General news

Fees & payments

2008-09 fees & charges

Changes to the TGA's fees and charges for the 2008-2009 financial year took effect from 1 July 2008.

Details: Fees & payments <http://www.tga.gov.au/docs/html/feesach.htm>.

2008-09 annual charges

2008/09 annual charges

Annual charges invoices for the 2008/09 financial year will be sent 3 weeks earlier than in the previous year which will allow sponsors more time to review all their ARTG listings. Otherwise, arrangement for processing annual charges largely remains the same as last year and is outlined below:

• Invoices for annual charges will be issued to Sponsors by 11 July 2008 for all products entered on the ARTG as at 1 July 2008. These invoices will form a complete list of product entries for each Sponsor. Any discrepancies or omissions from the list of product entries should be notified to the TGA immediately.
• Sponsors will have more than two months to review the product range listed in the invoice and identify products which should be cancelled (where supply ceased before 1 July 2008) and products for which an LVLV exemption will be sought.
• The due date for payment of the invoice will be 1 October 2008.
• The amount due will be:
  • The invoice amount;
  • LESS annual charge (as per invoice) for each cancelled product;
  • LESS the invoice value for each product for which an LVLV exemption has been claimed;
  • PLUS the application fees payable for LVLV exemption declarations (per product).
• Where a reduction to the invoice amount is to be made, Sponsors must forward a copy of the invoice to the TGA by mail or facsimile (02 6232 8222), together with their payment and any cancellation forms and/or LVLV declarations signed by an authorised officer.
• Sponsors electing to pay by instalment must ensure the initial instalment is made by the invoice due date. The initial instalment payment must be at least one quarter of the amount remaining after cancellations and LVLV exemptions are deducted. Note that application fees for LVLV declarations are payable in full by the due date.

Cancellations

Sponsor cancellations must be made using the cancellation form available on our Website at Authorisation to cancel a product from the Australian Register of Therapeutic Goods <http://www.tga.gov.au/fees/forms/artg-cancel.htm>.

Low volume and low value declarations

Applications to declare that the turnover of a product is of low volume and low value in accordance with Regulation 4C of the Therapeutic Goods (Charges) Regulations 1990 should be submitted together with the applicable fee(s) before the due date of payment.

• Applications to declare that the turnover of a product is of low volume and low value must be made on the form available on our Website at Application for declaration that turnover is of low volume and low value <http://www.tga.gov.au/fees/forms/lowvalue.htm>.
• The 2008/09 LVLV applications for products that had no turnover in 2006-07 must be submitted by using 2009-10 estimate of sales. The TGA may contact you later in the year to validate your estimate.
• Applications for declarations relating to products invoiced in late 2007-08 must be finalised by the due date specified on the annual charges invoice. The TGA will not accept applications relating to 2007-08 after 31 July 2008.

Electronic invoices

Less than 50% of Sponsors have elected to receive their annual charges invoices electronically. As electronic invoicing improves the timeliness and delivery of invoices, the TGA encourages sponsors to register for receiving their invoices electronically.

• If you would like to receive your invoice electronically, simply complete a registration form available on our website at Electronic invoices nomination form <http://www.tga.gov.au/fees/forms/elecbilling.htm>.
• Note that only two (2) email addresses per Sponsor can be accepted.
• Forms should be submitted to the TGA Accounts Receivable Manager by facsimile on 02 6232 8222, or by email to TGA.Accounts@tga.gov.au

Payments

The TGA will again permit Sponsors to spread their liability for annual charges over the financial year in quarterly instalments. The instalment dates for payment of instalments in 2008-09 will be as follows:

Quarter 1	1 October 2008
Quarter 2	1 December 2008
Quarter 3	1 March 2009
Quarter 4	1 June 2009

• Failure to make an instalment payment by 1 October will forfeit the option of making instalment payments for the remainder of the year. The full amount of the invoice will become payable. Failure to pay a subsequent instalment by the due date will also cause the balance of the account to fall due immediately. However transfers of products can not be completed until outstanding amounts are settled in full.
• Sponsors will be able to make payments for annual charges online by credit card (for amounts up to $15,000) or by direct debit from a savings or cheque account. Details of payment options and a link to our online payment portal are available on our Website at Payment of accounts <www.tga.gov.au/docs/html/feesach.htm#payment>.

Liability for annual charges

Annual charges are imposed under Regulation 3 of the Therapeutic Goods (Charges) Regulations 1990 and represent a cost recovery tax. Annual charges are payable for any entry on the ARTG in respect of a financial year unless the product is declared to have a turnover that is of low volume and low value.

