November December 2010 Newsletter

Issue 103 - November-December 2010	Published by Robert Forbes & Associates Pty Ltd http://www.robert-forbes.com/
This newsletter is sent to clients of RFA at no charge. You are welcome to forward this to any colleagues who may find it useful.

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Topics

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

Compliments of the season to all!
The staff at Robert Forbes and Associates wish you the compliments of the season and advise this office will be closed from 5pm Thursday 23 December 2010 and re-open at 9am on Tuesday 4 January 2011. We will be attending to your emails throughout this period.

Doing business in Australia
For our overseas clients, we draw your attention to an excellent guidance document, called Doing Business in Australia. This has been prepared by HallChadwick and it is available on their website. David Kenney is the principal author of the document and can be contacted on This e-mail address is being protected from spambots. You need JavaScript enabled to view it (HallChadwick specialises in accounting, tax and back office solutions for companies operating in Australia.)
Read more ...

TGA News

Product recall
On 8 November 2010, APO-Perindopril 2mg tablets (blister packs of 30) 2mg perindopril erbumine per tablet (Batch 24967,24979, 25180, 25184)(ARTG 151911), were issued a Class I recall as some cartons labelled 2mg perindopril tablets may contain 8mg tablets. (Sponsor ? Apotex Pty Ltd)
Read more ...

[Class I defects are potentially life-threatening or could cause a serious risk to health.
Class II defects could cause illness or mistreatment, but are not Class I.
Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.]

Consumer safety advisory
The TGA is aware that some Australian consumers have purchased the products So Hard for Men, Shaguar and Pulse8 For Women over the internet or from an Australian retailer. The labels of each these three products claim them to be 100% herbal in origin. However, analyses undertaken by the TGA in Australia and the Institute of Environmental Science & Research Limited in New Zealand have confirmed the presence of therapeutic quantities of the drug tadalafil in each of these products. None of these products has been assessed by the TGA for quality, safety or efficacy as required under Australian legislation, and supply of any of them in Australia is illegal.
Read more ...

Revised medicines and chemicals scheduling arrangements Revised scheduling arrangements for medicines and chemicals took effect on 1 July 2010. The changes include:
•	the National Drugs and Poisons Schedule Committee (NDPSC) will be replaced by the Secretary of the Department of Health and Ageing (DoHA) - or her delegate - as the decision maker for the scheduling of medicines and chemicals;
•	two new expert advisory committees, the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling, will be established to provide advice and make recommendations to the Secretary;
•	a single Secretariat, supporting both Advisory Committees, will ensure ongoing consistency and cohesiveness of processes and decisions; and
•	closer integration of the revised scheduling arrangements with existing Commonwealth evaluation and product registration schemes.
Other planned changes include:
•	the Poisons Standard, at present named the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) will be renamed the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), and
•	cost recovery arrangements are being examined.
Read more ... The details of the new arrangements are summarised in a flowchart Read more ... and fact sheet. Read more ...

Review to improve transparency of the TGA A determination of the Gillard Government to ensure the public is better informed about the benefits and risks of therapeutic goods is at the heart of a review recently announced by the Parliamentary Secretary for Health and Ageing, Catherine King. Ms King announced a comprehensive review of the way in which the TGA communicates its regulatory processes and decisions. The review will focus on improving the TGA?s transparency. The TGA is committed to improving its communication of regulatory decisions, and has already begun implementing a number of measures, including publication of:
•	Reviews of post market supply investigations into products that have triggered significant safety concerns, including those into the recent Fluvax investigations;
•	Product Information and Consumer Medicine Information for prescription medicines on the Therapeutic Goods Administration website;
•	Action taken as a result of complaints referred to it by the Therapeutic Products Adverting Complaints Resolution Panel; and
•	Results of Courts and Administrative Appeals Tribunal matters
Read more ...

Advertising complaint investigations
The TGA's policy is to publish the outcome of certain investigations into complaints about advertising which have been referred by the Complaints Resolution Panel (the Panel). Where a person fails to acknowledge or act upon a determination made by the Panel or breaches an undertaking, the complaint may be referred to the TGA. Following consideration, the TGA may then order the advertiser to take an action such as withdraw an advertisement and publish a retraction or correction. These orders (known as Regulation 9 Orders) are made under Regulation 9 of the Therapeutic Goods Regulations 1990. Information on Regulation 9 Orders after 1 November 2010 will now be provided on the site as it becomes available.
Read more ...

TGA approved terminology for medicines The TGA has updated three forms for approved terminology for medicines. The application forms are for:
-	proposing a botanical name for a herb (AHN)
-	proposing a herbal substance name (AHS)
-	proposing a herbal component name (HCN)
Read more ...

