Fees and charges

On 1 July 2004 most of the TGA's fees and charges increased by 3.05% reflecting movements in wage costs and consumer prices. A number of other changes have also been made to fees and charges this year, and include:

• reductions in evaluation fees for most prescription medicines, with a concurrent increase in annual charges, as part of a five-year strategy to re-balance the proportion of costs being recovered through pre-market fees;
• the removal of annual charges for export only medical devices;
• a reduced annual fee for listed and registered devices that will not transfer to the new regulatory framework for medical devices introduced in October 2002;
• the creation of separate licence and inspection charges for the manufacture of human tissues;
• introduction of fees relating to the approval of advertisements intended for the broadcast media as a result of the transfer of functions from the Broadcasting Services Act 1992;
• additional increases to annual licence charges for primary and secondary blood manufacturing sites; and
• clarification of fees applicable for devices incorporating a medicinal component and a medicine incorporating a device component.

The new fees and charges <http://www.tga.gov.au/docs/html/feesach.htm> are now available.

Sponsors are encouraged to check the fee schedule to ensure correct payment is made for applications and evaluations submitted after 1 July 2004.

Forms updates

A number of TGA forms have recently been updated:

• Application for a licence to manufacture therapeutic goods <http://www.tga.gov.au/docs/html/gmpapp.htm>
• Client details form <http://www.tga.gov.au/docs/html/forms/clientdt.htm>
• Forms for accessing unauthorised therapeutic goods

A subscription order form for the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) <http://www.tga.gov.au/ndpsc/susdp.htm> is also now available.

NDPSC update

Gazette notices <http://www.tga.gov.au/ndpsc/ndpscgan.htm> associated with the February and June 2004 meetings of the National Drugs and Poisons Schedule Committee (NDPSC) and the record of reasons <http://www.tga.gov.au/ndpsc/records.htm> for the February 2004 meeting are available.

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

Review of the URPTG

In 2002, the TGA engaged an independent consultant to review the Uniform Recall Procedure for Therapeutic Goods (URPTG). The consultant reviewed the recall processes for therapeutic goods undertaken in accordance with the URPTG and also took into account issues arising from the Pan recall. A draft report was released for stakeholder consultation in November 2003. Comments were reviewed and incorporated into the final report which was accepted by the National Co-ordinating Committee on Therapeutic Goods at its April 2004 meeting.

More information: Review of the Uniform Recall Procedure for Therapeutic Goods <http://www.tga.gov.au/recalls/urptg_rev.htm>

TGA website

The TGA's website address is http://www.tga.gov.au. The old address (www.health.gov.au/tga/) no longer works so we suggest you change your favourites and links to the correct address.

Trans Tasman advertising scheme

Minutes from meetings 4 and 5 of the Interim Advertising Council and minutes from Australia and New Zealand consultation meetings are available.

The Draft Australia New Zealand therapeutic products advertising code is also available.

• See: Development of a trans Tasman advertising scheme for therapeutic goods <http://www.anztpa.org/advert/advtt.htm>