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Issue 95 - September 2009	Published by Robert Forbes & Associates Pty Ltd http://www.robert-forbes.com/
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This issue of Current Affairs is proudly sponsored by
the Complementary Healthcare Council of Australia

The CHC is the leading expert association exclusively committed to a vital
and sustainable complementary healthcare products industry.

Join the CHC NOW and
receive 50% off your membership fee!
Read more ...

Topics

Medicines
- TGA News
Foods
- FSANZ Update
Association News
Conferences and Meetings
RFA Training Courses

TGA News

Second Act to enhance the Therapeutic Goods Act 1989 given Royal Assent On 27 August 2009 the Therapeutic Goods Amendment (2009 Measures No 1) Act 200 was given Royal Assent. From Friday 28 August:
•	medicines and therapeutic devices will be able to be suspended rather than fully cancelled in certain circumstances;
•	monitoring of facilities will now be able to include the taking of video and other recordings and taking of samples of things related to therapeutic goods on premises;
•	other minor amendments including clarifying the definition of accessory to a medical device and requiring that medicine labels not make claims that are inconsistent with the claims approved for the product; and
•	minor technical amendments to the expression of legislative instruments in the Act.
From 1 July 2011:
•	a new framework for the regulation of homoeopathic and anthroposophic medicines will come into effect.
From dates to be advised the following will be enabled within the next 6 months:
•	manufacturing licenses to cover single sites, except in certain circumstances, and enabling variation and transfer of licenses to another manufacturer;
•	the Minister will be able to determine lists of ingredients that are permitted and prohibited to be included in listed medicines.
•	other amendments including clarification of the way conditions are set on registered and listed goods and clarifying the Advertising Code as a legislative instrument.
More information on the Therapeutic Goods Amendment (2009 Measures No 1) Act 2009 is on the ComLaw website ... Read more ...

Changes to process of posting CMEC recommendations on TGA website To date, certain recommendations made by CMEC to the TGA have been posted on the TGA website shortly after the CMEC meeting has been held. As these recommendations have not been ratified by the CMEC or endorsed by the TGA, these recommendations have, on occasions, required amendment or have been rescinded. The TGA recognises the potential confusion this has caused and therefore has considered it necessary to amend this process. Accordingly, as of September 2009 (CMEC 73):
•	CMEC recommendations (and reasons) will be posted on the TGA website only after ratification by the Committee (at their next meeting).
•	While as much information as possible will be made public, information considered confidential will continue to not be released.
Read more ...

Consultation on draft code of good wholesaling practice for medicines
The National Co-ordinating Committee of Therapeutic Goods is seeking comment from interested parties on a new code of good wholesaling practice for scheduled medicines, to be introduced under state and territory legislation. The closing date for comment is Friday 23 October 2009.
Read more ...

PIC/S guide for GMP for medicinal products
The purpose of PIC/S is to facilitate the networking between participating authorities and the maintenance of mutual confidence, the exchange of information and experience in the field of GMP and related areas, and the mutual training of GMP inspectors. Australia is a member of the PIC/S. The guides are available to download.
Read more ...

New TGA requirements for microbiology
A copy of a presentation given by Karen Longstaff at ARCS Australia Ltd (Sydney on 7 September 2009) is available to view. The presentation covered: What’s new in TGO 77; Sponsor obligations under TGO 77; Relationship between TGO 77 and ARGPM Appendices 16 & 17; Common deficiencies with applications in the field of microbiology; and What could industry do better in relation to microbiology.
Read more ...

Review of Schedule 1 to TGO 80
A review of Schedule 1 to the Therapeutic Goods Order No. 80 Child-Resistant Packaging Requirements for Medicines (TGO 80) is to be undertaken by the Therapeutic Goods Committee (TGC) at its next meeting, scheduled to be held on 14 October 2009. TGO 80 specifies requirements relating to the child-resistant packaging (CRP) of medicines which may present a significant risk of toxicity to children if accidentally ingested. Schedule 1 to TGO 80 identifies those substances and classes of substance which, if present in a medicine, necessitate that the medicine has CRP.
Read more ...

TGA OCM An update on the staff and structure of the Office of Complementary Medicines (OCM) is now available. The OCM consists of three functional groups:
•	the PreMarket Assessment Section
•	the Listed Medicines and Communications Section and
•	the Post Market Review Section.
Read more ...

Low value turnover exemption from annual charges – deadline extended
The TGA has extended the due date for applications for Low Volume Threshold (LVT) exemptions from 1 September to 1 December 2009.
An exemption from the liability to pay an annual charge for a therapeutic good entered on the Australian Register of Therapeutic Goods (ARTG) that has a 'low value' turnover (LVT) can be sought from the TGA.
Read more ...
Low value turnover form ...

European Union guidelines (updated)
EU guidelines recommended for adoption or non-adoption.
Read more ...
Guidelines proposed for adoption in Australia ...

