21st NRL Workshop on Serology

The 20th NRL Workshop on Serology will be held on 13-15 August 2003 at the Surfers Paradise Marriott Resort in Queensland. Prominent international guests have been invited and national speakers will offer the Australian context.

For more information see the NRL website <http://www.nrl.gov.au>.

Advertising therapeutic products

A new draft of the Australia New Zealand Therapeutic Products Advertising Code and other information on the development of a trans-Tasman advertising scheme for therapeutic products including approval and complaints processes is available.

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

Khat information sheet

A new khat information sheet covering the import of khat, controls in Australia and current actions overseas is available.

Legislation changes

A summary of legislation changes <http://www.tga.gov.au/legis/changes.htm> is available on this website.

NDPSC meetings

Gazette notices <http://www.tga.gov.au/ndpsc/ndpscgan.htm> associated with the October 2003 and February 2004 meetings of the National Drugs and Poisons Schedule Committee and the record of reasons for the October 2003 meeting <http://www.tga.gov.au/ndpsc/record/rr200310.htm> are available.

Product recalls

Two consumer-level recalls have occurred since the last issue of TGA News.

• See: Medicine & medical device recall notices <http://www.tga.gov.au/recalls/index.htm>

The list of Recall Coordinators in the Uniform Recall Procedure for Therapeutic Goods (URPTG) <http://www.tga.gov.au/docs/html/urptg.htm> has been updated.

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Product contamination & extortion - a protocol for the therapeutic goods industry

The document Product contamination & extortion - a protocol for the Therapeutic Goods Industry <http://www.tga.gov.au/recalls/igcmc_cont.htm> has been developed by the Industry Government Crisis Management Committee (IGCMC) as a joint industry-government initiative, with the aim of assisting managers in responding to a product contamination and/or extortion event directed at the therapeutic goods industry.

Quality of anti-retroviral medicines

TGA Laboratories has agreed to be one of five international laboratories that will develop robust test methods and specifications for the family of anti-retroviral medicines that are currently available in international commerce. The work will involve generating validated analytical procedures for the active materials and for the finished products. These procedures can then be used with confidence by countries that may not have the capacity to develop such quality control measures. The cost of the work will be met by the World Health Organization.

More information: TGA Laboratories to participate in international program on the quality of anti-retroviral medicines <http://www.tga.gov.au/international/whoarv.htm>

Requests to defer charges or pay by instalment

All fees and charges imposed by the TGA are a debt due and owing to the Commonwealth. Unless there is a statutory exemption, the TGA has no discretion to waiver a charge imposed.

In a situation where it is not possible or reasonable for an amount to be paid in full immediately, a Delegate of the Minister for Finance and Administration may agree to enter into an arrangement to allow payment by instalments or in full at a deferred date.

More information: Requests to defer charges or pay by instalment

Review of applications for declaring the turnover of low volume and low value products

In February 2004 the TGA undertook a review of applications made by sponsors to exempt products from annual charges due to low volume and low value turnover.

TGA contacts list

A copy of the TGA Contacts List is supplied as an insert with this issue of TGA News.

TGA website address

The TGA's website address is <www.tga.gov.au>. Other addresses may also work for the moment, but we suggest changing favourites and links to this address.

TGC 22

The report on the 22nd meeting of the Therapeutic Goods Committee <http://www.tga.gov.au/docs/html/tgcminu.htm> is available on the TGA website.