Advertising therapeutic products

Following a series of stakeholder consultation meetings in Australia and New Zealand in September 2004, the ninth and final meeting of the Interim Advertising Council (IAC) was held in mid-October 2004. The report of the IAC on the implementation of a trans-Tasman therapeutic products advertising regulatory scheme (including a proposed Australia New Zealand Therapeutic Products Advertising Code) will be submitted, through the TGA and Medsafe, to the Therapeutic Products Interim Ministerial Council for consideration later in 2004.

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

Excluded goods

Therapeutic Goods (Excluded Goods) Order No. 1 of 2004 took effect from 4 October 2004. This order revokes the 1998 excluded goods order.

NDPSC update

Gazette notices <http://www.tga.gov.au/ndpsc/ndpscgan.htm> associated with the June and October 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 June 2004 meeting are available.

The NDPSC meeting dates for February 2004 to June 2005 <http://www.tga.gov.au/ndpsc/index.htm> have also been updated.

Product recalls

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

• 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 <http://www.tga.gov.au/docs/html/urptg.htm> (URPTG) has been updated.

Therapeutic goods orders

Two new Therapeutic Goods Orders have been gazetted since the last issue of TGA News.

• TGO 69A Amendment to Therapeutic Goods Order No. 69 - General requirements for labels for medicines took effect on 1 July 2004. <http://www.tga.gov.au/docs/html/tgo/tgo69a.htm>
• TGO 65 Child-resistant packaging for therapeutic goods took effect on 11 August 2004. <http://www.tga.gov.au/docs/html/tgo/tgo65.htm>

Unapproved therapeutic goods

The Access to Unapproved Therapeutic Goods documents and forms have been updated and are available on the TGA website. These include: Authorised Prescribers <http://www.tga.gov.au/docs/html/authpres.htm>, Clinical Trials in Australia <http://www.tga.gov.au/docs/html/clintrials.htm>, Personal Importation <http://www.tga.gov.au/docs/html/personalimp.htm> and Special Access Scheme <http://www.tga.gov.au/docs/html/sasinfo.htm>.

You and your healthcare products

You and your healthcare products <http://www.tga.gov.au/meds/healthcare.htm> is a brochure produced as a community service by the TGA, in conjunction with industry and pharmacy stakeholders and consumers, and with the generous support of State and Territory Health Departments, the pharmacy profession and the therapeutic goods industry. The brochure is available on this website and hardcopies can be obtained from the TGA.