• Annual charges apply in respect of the financial year (or part there-of) and are not adjusted where a product entry or cancellation occurs during the year.
• The TGA has no power for the waiver of annual charges other than for products declared to have a turnover that is of low volume and low value.
• Sponsors that have not advised the TGA of the cancellation of a product by the due date for payment will remain liable for the annual charge for the product(s) as these products will be deemed to have been an entry on the ARTG for 2008-09.
• Sponsors that cancel a product, or have a product suspended or cancelled by the TGA during the course of the year, remain liable for any outstanding instalments that may be due on the product entry.

All enquiries regarding arrangements for 2008-09 annual charges should be directed to the TGA Accounts Receivable Manager on 02 6232 8264 or by email to TGA.Accounts@tga.gov.au.

Low volume & low value exemptions

Annual charges are not payable in respect of therapeutic goods (including medical devices) entered on the ARTG that have been declared to have low volume and low value turnover. See Low volume and low value exemptions from annual charges <http://www.tga.gov.au/fees/lowvalue.htm> for more information, including:

• Key points
• Procedures
• Forms
• Assistance
• References
• Low volume & low turnover thresholds

Cost recovery impact statement

Each year the TGA reviews its fees and charges in consultation with industry associations. Generally, fees and charges are increased in line with annual average wage and cost movements. Significant changes to regulatory arrangements of new regulatory proposals involve additional consultation with affected sectors and result in the preparation of cost recovery impact statements.

In developing the 2008-09 TGA operating budget, it was identified that fees and charges in the nonprescription (registered) medicines sector would not achieve full cost recovery. The TGA had proposed significant increases to fees and charges that would move the sector towards full cost recovery [in 2007-08], however a decision was taken to defer action and address the under recovery in the (then) upcoming joint regulatory scheme with New Zealand, the Australia New Zealand Therapeutic Products Agency (ANZTPA).

Given that the establishment of ANZTPA has been postponed for the foreseeable future, and that the non prescription (registered) medicines sector continues to under recover its costs, the TGA consulted with the Australian Self Medication Industry (ASMI) in February 2008 and notified that the ongoing under-recovery would be addressed in 2008-09.

For more information, see the cost recovery impact statement Annual review of fees and charges 2008-09 - Non-prescription (registered) medicines <http://www.tga.gov.au/fees/cris-npfees0809.htm>.

Business plan

The TGA Business Plan 2008-09 <http://www.tga.gov.au/about/tgabp0809.htm> is an integral part of the framework that will guide the TGA's work during the next financial year and identifies continuing responsibilities and major project initiatives planned for this period.

Excluded goods order

Therapeutic Goods (Excluded Goods) Order No. 1 of 2008 <http://www.tga.gov.au/legis/tgeg0801.htm> was published in the Commonwealth of Australia Gazette, No. GN 23, on 11 June 2008.

This order replaces and revokes Therapeutic Goods (Excluded Goods) Order No.1 of 2005.

Nanotechnology

The term 'nanotechnology' is used to describe a wide range of methods involved in the production and engineering of structures and systems by controlling size and shape at the nanometre scale.

When used in therapeutics, nanotechnologies have been defined as the application of nanotechnologies (or nanomedicine) for the purpose of making a medical diagnosis or treating disease.

There is now a list of questions and answers about nanotechnology and therapeutic products available on the TGA website <http://www.tga.gov.au/meds/qanano.htm>.

BP 2008

From 1 July 2008, the definition of "British Pharmacopoeia" in the Therapeutic Goods Act 1989 is the British Pharmacopoeia 2008 <http://www.tga.gov.au/legis/bp2008.htm>.

NDPSC

Gazette notices associated with the February and June 2008 meetings of the National Drugs and Poisons Schedule Committee and the record of reasons for the February 2008 meeting are available >http://www.tga.gov.au/ndpsc/index.htm>.

The Standard for the Uniform Scheduling of Drugs No. 23 took effect from 1 June 2008. An order form is available on the TGA website <http://www.tga.gov.au/ndpsc/susdp.htm>.

NCCTG

The membership details of the National Co-ordinating Committee for Therapeutic Goods have been updated <http://www.tga.gov.au/docs/html/ncctg.htm>.

TGC

A meeting summary and a meeting report from the 32nd meeting (April 2008) of the Therapeutic Goods Committtee are available on the TGA website <http://www.tga.gov.au/docs/html/tgcminu.htm>.

Recalls

One consumer-level medicine recall has occurred since the last issue of TGA News <http://www.tga.gov.au/recalls/index.htm>.

The recall coordinators list has been updated in the Uniform Recall Procedures for Therapeutic Goods <http://www.tga.gov.au/docs/html/urptg.htm>.

TGA website changes

Since the last issue of TGA News, there have been a couple of changes to the TGA website:

• There is now a new topic under the 'Regulation' section: 'IVDs & other therapeutic goods'. This area contains information about the regulation of in vitro diagnostic devices, sterilants & disinfectants and tampons. <http://www.tga.gov.au/othertg/index.htm>
• The chemicals information has been moved off the TGA website and onto the Department of Health and Ageing website <http://www.health.gov.au>.