Consultation: improving advertising arrangements for therapeutic goods
Submissions from interested parties were received by the TGA in response to the consultation paper on proposed amendments to the regulation of therapeutic goods advertisements. These can be downloaded from the TGA site.
Read more ...

Australia and Canada - reciprocal recognition of manufacturers' quality systems
The TGA and Health Canada (HC) announced that the Memorandum of Understanding (MoU) on reciprocal recognition of quality management system (QMS) certificates for medical device manufacturers is now operational.
Read more ...

SMP email list
This email subscription list notifies subscribers of new information available on the TGA website for the scheduling of medicines and poisons and the expert advisory committees on medicines and chemicals scheduling.
Read more ...

Advisory committee on non-prescription medicines (ACNM)
The ACNM was formed in January 2010. The ACNM advise and make recommendations to the TGA regarding the entry of non-prescription medicines on the Australian Register of Therapeutic Goods. The ACNM supersedes the Medicines Evaluation Committee (MEC).
Read more ...

Members for advisory committees on medicines and chemicals scheduling (updated))
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TGA-industry working group (IWG) meeting outcomes, 8 July 2010
Read more ...

Therapeutic Goods Administration customer service charter
Read more ...

European union guidelines
(10 guidelines adopted, 5 guidelines replaced/superseded and 1 guideline not adopted)
Read more ...

Forms to request certificates, or notarised copies of TGA licences and certificates, in relation to the manufacture of therapeutic goods
Read more ...

FSANZ (Food Standards Australia New Zealand) update

Recall of weight loss products
Food and Health Authorities are undertaking a recall of Sumabe Acai Berry Coffee, Moti Angel Coffee and Leptin Weight Loss Chocolate. The products were found to contain the therapeutic substance, sibutramine. They were not labelled as containing sibutramine or other therapeutic substances.
Read more ...

FSANZ annual report 2009-10
Read more ...

Fact sheet - listeria and food
Listeria infection causes few or no symptoms in healthy adults and children. However, it can be very serious for people whose immune systems are weakened by disease or illness as well as pregnant women and their unborn children, newborn babies and the elderly. While health authorities seem to be getting the message across about the risk of Listeria to pregnant women, the awareness among other 'higher risk' groups is not as high.
Read more ...

Food standards news ? spring edition No75
Read more ...

Food surveillance news - spring edition
Read more ...

NICNAS News

Chemical gazette November 2010
Read more ...

Complementary Healthcare Council of Australia (CHC)

Move to a sound and healthy nation
The Complementary Healthcare Council of Australia (CHC) welcomed the passage through Parliament of the Australian National Preventive Health Agency Bill 2010 which establishes the National Preventive Health Agency to reduce preventable chronic disease and premature deaths, related to alcohol, tobacco and obesity.
"Implementing preventive measures to tackle chronic disease will improve the daily lives of many Australians. Preventive health measures will also help address the national hospital bed crisis. The Governments initiative is welcomed as a sound and healthy move" said Dr Wendy Morrow, the CHC Executive Director said. A preventive healthcare model is the key to a proactive wellness based healthcare system and complementary medicines are a major enabler at the individual consumer level. Of interest will be the National Preventive Health Agency recommendations to the Minister that will be available online, albeit after 12 months. Research will be the key to selecting the best strategies for implementation.

www.chc.org.au

Sustainable Foods Summit
January 18-19, San Francisco
Read more ...

Natural Products Expo West
March 11 ? 13, 2011 Anaheim Convention Centre, Anaheim, CA, USA
Read more ...

Natural & Organic Products Europe
April 3 - 4, 2011 Olympia, London
Read more ...

Vitafoods International
May 10 ? 12, 2011 Geneva Palexpo, Switzerland
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 ...

New half-day course now available:
•	Overview of GMP responsibilities ? including product quality reviews, stability, GMP contract agreements

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
•	Overview of advertising regulations for foods, cosmetics and medicines, for marketing executives

Full day course
•	Food Standards

For more information visit the RFA website

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Robert Forbes & Associates Pty Ltd
Regulatory Affairs Consultants
Phone: 61 2 96608027 - Fax: 612 96608106 Postal: PO Box 123, Annandale NSW 2038 AUSTRALIA
Office: 335 -341 Glebe Point Road (Entrance Ferry Rd - Level 1), Glebe SYDNEY, NSW AUSTRALIA

Last Updated on Wednesday, 11 May 2011 09:49

robert-forbes.com.au - Robert Forbes and Associates - Regulatory and technical advice to suppliers and manufacturers of complementary medicines, dietary supplements, OTC medicines, cosmetics, personal care products and foods.

November December 2010 Newsletter

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