TGA News Issue 56 (July 2008)
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
There is an important notice for sponsors about 2008-09 annual charges on this website <http://www.tga.gov.au/fees/anncharge0809.htm>.
This notice provides important information about:
- 2008-09 annual charges
- Cancellations
- Low volume and low value declarations
- Electronic invoices
- Payments
- Liability for annual charges
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/ac-lvltexem.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>.