Issue 86 - November 2008
The Essential Technical & Regulatory E-News - Australian & International
Provided by

Robert Forbes & Associates Pty Ltd
Regulatory Affairs Consultants


The RFA team would like to wish you the compliments of the season and a healthy happy 2009!

Please note that this is our last scheduled newsletter for 2008, however if any important information arises before our next newsletter at the end of January we will of course send you an update before then.

The RFA office will close on Tuesday 23 December 2008 at 5.00 pm and re-open on 12 January 2009 at 9.00 am.

Click here to view this newsletter in your web browser

• RFA News
• Medicines
     • TGA news
• Foods
     • FSANZ update
• Cosmetics
• Conferences and meetings
• RFA training courses

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RFA website named MOST OUTSTANDING WEBSITE for 2008 October 30, 2008 - At the annual Complementary Healthcare Council Awards, the RFA website was awarded the MOST OUTSTANDING WEBSITE. The award, presented by Dr Wendy Morrow, CHC president, was given in recognition of the excellence of the RFA website. The award recognises the complementary healthcare product industry’s best website based on functionality, creativity and relevance of content and branding.

The site showcases a world-first on-line vitamin converter, developed by RFA. This converter has a number of uses; for example, enter an amount of vitamin and the tool will convert it into IU. Alternatively, enter an amount of sodium ascorbate and the tool will convert this into the equivalent amount of ascorbic acid - or thiamine nitrate to thiamine - the list goes on! There are mineral equivalence charts, charts detailing product claims and appropriate levels of evidence, as well as a summary of permitted claims for Listable goods.

The site offers time saving, useful, practical resources to marketing, technical and management executives in the complementary, OTC medicine, cosmetic and food industries. Visit the new-look RFA website and be sure to take a look at our world-first online vitamin converter.

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Product recalls and adverse events
On 5 November Zhen De Shou 10 x 250mg capsules in 10-day trial pack or 1 month supply, were issued a Class I recall due to the fat loss capsules being illegally supplied to the market. The prescription-only (S4) medicines Sibutramine and Phenolphthalein were detected in a sample. These medicines must only be used under medical supervision. (Sponsor – Mellissa Hrovat t/a No Fuss Weight Loss)
Read more ...

In October, the TGA investigated reports of adverse events associated with the use of Peripherally Inserted Central Catheter (PICC) lines in Queensland. The TGA liaised with Queensland Health on the issue as well as with other international regulatory agencies to determine whether this was a worldwide issue. The results of their investigation have shown that there are no inherent flaws in any of the PICC lines. However, as with all medical devices it is important that Instructions for Use are carefully followed.
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[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.]

Therapeutic goods amendment legislation
The Therapeutic Goods Amendment Legislation (Annual Charges) Bill 2008 (The Amendment Act) was introduced in the 2008 Winter Sittings of Parliament in June 2008 and received Royal Assent on 3 October 2008.

The Amendment Act makes a number of amendments relating to the collection and imposition of annual charges, and the implementation of exemptions from liability to pay annual charges because of low value turnover of therapeutic goods. It is expected that the Amendment Act will commence from 1 January 2009.
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Request to transfer the sponsorship of an ARTG entry
Relinquishing company – form to be used by the relinquishing company to request the transfer of sponsorship.
Read more ...

Accepting company – form to be used by the accepting company regarding the request to transfer sponsorship.
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Membership of TGC
The Therapeutic Goods Committee has 10 members, including experts in various fields relevant to therapeutic goods regulation, and nominees of organisations which represent the interests of the main sectors of the therapeutic goods industry, as well as consumers of health services. Nominees of organisations are appointed on the basis of their individual skills, knowledge and expertise and are not considered to be representatives of the nominating organisations. For current membership click here ...