FSANZ (Food Standards Australia New Zealand) update

Listeria advice
Listeria monocytogenes is a microorganism that may cause an infection called Listeriosis following the consumption of contaminated food. While this organism has little impact on healthy people, more severe illness may occur in immuno-compromised individuals, pregnant women and their babies, young children, cancer patients, AIDS patients, and the elderly.
Read more ...

How much salt and sodium are we eating
Following the release of the May 2009 fact sheet, How much salt and sodium are we eating?, many enquiries have been taken about the accuracy of FSANZ predicted salt intakes and the age of the data we used to generate these intake estimates. The new fact sheet is intended to clarify some of these matters.
Read more ...

Palm oil and food
A number of people have contacted FSANZ calling for the labelling of palm oil as they are concerned around the destruction of native rainforest habitat for orangutans due to an expansion of farmed palm oil plantations in certain parts of the world.
Read more ...

Choosing healthier fats and oils
Fat is listed on labels in the nutrition information panel as saturated fat and as total fat (which also includes trans fatty acids, polyunsaturated fats and monounsaturated fat). The total fat present in food is generally made up of a combination of fat types, with one type of fat more predominant than others, depending on the food. This fact sheet explains the different types of fat.
Read more ...

Food surveillance news winter 09 Winter edition 2009 is now available which covers:
•	FSANZ releases report on the Analysis of Food-Related Health Risks
•	Planning for the 24th Australian Total Diet Study
•	Salmonella in Peanuts and Pistachios from the United States
•	A snapshot of surveillance activities abroad
•	Keeping an eye on food recalls
•	FSANZ attends the 42nd Annual AIFST Convention
•	FSANZ provides microbiological risk assessment training in Malaysia
Read more ...

Complementary Healthcare Council of Australia (CHC)

Membership offer
To take advantage of the new member membership fee of 50% off*, click here *No need to renew until July 2010. This one-time only offer is limited to businesses that have not been members of the CHC since June 2008.
For any membership needs contact 02 6260 4022 or members@chc.org.au.

CHC industry awards 2009
The CHC 10th Anniversary Industry Awards 2009 will be held in Sydney on 29 October. The Gala Dinner will feature speakers from the CHC's ten year history, award presentations by Parliamentary Secretary for Health Mark Butler and entertainment by Comedian of the Year winner, Anh Do.
All CHC Members can nominate or be nominated for the awards which will be presented at the dinner. The closing date for Award Nominations has been extended until COB Monday 28 September 2009.
CHC Industry Awards 2009 Nomination Booklet ...
CHC Industry Awards 2009 Gala Dinner Details ...

www.chc.org.au

National Herbalists Association of Australia (NHAA)

NHAA 2009 seminar series
The changing face of herbal practice with Sue Evans
Sydney Sat 10 October

For more details see www.nhaa.org.au or phone (02) 8765 0071
NHAA 8 CPE points

www.nhaa.org.au

Natural Products New Zealand (NPNZ)

2010 Natural Products Summit
Natural Products New Zealand has set the date for the 2010 Natural Products Summit. Mark April 22, 2010 in your diary now!

www.naturalproductsnz.org

ACCORD Australasia's National Conference
October 20 - 23, The Hotel Windsor, Melbourne
Read more ...

CHC 10th Anniversary Industry Awards
October 29, The Tea Room, Queen Victoria Building, Sydney
Read more ...

Supply Side West
November 11 – 13, The Venetian and Sands Expo, Las Vegas
Read more ...

TGACC advertising seminars – Fundamentals 9-4pm
Nov 6 – Brisbane
Nov 18 – Adelaide
Nov 20 – Perth
Nov 25 – Sydney
Dec 8 - Melbourne
Read more ...

ASMI Annual Conference & AGM
November 12, Australian Technology Park, Redfern Sydney
Read more ...

Panacea 2010
February 3 – 5, 2010 World Trade Centre, Mumbai, Maharashtra, India
Read more ...

Biofach Germany
February 17 – 20, Exhibition Centre Nuremberg, Germany
Read more ...

Natural Products Expo West
March 11 – 14, 2010 Anaheim Convention Centre, California, USA
Read more ...

GMP Management Course
ASMI in partnership with the Advanced Manufacturing Centre and the University of NSW has created a course on GMP management which culminates in a graduate certificate. This course is open to members and non-members of ASMI.
Read more ...

Half day (4 hour) courses
•	Overview of the food/therapeutic/cosmetic interface
•	Cosmetic regulation
•	Medicines - advertising code
•	Medicines - product claims and indications
•	Listed complementary medicines - TGA eBS online applications
•	Medicines – the sponsor’s finished product specifications

Full day course
•	Food Standards

For more information visit the RFA website

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Robert Forbes & Associates Pty Ltd
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