesach.htm> are available on the TGA Internet site. Details for low turnover declarations and the applicable fees will be available shortly.

For further details, please contact the TGA Revenue Manager on 02 6232 8218.

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ANZTPA update

The Therapeutic Products Interim Ministerial Council announced in December 2005 that the title of the new trans-Tasman regulatory agency will be the Australia New Zealand Therapeutic Products Authority.

The joint regulatory scheme will be set out in a single set of 'Ministerial Council Rules' which will apply in both countries. It is expected that the first package of the draft Ministerial Council Rules for the new scheme will be released for consultation in the forthcoming months with consultation on the implementing Bills to commence in mid-2006.

The introduction of the legislation to the New Zealand parliamentary system and release as an exposure draft for industry consultation in Australia will signal the beginning of formal consultations with interested parties on the legislation. The joint regulatory scheme will commence after the passing of legislation in both countries.

In consideration of the need to allow for this extensive consultation program with industry on the legislation and rules for the new Authority and the completion of the parliamentary processes, the Interim Ministerial Council also confirmed that the commencement date for the new Authority would need to be deferred.

Mr Philip Davies has been appointed to the time-limited role of Transitional Director for the Joint Agency Establishment Group and supplements the resources of the existing management team as the two countries move under a single Authority.

More information on the Authority can be found on the ANZTPA Internet site <http://www.anztpa.org>.

Business plan ­ quarterly report

The Quarterly Report of the TGA Group of Regulators against the 2005-2006 Business Plan for the period 1 July - 30 September 2005 <http://www.tga.gov.au/about/tgagorbp0506.htm> is available on the TGA Internet site.

This report addresses both continuing responsibilities and major project initiatives for the financial year, including the development of the regulatory arrangements to apply following the commencement of the ANZTPA and the joint regulatory scheme for therapeutic products that the agency will administer.

NDPSC update

The National Drugs and Poisons Schedule Committee post-October 2005 and the pre-February 2006 meeting gazette notices <http://www.tga.gov.au/ndpsc/ndpscgan.htm> and the record of the reasons <http://www.tga.gov.au/ndpsc/records.htm> for the October 2005 meeting are available.

The NDPSC membership list <http://www.tga.gov.au/ndpsc/ndpscmem.htm> and the contact details for State and Territory drugs and poisons units <http://www.tga.gov.au/ndpsc/stdpu.htm> have been updated.

Public access to ARTG information

In December 2005, a discussion paper was made available on the TGA Internet site on a proposal to extend the range of information generally available to consumers on the public access part of the ARTG <http://www.tga.gov.au/consult/2005/artgaccess.htm>.

The consultation period closed on 3 February 2006 but the paper is still available.

Recalls

Two consumer-level medicine recalls <http://www.tga.gov.au/recalls/index.htm> have been published on the TGA Internet site since the last issue of TGA News.

Reminder: TGA-UPDATE email list

TGA-UPDATE is a fortnightly email detailing what's new and what's changed on the TGA Internet site and the Australia New Zealand Therapeutic Products Authority Internet site.

Anyone can subscribe <http://www.tga.gov.au/new/tga-update-subscribe.asp> to receive these emails.

TGA Internet site redevelopment

The TGA Internet site is being reviewed for its effectiveness and usability. A draft new website has been developed and we are seeking feedback on the proposed changes.

The closing date for comment on the proposed changes is 28 April 2006.

Feedback can be provided by completing an online form or by emailing comments directly to tga.website@tga.gov.au.