Customer service charter

Thank you to everyone who commented on the draft TGA Customer Service Charter. All responses are being considered and the final charter will be available soon on this Internet site.

Fees & charges

TGA fees & charges have recently been updated and the new amounts apply from 20 August 2005.

More information: TGA fees & charges <http://www.tga.gov.au/docs/html/feesach.htm>

NDPSC update

Gazette notices associated with the October and June 2005 meetings <http://www.tga.gov.au/ndpsc/ndpscgan.htm> of the National Drugs and Poisons Schedule Committee and the record of reasons for the June 2005 meeting <http://www.tga.gov.au/ndpsc/records.htm> are available.

At its October 2005 meeting, the NDPSC considered a proposal to make the prescription medicine oseltamivir (Tamiflu) available from pharmacists over the counter for the treatment and prevention of influenza type A and B.

The Committee considered the material presented to it and concluded that its current prescription-only scheduling status remains appropriate at this time.

New & updated forms & publications

Three new forms are available and one has been updated:

• Report of suspected adverse reaction to medicines/vaccines ('blue card') <http://www.tga.gov.au/adr/bluecard.htm> (updated)
• Authorisation to cancel a product from the Australian Register of Therapeutic Goods <http://www.tga.gov.au/fees/forms/artg-cancel.htm> (new)
• Application for certificate of free sale or export certificate for a therapeutic device/medical device <http://www.tga.gov.au/devices/cfs-expc.htm> (new)
• Nomination form for electronic billing <http://www.tga.gov.au/fees/forms/elecbilling.htm> (new)

The following publications have been updated:

• The Standard for the Uniform Scheduling of Drugs and Poisons <http://www.tga.gov.au/ndpsc/susdp.htm> (SUSDP) No. 20 is now available
• The Therapeutic Goods Advertising Code 2005 <http://www.comlaw.gov.au> took effect on 24 August 2005 and is available from the ComLaw Internet site
• Australian Regulatory Guidelines for Complementary Medicines (ARGCM) Part IV General Guidance <http://www.tga.gov.au/docs/html/argcm.htm#argcmp4>
• Australian Regulatory Guidelines for OTC Medicines (ARGOM) Chapter 10 Sunscreens <http://www.tga.gov.au/docs/html/argom.htm>

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Recalls

Two consumer-level medicine recalls have occurred and one medical device hazard alert has been issued since the last issue of TGA News. See: Recalls & alerts <http://www.tga.gov.au/recalls/index.htm>

TGA-UPDATE email list

TGA-UPDATE is a fortnightly email detailing what's new and what's changed on the TGA Internet site and the Trans Tasman Therapeutic Products Agency Project Internet site.

Anyone can subscribe to receive these emails.

• Subscribe to the TGA-UPDATE email list <http://www.tga.gov.au/new/tga-update-subscribe.asp>

Trans Tasman joint agency

Pharmacopoeial standards for medicines

In September 2005, a document on pharmacopoeial standards for medicines in the joint agency <http://www.anztpa.org/consult/pharmacopoeia.htm> was made available for consultation.

The consultation period closed on 14 October 2005 but the document is still available on the Trans Tasman Therapeutic Products Agency Project Internet site.

Scheduling of medicines and poisons

In July 2005, a document on a proposed new model for the scheduling of medicines and poisons within the joint agency <http://www.tga.gov.au/consult/2005/scheduling.htm> was made available for consultation.

Comments were received from 19 stakeholders on the proposed new scheduling model and the scheduling policy framework. These submissions are under consideration by the National Co-ordinating Committee on Therapeutic Goods.