CMEC 68th meeting – ratified minutes
At the Complementary Medicines Evaluation Committee’s 68th meeting the following recommendations were made to the TGA:

-    herbal preparations of the root, rhizome and/or stolons of Glycyrrhiza glabra and Glycyrrhiza uralensis are suitable as ingredients in Listed therapeutic products, subject to labelling advising of the potential for adverse effects in at-risk individuals, with wording to the effect:
"Contains liquorice. Not suitable for people with a history of high blood pressure, or who are pregnant, or have kidney disease".
-    only herbal preparations of the fruit resin of Daemonorops draco are suitable for use as an ingredient in Listed medicines.
-    Listed medicines containing phytosterols require a label advisory statement with words to the effect: "There is no benefit from taking more than 3g/day of phytosterols from all sources" AND "Not suitable for pregnant or lactating women".
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CMEC 69th meeting
At the Complementary Medicines Evaluation Committee’s 69th meeting the following recommendations were made to the TGA:
-    preparations of the root of Stemona sessilifolia and Stemona japonica, for oral administration, are suitable for use as ingredients in Listed medicines when prepared according to the methods described in the current edition of the Pharmacopoeia of the People's Republic of China, and subject to a recommended maximum daily dose of 9g equivalent dry root.
-    preparations of Dryopteris crassirhizoma (thick stem wood fern) are not suitable for use as ingredients in Listed medicines.
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Therapeutic Goods Order No 78
The revised standard for tablets and capsules is now available. For a summary of changes contact RFA.
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Client details form - updated
This form should be completed by each client involved with the supply of the therapeutic goods in Australia for which the TGA requires address details.
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Newly published European guidelines
Read more ...

TGA news issue 57
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TGA legal expenditure 07/08
Read more ...

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Food ministers consider food labelling review
At the twelfth meeting of the Australia and New Zealand Food Regulation Ministerial Council it was agreed in principle to commission an independent, comprehensive review of food labelling law and policy. The review will be undertaken by an independent expert panel.
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Food code proposed changes
FSANZ invites comment on two applications to amend the Australia New Zealand Food Standards Code. The applications are for two enzymes for use as processing aids in the food industry:

-    phospholipase A2 derived from a genetically modified source and a cellulose enzyme preparation produced by fermentation from a non-genetically modified source.
-    Danisco is seeking to amend the Code to allow the use of a cellulase enzyme preparation, produced by fermentation from a non-toxigenic and non-pathogenic strain of Penicillium funiculosum as a processing aid.
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FSANZ considers approving voluntary addition of fluoride to bottled water
Food Standards Australia New Zealand (FSANZ) released a report for public comment that proposes amending the Australia New Zealand Food Standards Code to allow manufacturers to voluntarily add fluoride to bottled water.  The addition of certain substances, such as fluoride, must undergo a pre-market safety evaluation by FSANZ before they are approved for use at specified levels.

If FSANZ approves the sale of bottled water containing added fluoride, it will be a voluntary permission.
Read more ...
Fact sheet ...

Health advisory labels on alcoholic beverages
FSANZ is working on two projects that involve the labelling of alcoholic beverages.  The first project is Application A576, an application to amend the Code to require health advisory statements on packaged alcoholic beverage labels advising of the risks of drinking alcohol when planning to become pregnant and during pregnancy. The second project came from the Australia and New Zealand Food Regulation Ministerial Council in their request to consider mandatory health advisory statements on packaged alcohol to help curb alcohol misuse.
Read more ...

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At the beginning of October, NICNAS, the National Industrial Chemicals Notification and Assessment Scheme, released a Draft Priority Existing Chemical (PEC) Report for Triclosan. Triclosan is used in low concentrations in many consumer products as an anti-microbial. The report also makes recommendations for safe use.
Read more ...

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World Self-Medication Industry Symposium on Self Care in Healthcare Systems & FIP-WSMI Symposium on Medicines – Traditional, Alternative & Complementary
November 7-9, Beijing, China
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ASMI Annual Conference & AGM
November 19, Australian Technology Park, Redfern Sydney
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Integrity in Advertising Therapeutic Goods to consumers
TGACC advertising training seminars 2008 schedule
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TGA International Training Calendar
Available for staff of overseas government regulatory organisations only
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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

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Robert Forbes & Associates regularly conducts training courses for clients in our Glebe office meeting room. Courses are conducted with up to five people from only one client at a time. Courses can be tailored to suit your needs, based on your product types and to address any regulatory issues you may be facing.

Half day (4 hour) courses
   • Overview of the Food/therapeutic/cosmetic interface
   • Cosmetic regulation
   • Advertising code
   • Researching levels of evidence for product claims and indications
   • TGA online applications
   • Finished product specifications

Full day courses
   • 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

Copyright 2008 Robert Forbes & Associates Pty Ltd. All rights reserved.

Disclaimer: Whilst Robert Forbes & Associates has made every effort to be accurate, errors may appear and are inadvertent.

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